Spoke to: firms covering 60%-80% of the global radiopharmaceutical market,

15 clinical PET users, and 7 GMP PET manufacturers, 5 officials of state

economic development (>90 people total)

PET is critical for the diagnosis and

treatment of cancer, neurological disease

(Parkinson’s, Alzheimer’s), and cardiac

disease. F-18 is the imaging isotope of

choice.

The Challenge: Synthesize and inject the drug within two hours.

(F-18 half-life = 110 min).

The Solution: Single step fluorination for PET imaging agents.

GFP does this better than anyone else.

*10X increase in production at same cost

*Pure “carrier-free” product to reduce side effects

*Robust manufacturing reliability

*Simplified regulatory approval

*Accelerate new agents to market

*Global PET market estimated to grow from $6.1 billion in 2010 to $9.8 billion in 2015

*GFP addresses the large unmet clinical demand for imaging agents

This is your brain on fluorine

I-Corps Final Presentation 12/14/11

I-Corps Final Presentation 12/14/11

*Kiel Neumann (Entrepreneurial lead)

*Graduate Student at UNL (PhD in May 2012)

* Thesis project developed technology used by GFP

*Stephen DiMagno PhD (PI)

*University of Nebraska Professor

* Expertise in the synthesis, physical properties, and

medicinal chemistry of fluorinated organic compounds

*Allan Green MD, PhD, JD (Mentor)

* Extensive experience in the pharmaceutical industry,

including the development and launch of imaging

products

* Currently teaches FDA Law at the Boston College Law

School

General

methodology for

adding fluorine to

lead compounds of

interest

The Business Model Canvas - Initial

Accessibility (RCY)

Purity

Speed

PET/SPECT

Multiplatform

Sensitivity (nca)

Specific compounds

IP

PoP data

Regulatory plan

Understanding of

the regulatory

process

Contract cGMP precursor manufacture

Salary, Rents

Clinical trials

SOPs for precursors

and drugs

Recruit clinical sites

In vivo animal studies

Develop regulatory

plan for pre IND

meeting

ID cGMP CRO

Fund-raising

Nuclear Medicine and

Radiology

departments

Technical Assistance

(Image Atlas)

FDA regulatory supportRadiopharmacies

Equipment producers

Prescribing physicians

Radiologist who

perform studies

Sales of intermediates

Technology license

Product license (royalty)

Drug developers

Pharmaceutical

development

companies

IP

PoP data

Radiologists

Technical assistance

cGMP manufacturers

Radiopharmacies

Direct sales of precursor

Sales of packaged

precursor in cassettes

Cassette manufacturers

I-Corps Final Presentation 12/14/11

5

Reagents

• F-dopa iodonium intermediate

• F-dopamine iodonium intermediate

GMP Cassette

Components

•ABX

•Eckert & Ziegler

•GE MX module for TracerLab

•Siemens Explora

GMPCompliantSynthesizer

•TracerLab/ GE

•Eckert & Ziegler

•Siemens Explora

•Neoprobe

•Synthra

PET Drug Distributor

•Siemens PETNet

•GE Amersham

•Cardinal Health

•AAA

•Iason

Precursor Synthesis

Finished product

Precursor in Cassette

Cassette (device)

I-Corps Final Presentation 12/14/11

*Increase manufacturing yields by 10-fold without increase of

the cost of inputs

*Confirmed by European producer of F-18 DOPA. GFP technology

would increase their output 10x

*Cold unlabeled drug in current PET products produces side-

effects that limit clinical use

*Children’s Hospital confirms side-effects of F-18-dopamine are a

problem and would be solved by GFP technology

*Current manufacturing technology limits the clinical

availability of important PET agents

*Discussion with US hospital confirms important agent (F-18 DOPA)

not available due to low yield and unreliability of current

syntheses

I-Corps Final Presentation 12/14/11

*Companies with proposed proprietary PET agents need improved

manufacturing pathways for reliability and economic success

*Detailed discussion with two potential R & D partners (one large

pharma, one small pharma) confirm need

Radiopharmaceutical

Distributors

•Siemens PETNet

•GE Amersham

•Cardinal Health

•AAA

•Iason

•Neoprobe

I-Corps Final Presentation 12/14/11

“Value is in the finished

product”

“Plug & Play”

“We are definitely

interested IF you can

make it work on our

platform”

