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Published by Renee Williams, 2019-05-23 21:31:50

05232019_Business Plan_Flipbook - 02

05232019_Business Plan_Flipbook - 02

Greeting Vinay,

In accordance with the guidelines set forth for the Individual Project Course, attached please find for your assessment a
business plan for BioTune ComputationsTM (BTC). BTC is an LLC I founded November 2018. Briefly, it is a B2B software

company that crafts customized platforms for the end-to-end computational needs of research laboratories.

I attempted to incorporated as many relevant course concepts into the plan, which I have detailed below:

Role of the General Assessments SWOT, PEST, stakeholder analysis and balanced scorecard, competitive forces,
Manger strategic & operational health analysis

Planning Executive summary, strategic map (vision, mission, objectives, thrusts, action
plan), value proposition, core competences, operational plan

Financial Accounting Statements Proforma income (profit & loss), projected cash flow

Business Strategy Market Entry Resembles Netflix case study where our initial product offering is to allow entry
into the market, but is a small piece of a greater plan that will look very different

when realized

Economics Metrics Consumer price index

Managerial Finance Metrics Opportunity cost, annual reoccurring revenue (ARR)

New Venture Business Plan Business model canvas, cost of customer acquisition, lifetime value of a
Management Components customer, customer journey map, bootstrapping, accelerators, venture

capital, family & friends

Marketing Frameworks Customer go signals, breakeven analysis, brand association map

Marketing Strategy Frameworks Brand DNA, customer value priority segment

Negotiations Techniques Be prepared! I gathered intel by emailing the potential client and
inquiring what they want to see in the product presentation, which will
proceed the licensing negotiation. I consider the requested functionalities their
reservation to licenses.

It is my intention to use this plan as a marketing tool to attract investors and customers, so I welcome your
recommendations on how to streamline it appropriately for industry use.

Thank you for your guidance throughout this process.

Renee T. Williams, Ph.D.

BioTune ComputationsTM – Founder & CEO
[email protected]

COPYRIGHT 2019 © BIOTUNE COMPUTATIONS, LLC. ALL RIGHTS RESERVED

COPYRIGHT 2019 © BIOTUNE COMPUTATIONS, LLC. ALL RIGHTS RESERVED

BioTune
ComputationsTM
Business Plan.

SOFTWARE 05.2019
THAT WILL
REVOLUTIONIZE
THE WAY YOU
DO SCIENCE

BTC

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

business development.

08 15 Headlines

BUSINESS CANVAS MODEL MEET THE FOUNDER BioTune ComputationsTM
in talks with Amgen SSF
a snapshot of BioTune ComputationsTM Renee T. Williams, Ph.D. to license the OligoTune
MSPKTM platform for
22 43 pharmacokinetic studies.

PRODUCT MARKET FIT DEVELOPMENT TIMELINE Our founder was selected
to compete in the EMRG
oligonucleotide therapeutics OligoTuneTM suite of solutions Pitch-Off hosted by AWS
in Soho, New York,
November 23-24, 2019,
for a chance to win up to
$30K in cash and prizes.

Innovation is Our Profession. Founding Principle.

BioTune ComputationsTM will revolutionize the way you do science. “Innovation is limited only
Our modular approach to software development allows you to create by the level of our vision –
customized research solutions with functionality to meet your exact at BioTune ComputationsTM
needs. Our team of experts craft perfromance platforms with intuitive we strive to by a giraffe not
designs that delivery an exceptional customer experience. a turtle.“ #GiraffeVision

<<< i __________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019_______________________________________________________________________________________________________________________________________________________

table of contents.

About BioTune ComputationsTM 01 highlights

Leadership 13 Executive Summary

OligoTuneTM Suite of Solutions 19 03Page

Market Details 27

The BioTune Solution Interview with CEO

Executive Operations 37 17Page

Financial Projections 43 06Page

Appendix Product Specifications Marketing Strategy
A: Environmental Assessments
51

B: Market Survey Results 59 24Page 32Page

C: Marketing Frameworks 77 Strategic Map Startup Expenses

D: Proforma Statements 83 39Page 48Page

ii >>>__________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

biotune computations
01. introduction and
company summary

<<< 1 __________________________________________________________________________________________________________________________________________________________________________

01Business Plan 2019_______________________________________________________________________________________________________________________________________________________
Executive Summary
Introduction
Problem and Solution
Value Proposition
Business Description
Words from the Founder

2 >>>__________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

executive summary.

BioTune ComputationsTM was founded to revolutionize the drug discovery process one class of molecules at
a time. We are committed to crafting customized modular platforms that enable significantly shorter timelines
for moving a drug candidate from discovery to clinic. Our aim is to resolve one facet, of a multi-dimensional
problem, that drives up the cost of prescription drugs. Recognizing the value of this proposition, Amgen
initiated negotiations to license our pharmacokinetic (PK) module.

