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A New Drug to Restore Func1on A2er Spinal Cord Injury Team 15
Total in-‐person interviews to-‐date (total): 89 (112) Weekly Interview Average: 11.2
A. Taylor Bright, C-‐Level Officer
Travis L. SDles, PI
Shawn Gahr, Industry Expert
December 10, 2014
Oh, how naive we were.... 2
• Quickly validated the underlying paDent need
– 15,000 new cases of SCI in US each year – NO drug approved to treat SCI – Pa1ents and Physicians clamoring for any drug to help those afflicted
• IdenDfied very large unmet market with great revenue potenDal
The customers of our customers are demanding our solu1on! This will be easy!!!
$50B
$3B
BMC – Where We Started 3 Key Partners Key AcDviDes Value Props. Customer Rel. Customer Seg.
Key Resources Channels
Cost Structure Revenue Streams
University FoundaDons NIH CRO Venture Phil. Sci. Comm.
IP for unmet need Fast Track candidate Block RhoA Admin. via IV
Sanofi J&J Genentech Amgen NovarDs Merck Raptor BioAxone
Drug ProducDon Data ProducDon IP Acquire KOL
IP assets Data ScienDfic Team
Direct Sales
ScienDsts Lab Space Animal Studies IP
DivesDture License Fees
BMC – Right Side 4 Value Props. Customer Rel. Customer Seg.
Channels
Revenue Streams
IP for unmet medical need FDA Fast Track candidate AdministraDon via IV Target validated human biomarker (RhoA)
Sanofi J&J Genentech Amgen NovarDs Merck Raptor BioAxone
Direct Sales
DivesDture License Fees
Customer Delivery Diagram 5
Pharma/Biotech
“signal of efficacy”
Addresses unmet market need
Strong FDA Fast Track candidate
PharmaceuDcal Company
IP & Data
Novoron Bioscience’s Value ProposiDons Customer Segment Channel
~18 MONTHS FROM CUSTOMER AWARENESS TO PROVE PRE-‐CLINICAL RELEVANCE
Intravenous administraDon
What We Did: Interviewed Customers 6
Development Scouts: 8 BD Execs: 4 Senior ScienDst: 14 Biologic Dev Execs: 7
What We Learned 7
“We do not believe there is a valid pre-‐clinical model for SCI or stroke. No pre-‐clinical data will convince Genentech to buy early-‐stage SCI drug. Would look at data a2er a successful Phase 2 Clinical Trial.”
-‐ Senior ScienDst, Genentech “We are not interested in SCI but are interested in {AD, MS, etc.}.”
-‐ Senior ScienDst, Amgen; BD Regional Director, Sanofi “No one [Big Pharma/Biotech] will partner early stage in SCI.”
-‐ CEO, BioAxone Bioscience “We are not interested in early-‐stage SCI drugs.”
-‐ Senior Director of New Ventures, J&J
BMC – Right Side 8
Value Props. Customer Rel. Customer Seg.
Channels
Revenue Streams
IP for unmet medical need FDA Fast Track candidate AdministraDon via IV Block RhoA acDvaDon in damaged neurons Next SCI clinical candidate SCI PoC candidate
Sanofi J&J Genentech Amgen NovarDs Merck Raptor – Poten1al Partner BioAxone
Direct Sales
DivesDture License Fees
BMC – LeK Side 9 Key Partners Key AcDviDes Value Props.
Key Resources
Cost Structures
University FoundaDons NIH Contract Research Org. Venture Philanthropist ScienDfic CommunicaDon
IP for unmet medical need FDA Fast Track candidate AdministraDon via IV Block RhoA acDvaDon in damaged neurons Next SCI clinical candidate SCI PoC candidate
IP assets ScienDfic Team PoC in Animal Model
Drug ProducDon Data ProducDon IP Acquire KOL
ScienDsts Lab Space Animal Studies IP
Key Resources Learning 10
Customer Interviews: “Not only more data, but more rigorous, replicated data is required for an SCI
drug.” Academic KOLs: 20 SCI FoundaDons: 8
“Field liJered with failures and no successes” -‐ BioAxone BioSciences, CEO
BePer Data Required 11
• Randomized, double-‐blind animal trials at mulDple independent research centers.
