EFTA00506070.pdf
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2013-08-22
Epiphany
BIOSCIENCES -
1
EFTA00506070
Corporate Overview
• Mission: To improve the health of patients suffering from serious
diseases and unmet medical needs of viral origin and to build
shareholder value by developing new antiviral therapies
• Founded: 2006
• Raised: $36m
• Ownership: Privately Held
• Headquarters: San Francisco, CA
2
BcisL:er
2
EFTA00506071
2013-08-22
Epiphany Biosciences' Investment Thesis
• Late-stage clinical antiviral company with two attractive, high-potential candidates
• EP8-348 is a proven drug candidate with multiple "shots-on-goal"
• Safe and effective small molecule with broad spectrum antiviral activity
• fin competition for unmet medical needs
• No antiviral approved for shingles associated pain
• No approved antivirals for EBV
• Paradigm-changing therapeutic approach to a variety of serious diseases, incl. orphan indications
•
EP8.510 is a Nucleotide Polymerase Inhibitor (NPI) for HCV with a highly competitive
preclinical profile versus other high profile leading NPIs
•
Streamlined and efficient development and clinical plans
•
Able to achieve major value-inflection points in multiple clinical programs in
approximately 1.2 years
•
Highly experienced team with track record of success
3
Epphary
•
&oscences
Add spreadsheet details
3
EFTA00506072
Epiphany's product pipeline
Program
2013
2014
2015
2016
2017
2018
2019
l
Il
l
EPB-348
I
VZV-Shingles
EBV-Transplant
Pt 2t0 Pi r Tra
Pe 2 rns
Pi Items; TT.I
Atcrvo3 Mao Clogintrg
M2 Tsar
-I
—
AttmN 2Wvow Gettateg
EBV.Autoimmune (Multiple Sclerosis)
Dark Tam
Pet MI
n
Ph 3Tila1—n
EBV-Autolnunune (Idiopathic Pulmonary Fibrosis)
EBV.OncologYINasal Pharyngeal Carcinoma)
S
nabs
I
Ph 3 TM
maim
Pb3ins
EPB-510
Hepatitis C
RUMS
mita
Pons
4
4
EFTA00506073
Valomaciclovir Stearate (EPB-348):
Epiphany's late-stage product opportunity
EPB-348 is an effective, late-stage small molecule antiviral
•
Safe and effective small molecule with broad spectrum antiviral activity including Varlcella Zoster Vitus (V2V),
Epstein.Barr Virus IEBV), & Herpes Simplex 1 and 2 (HSV-1/2)
History of Valomadclovir Stearate (EPB-348)
•
EPB-348 invented by MedMr AB (MIV.606)
•
Ucensed to Abbott laboratories- developed through Phase 2a (ABT-606)
•
Ucensed to Reliant Pharmaceuticals -developed tablet formulation (RP-606)
•
Ucensed to Epiphany Biosciences - completed key Shingles & EBV proof-of.concept Phase 2 studies
Proven antiviral activity, dinical impact, & safety in multiple Phase 1 & 2 trials
•
Successful Phase 2b trial for shingles met primary endpoint
•
Successful Phase 2 trial for EBV and infectious mononucleosis met primaryendpoint
Highly favorable safety profile
•
EPB-348 has been dosed to more than 720 patients
•
Mete than 130 patients have received multiple doses of 3 grams or more
•
No maximum tokratod dose yet determined
Well characterized mechanism of action
•
Selective viral DNA-polymerase inhibitor
•
Up to 400-times more potent than Acydovir with better Intracellular concentrations and half-lives
5
EFTA00506074
2013-08-22
Strong in vitro & preclinical data provide consistent rationale
why EPB-348 is more potent than other antivirals
Active Drug
VZV
EP8-348
•
thkintsciclovii Stn.
iptoditvg)
wal
l. 1j1
Thyrnitine
142G
Kings.O
Welts
•
YAsDNA
Polymerise
H2G has improved cellular permeability, a faster phosphorylation rate,
and better intracellular stability and persistence
•
Against a variety of different WV strains in vitro, H2G is up to 400x more potent than acyclovir (ACV)
•
H2G is approx. 250x-better substrate for VZV encoded thymidine kinase than ACV
•
The intracellular concentration of H2G-TP is more than 140x greater than ACV-TP
•
H2G-TP has a longer Tx than ACV-TP
•
EPB-348 has excellent activity in the gold-standard in vivo Simian Varicella Virus monkey model
Lon. MI *I
Atnntrts Amen O•nativr.
AMU Itale.G
Man. &an Poilater. MIL; MI; Ws. V! nehlrelacca Agents Oman., 11XL.17,1170.