For software research tools within the pharmaceutical industry, the total addressable market (TAM) was
$28B in 2018. Our first suite of laboratory solutions, OligoTuneTM, were designed to support RNA-based
therapeutics, a field which saw $1.5B in total revenue last year. With an expected growth of 40% CAGR we
estimate a serviceable RNA software market of $108 M by 2022. Given we are poised to be best in class, and
leading substitutes include in-house programming, Excel spreadsheets, and non-secure web-based freeware,
we conservatively project a serviceable obtainable market (SOM) of $1.6M in 2020 with licensing, software
as a service (Saas), and subscription model. Notably, if RNA therapeutics live up to their recently demonstrated
potential, they could replace other classes of molecules, and be used for untreatable diseases, which would
completely reshape the industry landscape, significantly increasing the TAM, and in turn, our SOM for RNA
software.

Market research surveying 60 targeted end users from RNA-focused companies support our positioning
with 100% willingness to pay for the mass spectrometry (MS) solutions in the suite. We aim to capture market
share, establish a high barrier to entry, and achieve sustainable growth by securing Food & Drug Administration
(FDA) approval as a Drug Development Tool (DDT). A DDT designation will position our platforms globally as
an FDA recommended tool for specific use cases to generate findings for filing documentation require of every
molecule as it transitions from discovery into clinical trials and then to market. For added defensibility, we
filed a provisional patent around our MS-specific algorithm and their application in PK analysis.

We have exceptionally innovative solutions poised to generate healthy margins as well as social impact. As a
self-taught coder motivated to bring BioTune ComputationsTM to life, I have bootstrapped my vision into the
laboratory of one of the top pharmaceutical companies in the world. Now, we need your investment to go
global. We are raising $500K in seed capital to build a robust multi-user SaaS platform to house our modules
(60%), support international patent filings (10%), and hire a full-time research associate at a contract research
organization to expand the biology module (30%).

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Business Plan 2019_______________________________________________________________________________________________________________________________________________________

introduction.

Consumer Price Index for Digitizing Drug Discovery to Foster Pharmacoeconomic Performance
Pharmaceutical Drugs, 2018
The pharmaceutical industry is at a crossroads with expiring patents, lack of innovation
522.1 in the pipeline, plummeting research and development (R&D) productivity, and
increased pressure for pharmacoeconomic performance, especially in the United States.
Time to Bring a Drug from The challenge is that drug discovery is lengthy, expensive, and subject to high failure
R&D to Market, 2017 rates. Even with the greatest minds at the helm, only 1 out of 10 drug molecules ever
receives FDA approval. Given it can take up to 15 years and $2.6 billion to bring just one
5-15 yr drug to market, and an average internal investment of 15% of top line revenue is spend
on R&D ($116.4B by 2024 at 3.1% CAGR), the ROI in this industry is very poor by any set
of standards. Most decision making is done by human intellect, which is insufficient due
to the complexity of drug discovery. In fact, it is not uncommon to lack clarity around
the mechanism of action and other efficacy details for a drug molecule. Animal models
are incomplete in that they cannot perfectly predict outcomes in a human, which sorely
impacts clinical trials. There is significant loss in opportunity costs due to massive
failures in Phase III trials often attributed to poor efficacy.

Cost to Bring A Drug to Market In this competitive market where cost is a key driver, digitization enabled by anything-
plus 7% Opportunity Loss, 2018 as-a-service (XaaS), artificial intelligence (AI), and machine learning (ML) are the most
promising and disruptive technologies poised to relieve bottlenecks and streamline the
$2.6 B discovery and drug development process. R&D requires analysis of large data sets that
can now be leveraged at depth by AI-driven platforms to reveal correlations between
Pharmaceutical Spending per molecular entities and biological outcomes. AI can be further enhanced by ML to learn
Capita in United States, 2017 from past experiences to apply to future scenarios. AI and ML require significant
computing power that can be made possible through cloud-based access. Moreover,
$1,162 there is a significant opportunity for data network effects, particularly with ML-enabled
SaaS, to gain increased value with every additional user. Such platforms can greatly
derisk drug discovery, improve efficacy, accelerate the process, decrease R&D spend,
reduce drug prices, and make this industry accessible to emerging markets.

Artificial Intelligence Revolutionizing the Pharmaceutical Industry, Frost & Sullivan, D815-TV, October 2018
Emerging Technologies Energizing the Future of the Pharmaceutical Sector, Frost & Sullivan, D75A-TV, September 2016

Global Life Science Instrumentation and Research, Frost & Sullivan, K29D-55, October 2018
Innovations and Initiatives in AI for the Pharmaceuticals Industry, Frost & Sullivan, D835-TV, May 2018

Role of Artificial intelligence in drug discovery, Frost & Sullivan, D951-TV, February 2018
RNA Technologies enabling drug discovery, Frost & Sullivan, D86A-TV, December 2018

4 >>>_________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

problem and opportunity.

