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A 
New 
Drug 
to 
Restore 
Func1on 
A2er 
Spinal 
Cord 
Injury 
Team 
15 
A. 
Taylor 
Bright, 
C-­‐Level 
Officer 
Travis 
L. 
SDles, 
PI 
Total 
in-­‐person 
interviews 
to-­‐date 
(total): 
89 
(112) 
Weekly 
Interview 
Average: 
11.2 
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 
$50B 
$3B 
The 
customers 
of 
our 
customers 
are 
demanding 
our 
solu1on! 
This 
will 
be 
easy!!!
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 
~18 
MONTHS 
FROM 
CUSTOMER 
AWARENESS 
TO 
PROVE 
PRE-­‐CLINICAL 
RELEVANCE 
Pharma/Biotech 
Addresses 
unmet 
market 
need 
“signal 
of 
efficacy” 
Strong 
FDA 
Fast 
Track 
candidate 
PharmaceuDcal 
Company 
IP 
& 
Data 
Novoron 
Bioscience’s 
Value 
ProposiDons 
Channel 
Customer 
Segment 
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. 
Drug 
ProducDon 
Data 
ProducDon 
IP 
Acquire 
KOL 
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 
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. 
Outcome 
Measures 
for 
Proof 
of 
Concept 
Study 
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)
BMC 
– 
LeK 
Side 
12 
Key 
Partners 
Key 
AcDviDes 
Value 
Props. 
Drug 
ProducDon 
Data 
ProducDon 
IP 
Acquire 
KOL 
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 
ScienDsts 
Lab 
Space 
Animal 
Studies 
IP
AcSviSes, 
Resources 
& 
Partners 
13 
Grant 
funding 
ScienDfic 
team 
Lab 
faciliDes 
Pharma/ 
Biotech 
Drug 
producDon 
KOL 
support 
IP 
related 
acDviDes 
acquisiDon 
Proof-­‐of-­‐Principle 
data 
acquisiDon 
Research 
InsDtutes 
FORE-­‐SCI 
Specialty 
IP 
law 
firm 
– 
Biologic 
Drugs 
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 
0 
12 
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 
0 
12 
ConfirmaTon 
and 
non-­‐primate 
24 
36 
large 
mammal 
studies 
Time 
(months) 
IND 
Enabling: 
ADME/tox 
and 
CMC 
$1.0 
MM 
$1.6 
MM 
$5.8 
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

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Novoron I-Corps@NIH 121014

  • 1. A New Drug to Restore Func1on A2er Spinal Cord Injury Team 15 A. Taylor Bright, C-­‐Level Officer Travis L. SDles, PI Total in-­‐person interviews to-­‐date (total): 89 (112) Weekly Interview Average: 11.2 Shawn Gahr, Industry Expert December 10, 2014
  • 2. 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 $50B $3B The customers of our customers are demanding our solu1on! This will be easy!!!
  • 3. 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
  • 4. 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
  • 5. Customer Delivery Diagram 5 ~18 MONTHS FROM CUSTOMER AWARENESS TO PROVE PRE-­‐CLINICAL RELEVANCE Pharma/Biotech Addresses unmet market need “signal of efficacy” Strong FDA Fast Track candidate PharmaceuDcal Company IP & Data Novoron Bioscience’s Value ProposiDons Channel Customer Segment Intravenous administraDon
  • 6. What We Did: Interviewed Customers 6 Development Scouts: 8 BD Execs: 4 Senior ScienDst: 14 Biologic Dev Execs: 7
  • 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
  • 8. 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
  • 9. BMC – LeK Side 9 Key Partners Key AcDviDes Value Props. Drug ProducDon Data ProducDon IP Acquire KOL 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 ScienDsts Lab Space Animal Studies IP
  • 10. 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
  • 11. 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. Outcome Measures for Proof of Concept Study 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)
  • 12. BMC – LeK Side 12 Key Partners Key AcDviDes Value Props. Drug ProducDon Data ProducDon IP Acquire KOL 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 ScienDsts Lab Space Animal Studies IP
  • 13. AcSviSes, Resources & Partners 13 Grant funding ScienDfic team Lab faciliDes Pharma/ Biotech Drug producDon KOL support IP related acDviDes acquisiDon Proof-­‐of-­‐Principle data acquisiDon Research InsDtutes FORE-­‐SCI Specialty IP law firm – Biologic Drugs 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 $
  • 14. 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.
  • 15. What We Thought: Finance & OperaSons Timeline 15 Refine/Scale up producTon In vivo proof of concept 0 12 Time (months) $1.0 MM Opportunity for license or acquisiDon 18
  • 16. We What We Know: Finance & OperaSons Timeline 16 Refine/Scale up producTon In vivo proof of concept 0 12 ConfirmaTon and non-­‐primate 24 36 large mammal studies Time (months) IND Enabling: ADME/tox and CMC $1.0 MM $1.6 MM $5.8 MM
  • 17. 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.
  • 18. 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.
  • 19. 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.
  • 20. 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.
  • 21. I Corps Video hnp://youtu.be/Nxxs4JrhJs8