6
6
EFTA00506075
Valomaciclovir Stearate (EPB-348)
Lead Indication:
Shingles &
Shingles-Associated Pain
Epiphany
Biosciences
7
EFTA00506076
2013-08-22
EPB-348 can address the important unmet needs
of shingles
Differentiating advantages of EPB-348 for shingles
•
Shingles/Zoster associated pain impact
•
Wider treatment window
•
Simpler dosing regimen
Proven shingles efficacy
•
EPB-348 met Phase 2b Shingles Trial endpoints
At lower, less frequent doses, EPB-348 was statistically non-inferior to higher dose Valtrex
•
Data is directionally consistent with dose dependent improvement
De-risked & cost effective late stage clinical development plan
•
Ability to go against placebo for pain and antiviral endpoints in Phase 3 trials
•
Phase 3 trials cost significantly offset if performed in countries with =credits
•
No competing shingles trials actively recruiting
8
EFTA00506077
Phase 2b shingles study designed to show
EPB-348 efficacy versus Valacyclovir
Screening 72 h
Rankrrinsion
Days 2.7
Days 8.28
Days 29-120
Treatment
Fdlow.up•
Follow-up“
Ertl-3431
lg QD,
Treatment
2g QD,
Regimen
EPB348
am
ictig
,
—VV
1 g TID,
Masan Study De*
0 Non infericoty stud/ (Valac,olovir as comparator)
O60% powered with respect toprimly endpoint
O Rardomued, double-Wind, acuve-contnolled,mulb-center. parallel-group
006 U.S. dowel centers
°Patients were Followed for three maths with up to IS mots
O Baseine demographics homogeneous& babnced across treatment group
0373 immunocompetent adult pabents randomized into 4 sroups
Endpoints
O primary: Time to complete crusting
O Secondary: Time to complete cassaben o pain
OOyeral safety parameters
• Day 28 Final Vise for patients wd rash & pain resolution
** for patients with oilcans rash or pain at Day 28
.3s any for Pit purposes. Data mduded n final analysis
9
9
EFTA00506078
EPB-348 met Phase 2b primary antiviral endpoint
of time-to-complete crusting versus Valacyclovir
•
EPB-348 once-a-day was statisticallynon-inferior or ;superior to valacyclovir hree-
times-a-day in both the ITT and PP populations for time to complete cru Ling by day 28
Parameter
EPB-348
1000 mg
Once a day
EPB-348
2000 mg
Once a day
(1,8-34S
3000 mg
Once a day
Valacycloylr
1000 mg
Three times a day
Patient age
nose IVA.)
218
..
.18
250
218
218
250
218
218
250
218
218
2S0
Analysis
ITT
PP
ITT
ITT
PP
ITT
ITT
PP
ITT
ITT
PP
ITT
Number of
Patients INI
11S
102
72
117
107
74
II
16
12
109
1CO
6/
Mean
(SO
11.1
10.77)
11.3
(0.77)
11.2
(096)
10.7
(na)
10.7
(ida)
11.2
(0141
2.2
11.06)
7.5
was)
7.2
n4s)
11.5
(0.79)
116
(0.11)
122
(1.03)
Confidence
Interval
.1,842,
2.501
.2.470,
1.942
.3.372,
2.239
-2243,
1.192
-2295,
1.255
-3.791.
1.406
.8.252,
4.345
6.190,
.0.073
-10.231.
-0.229
P.value
(unadjusted,
0491
0.601
0.949
0.597
0.571
0.337
0.006
0.019
0.009
Pei "/,umnslon wows .1cycbor lot th•intatment dumb. norm bale in insunotanipelatt Sub ArrmnW& dead. bind Alsomorttaled tat
TV, t nni MC4 Wol 2012.Sa 1224.
10
7
10
EFTA00506079
Statistically superior time to complete cessation
of pain for patients with pain at Day 28
•
Patients who still had pain on Day 28 and were treated with EP8-348 (2 g QD) had a
statistically s'gnificant 'shorted time to pain resolution by nearly 2 weeks than the
control group (ITT)
valacydovir
Paramet
EPB-MS
1000 mg
Once &day
EPS 348
2000 mg
Once a day
Valacydovir
1000 mg
Three limes a day
Patient age
range (y.o.)
118
250
318
250
:1a
Number of
patients (N)
28
21
29
23
23
20
Mean
47.9
as
33.1
31.4
46.3
47.2
)SE)
16.00)
14.39)
(4.711
(5.041
15.601
IS 21)
Confidence
10.265,
(32.010,
(1.033,
1.33.106.