The rising cost of prescription drugs is a growing concern. There are several factors COST FACTORS
that contribute to this trend one of which is the spend on research and development.
Research & Development
In the laboratory, lack of computational resources is a problem. The science
advances with intellectual property, but the supporting tools fall behind. As a result, Increased Utilization
researchers are forced to create homemade solutions that were tedious to draft,
error-prone, wildly inconsistent, and prolong the entire R&D process. This has Rising Unit Cost
significant implications in that time to market is a critical component of a
multidimensional problem that drives up the cost of prescription drugs. Changes in Drug Mix

BioTune ComputationsTM was founded specifically to tackle this issue. Specialty Pharmaceuticals

Our end-to-end platforms are focused on calculating/predicating (bio)physical Timing for Generics
properties, mass spectral interpretation which is a severe pain point, and machine
learning to correlate outcomes with molecular design to expedite potential Anticompetitive Behaivor by
therapeutics from R&D to clinic. Manufacturers

Our flagship platform is the OligoTuneTM Suite of Solutions which supports ASO, Compensation of Stakeholders
RNAi, CRISPR and other nucleotide-based research. Given significant advances throughout Supply Chain
within the last year, including select FDA and EPA approvals, this field is projected to
grow at nearly 40% CAGR over the next five years. Coupled with the readiness of AI, PRESCRIPTION DRUG SPENDING IN THE U.S. HEALTH
ML, and soon quantum computing, BioTune ComputationsTM is well positioned to CARE SYSTEM: AN ACTUARIAL PERSPECTIVE
deliver best in class enterprise software solutions that will revolutionizes the drug ISSUE BRIEF MARCH 2018
discovery process.

Total Prescription Spending in the United States

Millions (USD) 700,000 699,517*
600,000
500,000 446,956
400,000
300,000 270,907
200,000 2010
100,000

0

2015 2020

Daemmrich and Mohanty Journal of Pharmaceutical Policy and Practice 2014, 7:9

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the BioTune solution.

BioTune ComputationsTM is a specifications, and then delivers a inconsistent, and impede the
software company that crafts customized solution. We are doing research process.
modular platforms to support the the same thing, but with software, to
end-to-end computations needs for create highly personalized tools for OligoTuneTM, our flagship platform,
research laboratories – one class of scientists to streamline their entire supports ASO, RNAi, and other
molecules at a time. workflow. nucleotide-based research. Whether
you are calculating something
You may liken us to an instrument Our modules replace homemade routine like molecular weight or
company that allows its customers to solutions, Excel files, and other performing more advanced
select desired features from a list of manual computations, which are computations like mass spectral
offerings, builds the unit to tedious to draft, error-prone, wildly anaysis we have a module that is fast,
easy, and secure to meet your needs.

6 >>>_________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

value proposition.

BioTune ComputationsTM is for research
scientists who want to streamline their
laboratory practices. We offer customized
modular software designed to promote
efficiency in the workflow.

Unlike our competitors, we resolve your
computational needs into a single
platform that can be tuned to support an
array of intellectual property. Built
upon more than a decade of experience at
the bench, our solutions allow for flexible,
confidential, ease of use and are
protected by our commitment to
providing superior customer service.

Our vision is to be the leading seller in
laboratory computational tools. We work
to fulfill this vision by crafting the most
versatile products on the market. We are
focused on achieving brand recognition
and substantial growth with the launch of
our flagship platform, OligoTuneTM, by
integrating it into industry and academic
laboratories across the globe.

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business canvas model.

KEY PARTNERS KEY ACTIVITIES VALUE PROPOSITION RELATIONSHIPS SEGMENTS

Chemical and Platform Single Platform in lieu Presentations and Research Labs
instrument development and of accessing multiple demonstrations at
manufacturers maintenance resources molecule specific Pharma: reduce R&D
Securing conferences time and cost;
Cloud provider Alpha/beta testers Customizable minimize human
Licensing partners modules that offer Free web- error; standardize
Investors Marketing and ads exactly what you need subscription for trial procedures
Generating period
Research laboratory proprietary User friendly with low CRO: quicker turn
nucleotide data learning curve Twitter, LinkedIn around with less
Software development Securing investors groups, Instagram manpower allows for
team Supports IP to (social media) more projects, and
KEY RESOURCES minimize need for increased margins
Tech platform homemade solutions Retain with
Sales reps superior customer Academia: minimize
Brand Expedite research service the effect of high
Users to build data process to minimize turnover rates and
network effect time to market CHANNELS provide a resource
Marketing team for students to
Secure to protect IP Direct sales through benchmark their
website/sale rep learning
Unlike our
competitors, we Distribution
resolve your partners
computational needs (influencers) that
into a single platform already exist in
that can be tuned to customer's
support an array of purchasing routine
intellectual property
Scientific meetings
that target
demographic

COST STRUCTURE REVENUE STREAMS TEAM

Employee payroll Licensing: executable for basic modules Renee Williams Ph.D. – Founder, CEO
Legal fees SaaS: AI- & ML-enhanced computing Contractors
Marketing Subscription: simplified platform for
Tech platform costs academia only

SOCIAL & ENVIRONMENTAL COST SOCIAL & ENVIRONMENTAL BENEFIT

Servers generate excess heat which requires constant Minimize time to market for potential therapeutics which is
cooling. Both adversely affect the environment. critical factor of a multidimensional problem that drives up
the cost of prescription drugs.

