The document discusses developing new fluorine-based drugs for positron emission tomography (PET) imaging. It notes the short half-life of fluorine-18 requires rapid synthesis of imaging agents. The solution presented is a single-step fluorination method that can increase production yields 10-fold at the same cost. Feedback from medical professionals and radiopharmaceutical firms indicates a need and market for improved imaging agents that are more readily available and have fewer side effects.

1. 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.
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.
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)

2. * 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
This is your brain on fluorine
* 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
I-Corps Final Presentation 12/14/11

3. *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
I-Corps Final Presentation 12/14/11

4. The Business Model Canvas - Initial
Technical Assistance
Nuclear Medicine and SOPs for precursors
(Image Atlas) Radiopharmacies
Radiology and drugs
Accessibility (RCY) FDA regulatory support
departments Recruit clinical sites
In vivo animal studies Purity Equipment producers
Develop regulatory Speed
plan for pre IND PET/SPECT Prescribing physicians
meeting Multiplatform Technical assistance
cGMP manufacturers ID cGMP CRO Sensitivity (nca) Radiologist who
Radiopharmacies Fund-raising Specific compounds perform studies
Pharmaceutical General Direct sales of precursor
IP
development methodology for
PoP data Drug developers
companies adding fluorine to Sales of packaged
lead compounds of precursor in cassettes
IP
interest
PoP data
Radiologists
Regulatory plan Cassette manufacturers
Understanding of
the regulatory
process
Sales of intermediates
Contract cGMP precursor manufacture
Salary, Rents
Technology license
Clinical trials
Product license (royalty)
I-Corps Final Presentation 12/14/11

5. • F-dopa iodonium intermediate
• F-dopamine iodonium intermediate Precursor Synthesis
Reagents
•ABX
•Eckert & Ziegler
GMP •GE MX module for TracerLab Precursor in Cassette
Cassette •Siemens Explora
Components
•TracerLab/ GE
•Eckert & Ziegler
•Siemens Explora Cassette (device)
GMP •Neoprobe
Compliant •Synthra
Synthesizer
•Siemens PETNet
•GE Amersham
•Cardinal Health
PET Drug •AAA
Finished product
Distributor •Iason
5
I-Corps Final Presentation 12/14/11

6. * 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

7. * 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
“Value is in the finished
Radiopharmaceutical
Distributors product”
•Siemens PETNet
•GE Amersham “Plug & Play”
•Cardinal Health
•AAA “We are definitely
•Iason interested IF you can
•Neoprobe
make it work on our
I-Corps Final Presentation 12/14/11 platform”

8. The Business Model Canvas - Pivot
Technical Assistance
Nuclear Medicine and SOPs for precursors
(Image Atlas)
Radiology and drugs Radiopharmacies
Accessibility (RCY) FDA regulatory support
departments Recruit clinical sites
In vivo animal studies Purity Equipment producers
Develop regulatory Speed
plan for pre IND PET/SPECT Prescribing physicians
cGMP manufacturers Multiplatform Technical assistance
meeting
Radiopharmacies Sensitivity (nca)
ID cGMP CRO Radiologist who
Fund-raising Specific compounds perform studies
General
Pharmaceutical IP methodology for Direct sales of precursor
development PoP data adding fluorine to Drug developers
companies lead compounds of Sales of packaged
IP interest precursor in cassettes
PoP data
Radiologists
Regulatory plan Cassette manufacturers
Understanding of
the regulatory
process
Sales of intermediates
Contract cGMP precursor manufacture
Salary, Rents
Technology license
Clinical trials
Product license (royalty)
I-Corps Final Presentation 12/14/11

9. UCSF
Memorial Sloan-Kettering
St. Jude Children’s Research Hospital
Stanford Medical Center
* Provide infrastructure for commercialization and clinical
trials
ABX
Albany Molecular
* Offer large-scale cGMP precursor production
* Met Biologics GMP production facility
TracerLab/ GE representatives at UNMC
Neptis
Eckert & Ziegler
Siemens Explora
* Offer GMP-compliant synthesizers
Neoprobe
Synthra I-Corps Final Presentation 12/14/11

10. Global PET Market ~ $6.3 billion
Serviceable available market ~ $1 billion
Initial Target Market (first 2
compounds) ~ $100 million
I-Corps Final Presentation 12/14/11

11. GFP F-18 DOPA
Parkinson’s Disease
SPECT DaTScan(GE) sales in Europe
~$100 M
-Current price - $2800/dose
-Medicare reimbursement - Current SPECT technology
$600/dose
Currently 1.5 million Americans
diagnosed with 60,000 new diagnoses
each year
Expected to rise with effective
imaging
PET imaging
GFP F-18 DOPA addresses this market
11
with a PET agent I-Corps Final Presentation 12/14/11

12. GFP F-18 Dopamine
• Neuroblastoma
• Childhood cancer with
prevalence comparable
to leukemia
• mIBG SPECT imaging now
used
• PET agent sought
• Carrier-free F-18 dopamine
synthesis shown by GFP
n
I-Corps Final Presentatio 12/14/11

13. GMP Finished
GMP
Precursor Drug
Finished
Cassette Finished
Product
Drug
Finished
Drug
$10’s/cassette $300 /cassette Product
Finished
Drug
Finished
Product
Drug Patients
Product
Drug
Finished
Product
Hospitals
Nominal Product
Drug
One time royalty Product
setup ($50) per
$140,000 cassette
$1700 per dose
~100 doses/cassette
13
I-Corps Final Presentation 12/14/11

14. The Final Business Model Canvas
SOPs for precursors
and drugs
Recruit clinical sites Accessibility (RCY)
In vivo animal studies Purity FDA regulatory support
Develop regulatory Speed
plan for pre IND PET/SPECT
meeting Multiplatform Technical assistance
Nuclear Medicine and Radiopharmacies
ID cGMP CRO Sensitivity (nca)
Radiology Specific compounds
departments Fund-raising
Equipment producers
cGMP manufacturers Intellectual Property
Sales of packaged
Radiopharmacies precursor in cassettes
PoP Data
Cassette manufacturers
FDA support
Licensing fees of precursor
Contract cGMP precursor manufacture
Salary, Rents
Clinical trials Product license (royalty)
I-Corps Final Presentation 12/14/11

15. * 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