Interval
2.410)
.3.087)
5.976)
0.4741
P-value
(umadJusled)
0.133
0.047
0.034
11
EFTA00506080
Incidence of any pain in ≥50 year old patients was
consistently lower for EPB-348 compared to Valacyclovir
0
$
9)
0y
nwhi. (semi
cEP04Ot2900)
30
Vaster Associated Pain (ZAP)
60
90
Day
120
• There is a natural resolution of pain in a subset of patients with shingles
• Antiviral treatment can reduce the incidence of pain and improve time to pain
cessation
12
12
EFTA00506081
EPB-348 retains its efficacy on day 3 after
rash, suggesting a wider treatment window
• EPB-348 has statistically significant
o time to complete crusting on
for those 50 years and older compared to
:0
1(
yir TT)
)Day 3
Parameter
EPB-348
1000 mg
Once a day
EPB-348
2000 mg
Once a day
Varacyclovir
1000 mg
Twee times a day
Patient age
range (y.0.)
218
2 SO
z18
z50
218
250
Noun
048
4472
048
4472
048
68.n
048
445-72
0-08
4472
ea
48-72
Number of
patients (N)
78
32
50
22
80
3?
41
2?
75
34
43
24
16.1
1149)
Mean
(SE)
12.7
(9.51
101
ISM
12.1
11.23)
11.1
(1.62)
10.5
(1.21
11.2
(2.2)
11.2
(1.0SI
11.2
11.42)
10.8
17.5)
13.3
WO
10 .5
(1.121
P-value
0.11
0.14
0.152
0.012
0.39
0.59
0.775
0.051
3
13
EFTA00506082
EPB-348 has consistently proven to be a more
potent antiviral than Valacyclovir for shingles
In vitro
•
H2G is up to 400-times more active than ACV against the shingles virus
In vivo
•
EPB-348 is more effective against SW in a monkey infection model compared to ACV
Clinical
•
Phase 2a clinical shingles trial (Abbott)
•
Study showed a 10% decrease In pain duration with 750 mg BID, compared to acyclovir
Parameter
EP8-348
230 mg
Take a day
EPB-348
MO mg
Twice a day
M8-348
730 mg
Twice a day
Acyclevfr
800 mg
Flue times a day
N
21
20
17
21
Median (d)
109
107
106
150
Phase 2b clinical shingle trial (Epiphany)
•
1 g EPB-348 QD Is stall tkally non-Inferior to 1g Valtrex TID (3g total) for time-to-complete crusting IPP)
•
2g EPB-348 QD had a statistically significant shorter time to pain resolution for patients
•
No efficacy dropoff (or dosing on Day 3 for EPB-348 (1 82 g) unlike Valtrex TID (3g total)
14
EFTA00506083
2013-08-22
EPB-348 appears to be very safe
Results to-date show EPB-348 to be safe and well tolerated
• EPB-348 has been dosed to more than 720 patients
• More than 130 patients have received multiple doses of 3 grams or more
Phase 2b Safety Highlights
• No study drug discontinuations due to related adverse events
• Patients with compromised renal function tolerated the drug very well
• Side-effects were similar between treatment groups and generally mild in nature
• Two discontinuations from the study based on adverse events deemed not
related to study drug
• Three serious adverse events; all deemed not related to study drug (blind
maintained)
15
15
EFTA00506084
2013-08-22
Phase 2b/3 pivotal shingles trial to be focused on
demonstrating key point of pain differentiation
According to the FDA, Valtrex and Famvir have not shown any statistical
differences compared to control for pain
• Consequently, EPB-348 Phase 2b/3 trials can go against placebo for both antiviral
(cutaneous) and pain endpoints
Previous clinical studies with Acyclovir, Valtrex and Famvir suggest that they may
have some impact on reducing pain & PHN
• The pain impact of these antivirals have not been proven in sufficiently powered
prospective studies
• Use of higher dose levels of these less potent antivirals is not possible as they are
already dosed near their maximum approved dosage levels
Since EPB-348 is MOM effective against shingles than Valtrex across a variety of
parameters, it is anticipated that EPB-348 could meet both pain and antiviral
endpoints in Phase 2b/3 trials, especially against placebo
16
16
EFTA00506085
Phase 2b/3 pivotal shingles pain trial
design & milestones
Screening
72 h
RandcakaSon
7-day
treatment
143-day
follow-up
Treatment
Regimen
EPB-348
2g BID
Study Design
•
Double-blinded, placebo controlled
•
Patients aged 50 to 80 years old
•
Primary endpoint: incidence of pain at Day 60
Placebo
Milestones
•
7-month enrollment period
•
5 month subject participation period
•
1-Month from Last patient out to database lock
•
1-Month from database lock to topline data
Highly cost-efficient clinical trial plan
•
Example: Australia has 615% rebate/tax credit
•
No competing shingles trials actively recruiting
•
17
17
EFTA00506086
2013-08-22
Shingles is the first target market for EPB-348,
growing to more than $1 Billion
Market Potential (in Smillions)'
•
1/04
120>
•
5:01
flak.,
OEU
10
OUS
408
•
108