8 >>>_________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

business description.

The business idea

BioTune ComputationsTM is a software company that crafts modular platforms to
streamline the end-to-end computational needs for research laboratories – one
class of molecules at a time.

The business idea

BioTune ComputationsTM was founded to revolutionize
the drug discovery process one class of molecules at a
time. We are committed to crafting customized
modular platforms that enable significantly shorter
timelines for moving a drug candidate from discovery to
clinic. Our aim is to resolve one facet, of a multi-
dimensional problem, that drives up the cost of
prescription drugs. Ultimately, we work to develop
highly efficent workflows that enable drug discovery to
develop in emerging markets.

Regulatory Affairs Trademarks & Patents

There are no regulatory requirements for the A provisional patent and trademark are in draft with
OligoTuneTM platform. Cedric A. Hue, JD Ph.D. of D’Hue Law LLC in West
Lafayette, Indiana.
It is our aim to recieve a Drug Development Tool
(DDT) designation from the Food and Drug All data presented herein is the sole property of BioTune
Administration (FDA) for the OligoTune MSPKTM ComputationsTM.
module for its automated data analysis outputs to
be included in investigatinal new drug (IND) filings.

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Business Plan 2019_______________________________________________________________________________________________________________________________________________________

the steps to market success.

We are committed to crafting customer-centered solutions that
resolve severe pain points and anticipate future needs

Fast Flexible

Significantly reduce end-to- Support intellectual property by
end data analysis time for a making it easy to include
given workflow molecular modifications

Secure Accurate

Instill confidence that our cloud- Generate results equivalent to or
based platforms are secure more accurate than currently
available methods
Scalable
Education
Capable of meeting the data
demands for any size company Inform industry on the capabilities of
artificial intelligence and machine
learning

10 >>>_________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

words of the founder.

Distance Traveled

I used to think once I earned my Ph.D., finished my
postdoc, and landed a coveted laboratory
position at a top pharmaceutical company, my

“I am not crazy. I am an entrepreneur. I am
supposed to wake up in the morning and see a
world that others cannot envision.”

science life would be made. It turns out that I had
no joy because I was living someone else’s dream.
When I learned to embrace my uniqueness and the
notion that there is something in this world that
only I can do, BioTune ComputationsTM was born as
a beautiful expression of self. I realized that my
decade of experience in a niche field makes me an
expert with an unparalleled advantage over any
other founders. In addition to knowing what
researchers want, I have the intellectual capacity to
design it and the courage to bring it to life.

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Business Plan 2019_______________________________________________________________________________________________________________________________________________________

“ Innovation is limited only by our level of vision – at

BioTune Computations we strive to be a giraffe not a turtle.



- Founding Principle, November 23, 2018
#GiraffeVision

12 >>>_________________________________________________________________________________________________________________________________________________________________________

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biotune computations
02. leadership &
company structure

<<< 13 _________________________________________________________________________________________________________________________________________________________________________

02Business Plan 2019_______________________________________________________________________________________________________________________________________________________
Meet the Founder
Advisors and Contractors
Interview with the CEO
Company Structure

14 >>>_________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

meet the founder

self-taught coder to create BTC

Founder & CEO Subject Matter Expert
MBA Ph.D. in Chemistry

<<< 15 _________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019_______________________________________________________________________________________________________________________________________________________

advisors and contractors.

Wanda Williams Louis Gavino Elspeth Murray, Ph.D.

financial advisor sales advisor venturing advisor

Financial Partners Credit Union Thermo Fisher Scientific Queens University
Chief Administration Officer Senior Sales Manager Smith School of Business
$1.3B in assets, 14 branches Technical CapEx - 10+ years Professor and Associate Dean
Pepperdine University - MBA 7 years bench experience Centre for Business Venturing

Brandon Harris Janae Grijalva Geaux Strategies & Technologies

marketing advisor operations advisor strategy management firm

PenFed Credit Union McKinsey & Company Innovation agency that develops
VP of Digital and Innovation Engagement Manager tactics to align & engage investors
Head of Marketing Harvard University - MBA and entrepreneurs through R&D,
Cornell University - MBA Stanford University - Economics Commercialization, and Strategy

16 >>>_________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

interview with our ceo.

