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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)
* 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
*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
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
• 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
* 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




                                           “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”
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
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
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
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
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
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
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
* 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

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Ground Flour Pharma final NSF I-Corps presentation

  • 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