General

methodology for

adding fluorine to

lead compounds of

interest

The Business Model Canvas - Pivot

Accessibility (RCY)

Purity

Speed

PET/SPECT

Multiplatform

Sensitivity (nca)

Specific compounds

IP

PoP data

Regulatory plan

Understanding of

the regulatory

process

Contract cGMP precursor manufacture

Salary, Rents

Clinical trials

SOPs for precursors

and drugs

Recruit clinical sites

In vivo animal studies

Develop regulatory

plan for pre IND

meeting

ID cGMP CRO

Fund-raising

Nuclear Medicine and

Radiology

departments

Technical Assistance

(Image Atlas)

FDA regulatory supportRadiopharmacies

Equipment producers

Prescribing physicians

Radiologist who

perform studies

Sales of intermediates

Technology license

Product license (royalty)

Drug developers

Pharmaceutical

development

companies

IP

PoP data

Radiologists

Technical assistancecGMP manufacturers

Radiopharmacies

Direct sales of precursor

Sales of packaged

precursor in cassettes

Cassette manufacturers

I-Corps Final Presentation 12/14/11

*Provide infrastructure for commercialization and clinical

trials

ABX

Albany Molecular*Offer large-scale cGMP precursor production

*Met Biologics GMP production facility representatives at UNMCTracerLab/ GE

Neptis

Eckert & Ziegler

Siemens Explora

Neoprobe

Synthra

*Offer GMP-compliant synthesizers

UCSF

Memorial Sloan-Kettering

St. Jude Children’s Research Hospital

Stanford Medical Center

I-Corps Final Presentation 12/14/11

Global PET Market ~ $6.3 billion

I-Corps Final Presentation 12/14/11

Serviceable available market ~ $1 billion

Initial Target Market (first 2

compounds) ~ $100 million

11

Parkinson’s Disease

SPECT DaTScan(GE) sales in Europe

~$100 M

-Current price - $2800/dose

-Medicare reimbursement -

$600/dose

Currently 1.5 million Americans

diagnosed with 60,000 new diagnoses

each year

Expected to rise with effective

imaging

GFP F-18 DOPA addresses this market

with a PET agent

Current SPECT technology

PET imaging

GFP F-18 DOPA

I-Corps Final Presentation 12/14/11

• Neuroblastoma

• Childhood cancer with

prevalence comparable

to leukemia

• mIBG SPECT imaging now

used

• PET agent sought

• Carrier-free F-18 dopamine

synthesis shown by GFPn

GFP F-18 Dopamine

I-Corps Final Presentatio 12/14/11

13

GMP

PrecursorGMP

Cassette

$10’s/cassette $300 /cassetteFinished

Drug

Product

$1700 per dose

~100 doses/cassette

One time

setup

$140,000

Nominal

royalty

($50) per

cassette

Patients

Hospitals

Finished

Drug

ProductFinished

Drug

ProductFinished

Drug

Product

Finished

Drug

ProductFinished

Drug

ProductFinished

Drug

ProductFinished

Drug

Product

I-Corps Final Presentation 12/14/11

The Final Business Model Canvas

Accessibility (RCY)

Purity

Speed

PET/SPECT

Multiplatform

Sensitivity (nca)

Specific compounds

Contract cGMP precursor manufacture

Salary, Rents

Clinical trials

SOPs for precursors

and drugs

Recruit clinical sites

In vivo animal studies

Develop regulatory

plan for pre IND

meeting

ID cGMP CRO

Fund-raising

Nuclear Medicine and

Radiology

departments

FDA regulatory support

Radiopharmacies

Equipment producers

Licensing fees of precursor

Product license (royalty)

Technical assistance

cGMP manufacturers

Sales of packaged

precursor in cassettes

Cassette manufacturers

I-Corps Final Presentation 12/14/11

Intellectual Property

PoP Data

FDA support

Radiopharmacies

*Limitations in current PET chemistry constrain the availability of

clinically important PET drugs

*Low manufacturing yields, unreliability of current procedures, and

manufacturing complexity are addressed by proprietary GFP

technology

*GFP technology addresses attractive markets

*GFP technology provides accessibility

*Proven synthesis of existing tracers with proven clinical use

* Improved manufacturing of third-party proprietary imaging agents

Submitted SBIR Phase 1 proposal

PI bought out of teaching commitment in spring

Rented space for GFP

Negotiated license agreement with UNL

Negotiating technology demonstrations

Met with State representatives for economic development