read more. What was your motivation for starting What are you currently excited about?
BioTune Computations?
This is an amazing time to support the
My initial reasons for starting this pharmaceutical industry. Previously,
company were selfish. I was fed up with there was strong resistance to change so
the inefficiencies in my daily work flow. I the BTC value proposition would not have
loathed the tedious manual calculations I been possible. But, given the push for
had to do before I could complete my real pharmacoeconomic performance and the
tasks. I also found it impossible to deliver steep decline in R&D productivity, the
desired mass spectral analysis in a timely industry is primed for change. Coupled
fashion because I was annotating by with an abundance of data, and
hand. So I spent a year teaching myself advances in cloud , AI, and ML
to code to write scripts to make my life technologies it is the ideal combination
easier. Then I thought that others may of need and capabilities. We are
appreciate my applications. But, when I excited to be at the forefront of
took myself out of the equation, I realized this scientific revolution.
I had an opportunity to make significant
social impact by streamlining the How can people learn more?
research laboratory to help lower the cost
of prescrition drugs and enable drug Renee-Therese-Williams
discovery laboratories in emerging BioTune-Computations
market. This is why I continue to do what
I do. @BioTuneC
@ReneeTheChemist
What makes your company different?
BioTuneComputations
Because researchers are the most ReneeWilliams-Chemist
important asset in the drug discovery
process, BTC is laser focused on building biotunecomputations.com
tools customized to support their exact
needs. We take a personalized approach BioTune-Computations
to developing a highly effiecent, cloud-
enabled laboratory experience. Renee-Williams
@biotunecomputations.com

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company structure.

Act. Learn. Adapt. Innovate.
is a tenet of the organizational culture

that informs our decisions towards
realizing the company vision

Our Vision Our Mission

We strive to be the leading BioTune ComputationsTM is focused
seller in research laboratory on innovating the most versatile
computational tools. research computational tools on the
market.

We are committed to crafting
customer-centered solutions that
resolve today‘s challenges and
anticipates future needs.

Our team of experts work to achieve
brand recognition and substantial
growth by integrating OligoTuneTM,
our flagship platform, into industry
and academic laboratories across the
globe.

18 >>>_________________________________________________________________________________________________________________________________________________________________________

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biotune computations
03. company details &
our products

<<< 19 _________________________________________________________________________________________________________________________________________________________________________

03Business Plan 2019_______________________________________________________________________________________________________________________________________________________
SWOT Analysis
Product Pricing
Specifications
Case Study

20 >>>_________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

swot analysis.

SWO T

Founded on more Incomplete team Premier platform Poor adoption of
than a decade to secure entry into in every research cloud services due
of laboratory top accelerators or and development
experience to data security
venture capital laboratory concerns
investment

Strength Weakness Opportunities Threats

Market research Self funded with a weak Poised to calipalize on Fading interest in RNA-
overwhelmingly supports cash position. current market interest in based therapuetics if

product need in the Do not have key team ASO, RNAi, and CRISPR clinical trials fail.
pharmacuetical space. members in place nor technologies.
insufficent means to Low customer
There are few direct Capture long-term conversion from
competitors or scale. market share by securing homemade solutions
Drug Development Tool
commercial substitutes Initial product faces a Well-established vendor
niche market. approval from FDA for releases similar line of
Creating best in class OligoTune MSPK
product products first
inclusion in IND filings.

<<< 21 _________________________________________________________________________________________________________________________________________________________________________

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ripped from the headlines…

OligoTuneTM was selected as the flagship platform based on
product market fit evident by the recent success of oligonucleotide
therapeutics, their potential to completely reshape the pharmaceutical

landscape, and the expertise of our leadership

22 >>>_________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

product pricing.

OligoTune Basic TM Supports modifications Experimental values

$8,000 Daily Calculations Text to structure

Single license pricing. Executabe sold per licences. Supports routine computations in RNAi,
ASO, and CRISPR workflows. Can be used to generate certificate of
analysis or custom reports for registration of molecules on internal
database.

OligoTune MSPK TM Peak picks raw MS data Metabolite identification

$100,000 Calculates PK parameters AI-enabled data analysis

Customization and installation. A SaaS module crafted specifically for mass spectrometry-based
pharmacokinetic analysis of oligonucleotides. Can be used
$5,000 quantitatively or for metabolite identification. This module is
accessable through the basic executable.
Monthly service after 1-year.

OligoTune EDU TM Open access Flexible inputs

$5,000 Lean functionality Fix reporting

Annual subscription. A web based subscription only available to academic laboratories.

<<< 23 _________________________________________________________________________________________________________________________________________________________________________

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product specifications.

OligoTune Basic TM Basic Oligonucleotide Module

Customize to include your Molecular Weight CSV Upload BatchProcessing
intellectual property.
Composition Unit Converter Melting Temperature
OligoTune MSPK TM
Custom Extinction Sequence Generator
Calculates PK parameters Reporting Coefficent
in minutes.
OligoTune Basic supports routine computational needs in a ASO and RNAi
work flow including base, sugar, and backbone modifications.

MS-based Pharmacokinetic Module

1- and 2- MS Spectral Metabolite ID &
Compartment Analysis Quantification

Exposure Half-life Clearance

AI-enabled data Area Under Elimination
interpretation the Curve Constant

OligoTune MSPK may be used qualitatively for metabolite ID, or quantitatively to
generate PK parameters for time- and dose-dependent studies.

OligoTune EDU TM Academic Platform

Only available to academic Molecular Weight Unit Converter Composition
laboratories.
Complementary Fixed Extinction
Sequence Reporting Coefficient

OligoTune EDU is a lean web version of OligoTune Basic.

