Specialty pharma and car t advisors 1[1]

Harrison Hayes. The Global Leader in Niche Life Science Strategic Corporate Development.
Specialty Pharmaceutical + CAR-T
Micro-Niche M&AAdvisors

Harrison Hayes is a unique, life science-
focused, strategic research and advisory
services consultancy.
Our strength lies in a network of selective
clientele and an aggressive research team
committed to staying abreast of the latest
advances, trends and evolving corporate
strategies.
Actively maintaining relationships with an
international network of leading business
development, R&D, licensing professionals,
technology transfer centers, and venture
capital firms provides Harrison Hayes with the
resources necessary to uncover the most
promising and thorough deliverables for our
clients.
About Harrison Hayes

Harrison Hayes Represented
Morphosys in the Identification
and Acquisition of Lanthio
Pharma
Juno Therapeutics in the
Identification and Acquisition of
Stage Cell Therapeutics
creden&als


Celgene in the Identification and
Acquisition of Quanticel
Pharmaceuticals
Merck Serono in the
Identification, Negotiation and
Closing of the Licensing
Agreement with Intrexon
creden&als


Orphanetics in the Securitization
of $65MM in Private Financing.
Harrison Hayes Secured an
Undisclosed Round of Financing
in a Private Placement for
BioArbitrage Fund IV
Orphanetics is an orphan drug
accelerator focused on developing
and delivering life-transforming
therapies for patients with severe and
life-threatening rare diseases.
Orphanetics is privately funded by
public and private investors from the
pharmaceutical, life sciences and
global healthcare community.
bioarbitrage
The BioArbitrage Fund acquires early
stage assets (compounds), then quickly
repackages and embellishes the asset for
divestiture.
The fund amplifies the ROI prior to
‘flipping the asset’ (divesting) to an
acquirer.
creden&als


Avant in the Identification and
in-Licensing Transaction for
CDX-1135 from Johns Hopkins
Tech Transfer resulting in a Net
Fund Gain of $2,221,000
Forest Labs in the Identification
and Licensing Transaction for
U.S. Rights to Nycomed’s PDE-4
Inhibitor Daxas Resulting in a
net Fund Gain of $1,400,000
Plus Royalties
creden&als

Harrison Hayes SymBio in its
Divestiture to PerkinElmer
Generating a net Fund Gain of
$3,241,000
Rib-X in the Identification and
in-Licensing Transaction for
Delafoxicin (Phase II) from Yale
University Resulting in a Net
Fund gain of $875,000 Plus
Milestone and Royalty Payments
creden&als

Duramed (A Subsidiary of Barr
Pharmaceuticals) in Their
Acquisition of FEI
Adiana in its Divestiture to Cytyc
For a Net Fund Gain of
$1,115,000
creden&als


Serono/InterLab in the
Identification and In-Licensing
Transaction of Rebif (Frone)
from The Weizmann Institute of
Science Which resulted in a Net
Fund Gain of $2,300,000 To Date
Harrison Hayes was Engaged by
Dalian Medical University
(China) to conduct a Portfolio
Analysis and Strategy Assessment
of its Life Science Intellectual
Property Assets
creden&als


Anteo Diagnostics in its
Licensing Agreement with
Malaysian based DioSion
Diagnostics. This Transaction
Represented a Net Fund Gain of
$980,000 Plus Future
Consideration
Imaxio in the Identification and
Negotiation of its Vaccine
Licensing Agreement with Isis,
the Technology Transfer Arm of
Oxford University. This
Transaction Represented a Net
Fund Gain of $1,900,000
creden&als


ECoDU™

ECoDU™
ExternalCorporateDevelopmentUnit

There are numerous reasons why companies should seek to establish an External
Corporate Development Unit.
An ECoDU:
Why…
Create An External Corporate Development Unit (ECoDU™)?
Why seek to establish a
External Corporate
Development Unit
(ECoDU™)?
Provides an open model for corporate
development innovation through ideation
ontologies focused on the future strategy of the
organization.
Assists in the scaling up of global opportunity
analysis including “off the radar” acquisition
opportunities: Transforium™.
Provides flexibility for existing internal CorpDev
staff to move seamlessly into dealtracking,
strategic planning, negotiations and
opportunity sourcing on demand.
Companies with an External Corporate
Development Unit out-perform those who do not.
ECoDU™

