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Dr. Dina Uzri Dr. Peter Haberz Dr. Bradley Messmer
PI, Founder & CEO PhD, Rockefeller Univ. 3 yrs industry experience 20 yrs academic experience Inventor of IP Loco Pescador
CSO PhD, Harvard Univ. 3 yrs industry experience 10 yrs academic experience Pisces
Industry, Co-‐Founder & CFO PhD, Max Planck InsNtute 3 yrs industry experience 10 yrs academic experience Deckhand
Innovator Drug Maker (e.g. Genentech)
PaNent
Infusion Center/ Hospital
Specialty Distributors
The world today
Biosimilar makers (e.g. Mylan, Celltrion, Hospira, Biocon, Amgen, Merck, Baxter,
Actavis, Sandoz)
Distributors
The world in a few years
?
New problems = New market
Preclinical R&D
cGMP manufacturing
Manufacturing lot tesNng
MarkeNng
AuthenNcaNon
Pre-‐drug approval Post-‐drug approval
Blood tests (separate STTR)
Preclinical PK
Clinical trial PK & ADA
Phase 4 PK dosing
Assay cerNficaNon required
Medical Device – FDA regulated
PK straNficaNon/ dosing
What they need
+14
MVP for Use Case #1: law enforcement agents, staff at smaller clinics, overseas paNents
Readout: semi-‐quanNtaNve
Tangible Results
• New Partners: – Buchanan Ingersoll & Rooney in DC – 3 consultants – ZDT digital reader partner – License deal with UCSD
• Deals in the works – MedSci Chinese FDA
– Cipla Biologics, biosimilar developer in India
– Alava Biopharm Partners LLC, biologic CMO
– MBL InternaNonal CorporaNon (Japan)
– Oncology group within Clinical Services Group of HCA Healthcare
Investment readiness level
6
9. Validate Metrics That Mafer 8. Validate Rest of Canvas 7. Prototype High Fidelity MVP 6. Validate Right Side of Canvas 5. Validate Product/Market Fit 4. Prototype Low Fidelity MVP 3. Problem/SoluNon ValidaNon 2. Mkt Size/CompeNNve Analysis 1. Complete First-‐Pass Canvas
On our way to high fidelity MVP – IRL 7
3
2015 2018 2017 2016
mAb 150K
PK dosing 220K
mAb 1.5M
PK dosing 1.5M
LPS 220K
Grants
Equity Investors
150K 2-‐4M
MuDPAQ 225K MuDPAQ 1.5M
Sample sparing U24 1.6M
DeNAno R33 900K
LPS 1.5M