24 >>>_________________________________________________________________________________________________________________________________________________________________________

Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

case study.

The Challenge. The Solution.

Mass spectral analysis for the identifacation and OligoTune MSPK TM peak picks the target analyte and
quantification of oligonucleotide metabolites, its metabolites from raw mass spectral data,
especially pharmacophores, to determine quantifies, and plot relative a calibration curve. That
pharmacokinetic parameters. data is used to calculate PK parameters such as
maximum exposure (Cmax) , time to Cmax (Tmax), area
Background. under the curve (AUC), elimination rate constant
(kel), and half-life (t1/2) using a 1- or 2-compartment
Pharmacokinetics (PK) is a branch of pharmacology method. These parameters can be linked to efficacy
focused on the absorption, distribution, studies for AI-enabled analysis.
metabolism, and excretion of substances
administered to a living organism. In the case of a
pharmaceutical drug, PK is the study of how the
organism (i.e. animal, human) affects a drug
molecule.

PK parameters are necessary to describe variability
and dose-response correlations of a drug molecule
in the evaluation of safety, efficacy, and quality
performed, all of which are important for
individualized treatment, and thus, therapeutic
relevance.

Before a drug molecule can move out of the
discovery and screening phase into clinical trials, an
investigational new drug (IND) application must
be filed with the Food and Drug Administration
(FDA). The FDA requires a PK summary to be
included in the IND application.

Currently, the FDA protocol for generating PK data
for IND filings describes a semi-manual process
that is time consuming and often incomplete.

OligoTune MSPKTM standardizes this otherwise
subjective process, and reduces time for data
analysis down to seconds.

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pharmacokinetic analysis of siRNA

CCoommpparairsiosonnoof Mf Metehthooddoolologigeises

4 hr
26 hr
122 hr

Project Description.

OligoTune MSPK TM was validated against traditional methods
using the data collected in triplcate for PK studies conducted
with C57BL/6 mice. Acquision of mass spectra and “Manual
Process“ calculations were completed by a contract research
organization. Those same spectra were then subjected to
OligoTune MSPK TM algorithms to calculate comparable data.
The software was coded by and is the sole property of the
BioTune Computations TM LLC.

Project Date June 2017
26 >>>_________________________________________________________________________________________________________________________________________________________________________

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biotune computations
04. target market &
competitors

<<< 27 _________________________________________________________________________________________________________________________________________________________________________

04Business Plan 2019_______________________________________________________________________________________________________________________________________________________
Target Market
Competitive Analysis
Market Research
Marketing Strategy
Marketing Plan

28 >>>_________________________________________________________________________________________________________________________________________________________________________

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target market.

Geographic Firmographic

Soft launch of OligoTune MSPKTM will focus on Soft launch will target RNA-based labortories with
pharmaceutical, academic, and contract research pharmacokinetic groups focused on ASO and RNAi
laboratories within the contenintal US, but full launch technologies. Full launch will expand to complete RNA
will be global. programs including CRISPR.

Psychographic Behavioral

Initiators, users, influencers, and decision makers in a Start-up pharmacuetical laboratories with ample
laboratory, who are often the same person – the investor capital and minimal in-house capabilities.
researcher.

<<< 29n_m___a__k__e_r__i_n__t_h__e___b_u__y__i_n_g___c_e__n__t_e__r_.__I_n__a___la__b__o__r_a__t_o__r_y_____________________________________________________________________________________________________________
environment they may be all be the same person – the
researcher.

Business Plan 2019_______________________________________________________________________________________________________________________________________________________

market & competitive analysis.

$46.5 B $1.7 B $17.4 M The Competitive
Advantage.
TAM SAM SOM
Unlike our competitors, we resolve
scientific software spend in scientific softwre spend based on 2024 projection of market your computational needs into a
the pharmacuetical industry ASO, RNAi, and CRISPR revenue share of RNA-based software single platform that can be tuned to
2024 projection at 4% CAGR support an array of intellectual
2024 projection at 40% CAGR SOM will grow as product line property.
2% of top line revenue expands to include addition
SAM will grow as product line
expands to addition molecules molecule platforms

Competitors OligoTuneTM Promass Freeware Homemade LIMS
Supports IP

Facilitates PK Studies
Mass Spectral Analysis
(Bio)physical Properties
Flexible Configuration

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market research. Product Quality: 85%

Trends of the Market Quality and Reliability (83%) were randked highest as Product
Details “Quite Important“ to the decision making process for
Healthcare is shifting towards precision medicine. buyers. Only 55% of respondents were concerned with
This requires an acceleration of the drug discovery Competitive Pricing.
process at a lower cost from bench to bedside.
Past Experience: 63%

Past Experience and Technical Support (54%) were ranked
highest as Company Details “Quite Important“ to the decision
making process for buyers.