Setting Up an External Corporate Development Unit (ECoDU™)
The life science corporate development experts at Harrison Hayes will work with you to craft
the ideal model that aligns all internal stakeholder corporate strategy mandates to ensure a
fluid, effective outcome.
Success
Visionary
Senior
Executive
Committed
Resources
Governing
Mechanism
Human
Capital
Project Transfer
Process
ECoDU™

Vetting Process
Joint Business Development
Licensing in
Venturing
Licensing
out
R&D services
DivestmentsSpin
out
Spin in
Acquisitions
Deal
Ve0ng

Transforium™
The Transforium™ database is unique and proprietary to the Harrison Hayes. Transforium™
houses over three million (3,000,000) early stage compounds, technologies, and assets
across a multitude of indications. Indications of assets in Transforium™ include:
Indications
of assets in
Transforium™
Cancer; specific focus on
pancreatic, ovarian,
glioblastoma, liver,
lymphoma and melanoma
Huntington’s Disease
Cystic Fibrosis
Hemophilia
Asperger Syndrome
ALS
and many
more
Diabete (type 1 and type 2)
Arthritis
Pulmonary conditions such as
COPD and Pulmonary Fibrosis
Alzheimer’s
Chonic pain
Of the 3,000,000 opportunities within Transforium™, roughly twenty-five percent (25%) are not in
the public domain and are unique to Harrison Hayes. This offers our partners first rights to these
potentially lucrative opportunities.
Transforium™

Transforium Scouting Tool
Technology Sourcing includes the identiﬁcation of technology developments and the facilitation of
the
sourcing of technology.
Provisioning of Technology
Intelligence to Facilitate the
Technology Management
Building and Using a Network of
Experts for Competitive Advantage
Scouts Facilitate the Sourcing
of Technology
Acquisition, Development,
Storage, Usage and Selling of
Technological Knowledge
Identiﬁcaiton, Assessment
and Usage of Information on
Technological Development
Scouts Identify and Assess
New Technology
Technology
Intelligence
Technology
Scouting
Technology
Management
Transforium™

Key Innovation Leaders
In order to best assess future value and
build an appropriate, futuristic business
case for the target opportunity, we may
engage a select group of Key Innovation
Leaders (KILs).
Key Innovation Leaders (KILs) are
recognized as the foremost experts
and “futurists” in their respective
fields.
Our proprietary panel of cross-
disciplinary KILs look at the future
market trends ten (10) to twenty (years)
from the present day.
Because KILs are on the cutting edge of
trends, they function as a valuable
resource for understanding the future of
the business, new business models,
products and platforms including policy,
regulatory, technology, customer
conversion, technology adoption, and
risk aversion, and for understanding real-
world market evaluation and assessment.
Researchers and Academic
Researchers
Private Equity Group
Executives
Regulatory and
Reimbursement Experts
Serial Entrepreneurs
Technology Transfer Center
Executives
Industry and Market Sea
Changers
Examples of Key
Innovation Leaders
KILs(KeyInnovationLeaders

PIPV Tool
PIPV™ is a proprietary analysis that serves as a method of maximizing value of identified
intellectual property. The PIPV™ provides a comprehensive assessment, quantifying the
value of a technology or compound and identifying the requirements necessary for
commercial success.
The PIPV™ analysis serves to:
Provide important market
and competitive analysis
Estimate the likelihood of
FDA approval
Assess patents and their
legal defensibility
Perform valuations on
individual compounds or
entire pipelines
PIPV™PredictiveIntellectualPropertyValuation

There are five (5) components of the PIPV™ analysis:
•  Commercial Analysis
•  Scientific Analysis
•  Legal Analysis
•  Financial Analysis
•  Feasibility Analysis
PIPV™