• Each trial must assess mulDple behavioral, histological, and biochemical outcome measures.
Gait and ambulaDon (BBB, gridwalk) Sensory (Von Frey) Signal of efficacy/biochemistry (AcDvaDon of RhoA) Immune/scar effects (histology) Neuronal growth proximal and distal of lesion site (tracing) Cervical injury (forepaw grip strength, pellet retrieval)
Outcome Measures for Proof of Concept Study
BMC – LeK Side 12 Key Partners Key AcDviDes Value Props.
Key Resources
Cost Structures
University FoundaDons NIH Contract Research Org. Venture Philanthropist ScienDfic CommunicaDon
IP for unmet medical need FDA Fast Track candidate AdministraDon via IV Block RhoA acDvaDon in damaged neurons Next SCI clinical candidate SCI PoC candidate
Data PoC in Animal Model Replicated, MulD-‐outcome PoC in Man
Drug ProducDon Data ProducDon IP Acquire KOL
ScienDsts Lab Space Animal Studies IP
AcSviSes, Resources & Partners 13
Lab faciliDes
ScienDfic team
Grant funding
Pharma/ Biotech
Drug producDon KOL support acquisiDon IP related acDviDes
Proof-‐of-‐Principle data acquisiDon
Specialty IP law firm – Biologic Drugs
Research InsDtutes
FORE-‐SCI
SAB/KOL advisors
NIH/FoundaDons/ Venture
philanthropists
Linle Dog CommunicaDons
Brand
ScienDfic communicaDons
The Miami Project
InsDtute for Neural RegeneraDon
$
$$
Non Accrued Expenses (under consideraSon)
$
$
$
ACTIVITIES
PARTNERS
$
What’s Next? 14 • 36-‐month plan to develop our putaDve SCI drug to a stage where Big Pharma/Biotech would find value.
• IdenDfied financing mechanisms to enable longer development path. – NIH SBIR Phase 2 – NINDS CREATE Bio Discovery/Development – Private foundaDons: Rick Hansen, Spinal Research
• Secured partners needed to assist in more complex development plan.
What We Thought: Finance & OperaSons Timeline 15
Refine/Scale up producTon
In vivo proof of concept
12 0
Time (months)
$1.0 MM
Opportunity for license or acquisiDon
18
We What We Know: Finance & OperaSons Timeline 16
Refine/Scale up producTon
In vivo proof of concept
12 36 24 0
Time (months)
ConfirmaTon and non-‐primate large mammal studies
IND Enabling: ADME/tox and CMC
$1.6 MM $5.8 MM $1.0 MM
What’s Next? 17 • 36-‐month plan to develop our putaDve SCI drug to a stage where Big Pharma/Biotech would find value.
• IdenDfied financing mechanisms to enable longer development path. – NIH SBIR Phase 2 – NINDS CREATE Bio Discovery/Development – Private foundaDons: Rick Hansen, Spinal Research
• Secured partners needed to assist in more complex development plan.
What’s Next? 18 • 36-‐month plan to develop our putaDve SCI drug to a stage where Big Pharma/Biotech would find value.
• IdenDfied financing mechanisms to enable longer development path. – NIH SBIR Phase 2 – NINDS CREATE Bio Discovery/Development – Private foundaDons: Rick Hansen, Spinal Reseach
• Secured partners needed to assist in more complex development plan.
AddiSonal Opportunity 19
2014 2014
We can cure SCI!!!
What about MS? Tell us
about MS?
I wonder if anyone around here is
talking about MS…
Novoron and an MS therapeuTc?
• SubmiJed STTR for MS on December 5th. • Strong early indicaTon for MS from technology. • Customer interviews indicate much stronger interest in MS
therapeuTc.
We are a Go 20
Go with a Nominal Pivot The feasibility data generated in the Phase 1 grant will provide the appropriate technical founda1on for a Phase 2 applica1on, AND we are largely targe1ng the customer segments that we had originally an1cipated.
Investment Readiness Level: Valida1on of product/market fit is needed to get us to level 5.
I Corps Video
hnp://youtu.be/Nxxs4JrhJs8