1. End-to-end solutions. Journal Articles: 43%
2. X-as-a-Service.
3. Artificial intelligence. Journal Articles, Articles in Magazines (41%), and Internet
4. Cybersecurity. Searches (40%) are the preferred methods for discovering new
products and technologies that Drive Scientist to Buy.
Source: Frost & Sullivan, D75A-TV, September 2016
Source: C&EN Media Group, 2019 Media Kit (cenmediakit.org)

Customer Segmentation Needs of the Market

Market Pharma Just as one drug does not fit all, neither does one platform.
Academia Every class of molecule has unique computational
Government requirements. When polled, oligonucleotide scientist
CRO expressed the following needs to relieve their pain points:
Non-Profits
"Software enabling advanced customization is very useful. Easy
OligoTuneTM, the flagship platform, will primarily integration with AI tools/packages would be helpful.“
target pharmacuetical companies , contract
research organizations (CRO), and academia. "Software enabling easy daily calculations such as molecular
weight and extinction coefficient for modified oligos.“

"Connected interface with biological data.“

"Embedded conversions (mg/mL to molarity and vice versa).“

"Sequencing prediction software of oligonucleotides with
backboane or site specific modifications.“

"Something related to LC-MS analysis of ODN.“

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marketing strategy.

01 02 03 04

Conferences Journals & Magazines Social Media & Digital Influencers

Podium talks, poster Cite BioTune ComputationsTM in Build an inbound following and foster Co-market with influential
presentations, and vendor peer-reviewed articles that leverage engagement on Twitter, Instagram, vendors as means of
boothes highlighting use the platform. LinkedIn. validation and to reach a
cases, case studies, and larger targeted audience.
live demonstrations . Advertisements in C&EN and similar Presence on blogs and other digital
scientific magazines. forums to strengthen SEO and drive
traffic to website

Word of Mounth: 27% Offline Marketing Analysis.
Conferences: 32%
Speaking engagements and demonstrations at customer-rich conferences and events
coupled with word of mouth advertising remains a tried and true method of offline
marketing for scientific products. It leaves a lasting impression on potential customers that
is difficult to replicate through other channels.

Influencer marketing is trending towards nano followings in well define sector. For
OligoTuneTM solutions, companies like Zymo, Miltenyi Biotec, GlenResearch, and others that
share the same nucleotide customer base, but have non-competing, or even complementary
value propositions are ideal partnerships.

Journal/Magazine: 43% Digital Marketing Analysis.

Internet Search: 40% Online journal and magazine articles are the #1 digital vehicles to drive scientists to buy new
products and technologies. The “Materials and Methods“ section serve as a shopping list that
Source: C&EN Media Group, is often replicated from one reader to the next.
2019 Media Kit (cenmediakit.org)
Social media has revolutionized digital marketing. Given the #2 driver for scientist to buy is
based on internet searchers, strong social media and overall digital presence is important for
search engine optimization to drive potential customers to our products.

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marketing plan 01 - conferences.

Podium Talks Poster Presentations Vendor Booths

Detail use cases and case Provide broad scope of the Hands-on demonstrations to
studies while highlighting platform in its totality. show ease of use and overall
current adopters. value proposition.
Allows for granular
Demonstrate subject conversations about each Collect contact information
matter expertise by platform module. for targeted marketing
fielding technical campaigns.
questions. Interact 1-on-1 with a high
volume of potential users. Make sales in real-time.
Build rapport with
potential customers.

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marketing plan 02 - journals and magazines.

Collaboration.

Collaborate with
laboratories to publish
work that utilized BTC
platform.

technology.

Publish articles in
technology magazines
to showcase the
module capabilities.

Last update: May 2019

+62 % 38 %

Ad Ut lab ipide Ad Ut lab ipide
omnia vellam omnia vellam

“In a world dominated by digital content customers are rediscovering
the value of tangible, turnable pages over other forms of media.”

-Association of Magazine Media, 2018

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Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

marketing plan 03 - social media.

Trending Beyond 2019

Social media marketing is trending away from a text-first approach towards a
visual-first mentality. Investing in newer mediums such as Stories and Live
Streaming, as well as more traditional photos and videos to create inbound
content is necessary to engage an audience in our brand experience.

Brand Mediums Technology
Authenticity Stories AI-driven engagement
Transparency
Privacy Live Streaming Personalization of
Videos customer experience
Source: Smart Insights (www.smartinsights.com) Photos
Podcasts

WhatsApp Twitter Instagram LinkedIn

Business app has quickly With a focus on “look what I Authenticity is key. “Going Live“ Demonstrate founder

become the primary social see,“ it is the ideal platform is a powerful tool to engage an expertise, educate on

customer service channel to release product launch audience and strengthen the brand history, share journal

allowing free responses announcements, new relationship between brand and publications, and other

within 24 hr, promoting partnerships, details for followers. technical communications

customer centric brands. hosted event, and other Broadcasting long-form vertical to millions of targeted
breaking news. videos on IGTV supports senior-level influencers
content such as “how to“ videos and decision makers.
tet id qui utempor esequis on demand.
evelesc iaecabor re,

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Business Plan 2019_______________________________________________________________________________________________________________________________________________________

marketing plan 04 - influencers.