PIPV Tool

PIPV Tool - Commercial Analysis
The commercial analysis focuses on identifying major hurdles to commercial success. This
research is designed to ensure that the identified asset’s value will be maximized to the fund
and potential acquirers. The commercial analysis examines:
Commercial
Analysis
Key research and market
data
Existing and potential
competitors
Market comparable transactions-including
financings,
collaborations and alliances
PIPV™

PIPV Tool - Legal Analysis
The purpose of legal analysis is to evaluate the overall patent and legal viability of the assets.
We will:
Legal
Analysis
Investigate all relevant patent
initiatives
Assess legal
defensibility
Determine overall strength and scope of intellectual
property rights
PIPV™

PIPV Tool - Financial Analysis
Here, we utilize our financial acumen to accurately assess the strike price of potential assets
and value of optioned assets. To do this, we:
Identify market
comparables
Perform quantitative
analysis
Financial
Analysis
Assist in development of pro forma financial
statements
Calculate “burn rate” and other financial projections
Develop schedules and timelines for product
development
PIPV™

PIPV Tool - Feasibility Analysis
The feasibility analysis is our opinion on the feasibility of the compound to reach
commercialization based on:
Feasibility
Analysis
Experience and track record of management
team
Development progress and
timelines
Competitive and substitute
analysis
Potential exit
strategies
PIPV™

PIPV Tool - Scientific Analysis
The scientific analysis provides our own evaluation of the optioned asset. This assessment
includes items such as:
The method of action
The target compared to the current standard of care
Scientific
Analysis
The target compared to other treatments under
development
Identify key competitive
strengths
PIPV™

CAR-‐T

Brand
Percep&on
and
Posi&oning
Study

CAR-T:
Market Perspectives
April 15, 2015
Brand Acumen + Harrison Hayes

CAR-T: Market Positioning
31

The purpose of this presentation is
to examine the CAR-T market
landscape with an eye on brand
positioning, market messaging and
current external perceptions.
The contents include a high level
overview of the nomenclature and
nascent brand architecture of the
primary companies, a review of the
evolving CAR-T lexicon, and the
results of a CAR-T specific Brand
Equity Perception Study conducted
in March, 2015 with 83
professionals.
Differentiation Dimensions
Overview:
The CAR-T
Nomenclature and
Nascent Brand
Architecture
Brand Acumen’s
CAR-T
Brand Equity
Perception Study
March, 2015
A Review of the
Evolving
CAR-T Lexicon
Brand Acumen. “The Global Leader in Pharmaceutical Name Development and Submissions”

Celyad
Transposagen
Cellular Biomedicine
Carsgen
Unum
Caribou Biosciences
Xcyte
WuXi
Atara
CAR-T
émergent
nomenclature
corporatebrands

CAR-T
anewlexicon
chimeric antigen receptor therapy

CAR-T: Brand Equity Perception Study
In terms of Market Positioning,
we shaped our external
questionnaire to reflect each of
the company's 'overall clarity of
communication' and asked "What
were the key drivers that made
each respective company stand
out amongst their peers."
In this study we examined six (6) key
categories for assessment. They are
as follows:
Category Attributes Explained
For the Web Presence analysis,
we examined the inherent
associative brand (corporate)
characteristics as they related to
CAR-T. (This was particularly
important as Novartis is different
then the others as it is the only
'Big Pharma' player in the study).
Web
Presence
Market
Positioning

Collateral Material incorporates a
review of the analog (print, etc.) and
digital materials available from each of
the companies. We looked at the ease
of access to materials, educational
offerings, range and scope of the
materials and commitment to continue
to educate at various different
communication junctions (Patient,
HCP, etc.).
In terms of Differentiation, we focused
our assessment on many of the
traditional market differentiators and
the ability for each company to
leverage their core brand today and in
the future. Gauging these attributes
included asking: "How do you perceive
this company’s ability to deliver on the
promise put forth in their
communication?". "Will their therapy
work?". "Will they be first to market?”
"Who is best? Second Best? etc.
Differentiation
Collateral
Material