Nucleotide Specific Vendors with Dedicated Customer Base

Starting Material Consumables Instrumentation

Foundational Influencers Sample Influencers Analytical Influencers

Irrespective of the use case for an Whether one is working with synthetic Mass spectrometry is an invaluable tool

oligonucleotide all research begins with the material or biological extracts, sample in oligonucleotide research. Nearly

starting material. Partnering with vendors preparation and clean-up is built into every laboratory leverages its

such as ChemGenes, Glen Research, and every workflow. Aligning with partners capabilities at least once in their

Biosearch Technologies is an excellent way such as Zymo Research, Miltenyi Biotec, workflow. Having our products offered

to engage our customers at the beginning and Bechman who focus on making through instrument catalogues is great

of their research journey. single-use products specifically for this exposure for BTC and allows our

case is ideal to ensure repeated touch partners to differentiate to an

points with our target market. oligonucleotide specific audience.

consumables are reorder.
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biotune computations
05. strategic &
executive operation
Plans

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05Business Plan 2019_______________________________________________________________________________________________________________________________________________________
Strategic Map
Operating Plan
Product Timeline

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strategic map

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Business Plan 2019_______________________________________________________________________________________________________________________________________________________

from vision to action.

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Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

operational plan.

Our opertional plan is focused on launching OligoTune MSPKTM in the coming 6-12 months. Action items address software
development, traction and fund rasing through licensing, defensibility, and visability in support of a #JFLA philosophy.

Operational Time Plan the BioTune advantage.
>> Quality Products
Development Ongoing End: 2019 >> Flexible Modular Configuration
Fundraising 30 to 120 days End: 2019 >> Premium Customer Experience
Visibility 60 to 90 days End: 2019 >> Innovative Technology
Defensibility 60 to 120 days End: 2020
Traction 90 to 180 days

Project Action Operation Executive Project Manager

Development Expand PK functionality Contractor Renee Williams
Raise Capital CEO, CMO Renee Williams
Visibility Family & friends campaign,
Defensibility compete in pitch contests, CMO Renee Williams
Traction apply for NSF SBIR grant
Cedric A. Hue, JD Ph.D. Micheal Cato
Website and social media of D’Hue Law Renee Williams
content creation and
maintanance CEO Renee Williams

File provisional patent &
trademark applications;
Start FDA DDT process;
Secure release from J&J

Secure licensing agreement
with 1-2 local laboratories

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Business Plan 2019_______________________________________________________________________________________________________________________________________________________

key milestones.

“Sometimes your best will not be enough. You must be
willing to do what is necessary.” – Renwick Payne

Proof of Concept Executive Training Builing a Team

Ideation began in 2017, but I In July 2018, our founder enrolled In January 2019, Geuax Stratagies
didn’t have the programming in an MBA program to receive a and Technologies came on board
skills to bring it to life. formal and applied education in to assist with drafing and filing
business principles and provisional patent and trademark
I spent the next year teaching entreprenuership. applications. BTC also leverages
myself to code and testing it their software development team
against laboratory data. With the combination of subject to turn proof of concept into a
matter expertise, growing MVP.
Founded BTC in November 2018 business acumen, and broad
alumni network, BTC has Actively searching for a CTO, COO,
formidable leadership and is and vetting a CMO.
primed for success.

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Business Plan 2019 _______________________________________________________________________________________________________________________________________________________

product development timeline.

01 // 02 //

Ideation and Lead Selection, Development,

Proof of Concept and Soft Launch

2017 Q4 2018 Q2 2019 Q4 2019

Proof of Concept Lead Module Soft Launch

Enterprise Software OligoTune MSPKTM Licensing Agreements

To create a modular Surveyed 300+ nucleotide researchers Establish OligoTune MSPKTM

platform that can be targeted on LinkedIn (60 respondents) licensing agreements with

customized to support to discovery their primary pain point is local laboratoies to further

the entire workflow for around mass spectral anaysis. These validate software, increase

an oligonucleotide insights led to focused development of functionality, and use data

laboratory. OligoTune MSPKTM as the foundation to support FDA Drug

of the BTC market entry strategy. Development Tool

application.

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Business Plan 2019_______________________________________________________________________________________________________________________________________________________

03 // 04 //

Infrastructure , Platform Full Launch – OligoTune
Refinement, and Soft Launch Suite of Solutions

and Testing

Q1 2020 Q3 2020 Q1 2021 Q3 2021

Infrastructure Platform Refinement Full Launch

Server, SaaS, & ML Connected Modules OligoTuneTM Suite of Solutions

Transfer OligoTune Finish building out the synthesis, (bio)physical, Roll out the complete suite of
MSPKTM to third-party mass spectral, CRISPR , and manufacturing solutions targeting
server and build modules, and ensure they are syncronized for a pharmacuetical laboratories,
infrustructure to securely connected experience. Soft launch select contract research organizations,
leverage data network modules through the website and invite private institutes, and academia.
effects of ML-enabled pharmaceutical and academic laboratories to a
SaaS. free-trail in exchange for feedback.

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biotune computations
06. financial forecasts &
fundraising

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