Depth. Here we examined each
company's respective pipelines and
how this resonates back to the
corporate brand identity. This was
more of a focus for Wall Street, VC's,
investors and peers. Questions
included: "Who has the deepest
minds?". "Who has the least likelihood
to suffer from brand technological
obsolescence?”
Analysts Perception asserts a battery
of questions for Wall Street Analysts,
VC's, biotech savvy investors and
hedge fund analysts who understand
and track/invest in the CAR-T space.
Depth
Analyst
Perception
Brand Acumen. “The Global Leader in Pharmaceutical Name Development and Submissions”v

SurveyDesign
37

To initiate the CAR-T Brand Equity
Study we surveyed five segments
of Key Innovation Leaders (KILs).
•  Bio Industry Writers (8)
•  Venture Capitalists (7)
•  Oncologists (35)
•  CAR-T Specific Researchers (21)
•  Market Makers/Analysts (12)
CAR-TBrandEquityPerceptionStudy
Brand Acumen’s CAR-T Brand Equity survey methodology brings together market,
brand, competitive, and technological attribute perceptions.
A corporate brand’s performance can be assessed allowing for a roadmap for
improvement to be identified in micro-niche biotech ecosystems.
samplesize/
numberofrespondents
Each of the six attribute
categories are scored from
0-100 with 0 being the lowest
and 100 the highest score.
The scores are weighted
based on respondents
answers to quantitative and
qualitative criteria.

chimeric antigen receptor therapy
CAR-T:
The Main Players
A Review of Company Nomenclature and
Results of the Brand Acumen CAR-T Brand Equity Perception Study

CAR-T
nomenclature
@NascentCAR-TNomenclature
tisagenlecleucel-T
Alternative Names:
•  Anti-CD19-CAR retroviral vector-transduced autologous T
cells - University of Pennsylvania
•  Anti-CD19-CAR transduced T cells - Novartis/University of
Pennsylvania
•  CART-019; CART-19; CART-19 cells
•  Chimeric antigen receptor-modified T cells against CD19 -
University of Pennsylvania/Novartis
•  CTL 019
•  LG-740
Most Recent Events
26 Feb 2015
Phase-II clinical trials in
Diffuse large B cell lymphoma
in USA (IV) (Novartis, pipeline,
February 2015)
08 Dec 2014 Efficacy data from
a pediatric study in Acute
lymphoblastic leukemia
presented at the 56th Annual
Meeting and Exposition of the
American Society of
Hematology (ASH-Hem-2014)
15 Oct 2014 Interim efficacy
and adverse events data from
two phase I trials in Acute
lymphoblastic leukemia
(second-line therapy or
greater) released by University
of Pennsylvania
tisa – gen – lec – leu – cel - T
generic name
•  MesoCART
•  huCART19
non-proprietary name
CRISPR/Cas9

Each of the six attribute categories are scored from 0-100 with 0 being
the lowest and 100 the highest score.

Each of the six
attribute
categories are
scored from 0-100
with 0 being the
lowest and 100 the
highest score.
The scores are
weighted based on
respondents
answers to
quantitative and

CAR-T
nomenclature
Sleeping Beauty
RheoSwitch®
platformbrands
AttSite®
UltraVector®
LEAP®

CAR-T
nomenclature
Lentiglobin®
Lenti-D®
Starbeam Study
North Star Study
branded clinical studies
brands

Each of the six
attribute
categories are
scored from 0-100
with 0 being the
lowest and 100 the
highest score.
The scores are
weighted based on
respondents
answers to
quantitative and

CAR-T
nomenclature
eACT™
T-Cell Factory B.V.
acquisition
collaboration
platformbrand

CAR-T
nomenclature
CaspaCIDe™
CIDeCAR™
GoCAR-T™
DeCIDe™
brands

CAR-T
nomenclature
Armored CAR technology
technology brand

CAR-T
nomenclature
pipeline identifier brand
UCART

evolutionary.
revolutionary.
disruptive.
60

http://www.harrisonhayes.com
CONTACT:
Bill Smith, Managing Director
wsmith@harrisonhayes.com

Specialty pharma and car t advisors 1[1]

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Specialty pharma and car t advisors 1[1]