2018 ... 2012 2019 2014 2015 1018 1011 1018 1010 1020 1011 1011
Some. IMS extrapolated nog governmental demographic prcleebons
18
I
Sales volume in the major
pharmaceutical markets projected to
grow to >$1 billion (IMS)
Key demographic of patients >60 years
old is growing with the aging of the
global population
Annual incidence of shingles in over 60
population is 1.1%
Projected 38% growth in the number of
shingles patients over 60 years old in
the Asian markets by 2020, including
>5.4 million cases in China
•
Branded drugs dominate the worldwide
markets solely on perceived dosing
convenience and effective sales and
marketing (GSK)
18
EFTA00506087
EPB-348's advantages for shingles would allow
it to dominate the market
Existing shingles antivirals
•
No shingles oain heneflit • According to the FDA, Valtrex and Famvir have not shown any statistical differences
compared to control for pain
•
Narrow Mensal& Index: Approved dosages for shingles are very close to maximum approved dose
•
imited treatment window: Must be administered within 72 hours of shingles rash onset & efficacy drops off
significantly when administered between ag-72 hours
•
Complicated dosing regimens: Acyclovir: S-times a day; Value< • & Famvir': 3 times a day
Shingles Vacdne
•
Minimal market impact of only 1-2%
•
High co-pay, limited efficacy, unapproved for immunocompromised and those less than 50 years old
•
From 2007-2009, lostavax • uptake was extremely low at 3.9% (Langan, SM et of PLOS 2013)
Unapproved shingles antiviral,
•
ASP-2151: Hellcase Inhibitor development officially suspended in 2011 because of toxicity
•
FY-100: No dinical or In vivo demonstration of efficacy
•
No apparent dinkal evidence of FV-100 antiviral activity In Phase 2 trial
•
No statistical endpoints achieved with respect to pain in Phase 2 trial
•
Mechanism of action is unknown & no antiviral activitydemonstrated in standard ,n who models
L9
19
EFTA00506088
EPB-348 can be marketed for shingles with a small
sales force & with the possibility of early revenues
2
=
Myth: A large primary-care sales force is required for shingles
• A small sales force on focus on tertiary care centers that see high-
volumes of patients such as the urban elderly
• Anticipate sales of approximately of $200 m using this focused approach
• Use at tertiary centers will drive further market expansion
Revenue after Phase 2b/3 Shingles trial & Ph 2 EBV-transplant may be
possible as part of Named Patient Programs
MI
a
20
EFTA00506089
Valomaciclovir Stearate (EPB-348)
Second Indication:
Epstein-Barr Virus (EBV) & Transplant
11 __
IIIIIIIIII
21
EFTA00506090
EPB-348 has already demonstrated human clinical proof-
of-concept efficacy against Epstein-Barr Virus (EBV)
EPB-348 has excellent EBV activity
•
10.20-fold more potent in vitro than acyclovir, penciclovir, or foscarnet
Phase 2 study of EPB-348 for EBV infectious mononucleosis
•
Double-blinded, placebo-controlled
•
Patients received 2 g EPB-348 twice a day for 21 days
•
Primary endpoint: proportion of subjects with a 100-fold drop in EBV in oral washings
Oral supernataM
EPES-348
(N=11)
Placebo
(N.10)
P
value
Number of subjects with 22 logg, decrease
In EBV copies/ml at end of treatment
8
1
0.008
Median (mean) decrease in EBV viral load
during dosing period
3.11(2.82) 0.30(0.05)
0.000
22
22
EFTA00506091
2013-08-22
EPB-348 significantly reduced EBV load in a
Phase 2 infectious mononucleosis trial
I0
0
3. 3
O
Oral Supernatant
co
gEe 2
_a
C
t
0
10
201
30
I Study pay
121 Day Treatment Mabel
I Fallow Up period fro drug)
40
1
100
ig°
A
50
tl
ICIAC 2009
Time to < 1000 copies/mL Oral Sup
150
Placebo
Vaixnecclov •
10
15
Days
p -0 04
2;1
23
EFTA00506092
EPB-348, transplant, & Epstein-Barr Virus (EBV)
Background
•
EBV-driven diseases such as Post-Transplant Lymphoprotiferative Disorder (PTLD), EBV-encephalitis,
and EBV-pneumonitis are important complications following organ transplantation and can result in
significant morbidity and mortality
•
ND antiviral approved for EBV — no competition, first to market
•
EBV-driven transplant diseases are eligible as an orphan indication
•
Additionally, Varicella-zoster virus (WV) frequently causes severe infections in patients who have
undergone bone marrow transplantation.
EPB-348 and EBV
•
EPB-348 to be used to treat or prophylaxis for at-risk transplant patients
EBV-Transplant Infections and Complications
•
Over 28,000 solid organ transplants and 10,000 bone marrow transplants in US annually
•
Early sales possible via Named Patient Program
•
Potential market of approximately $200 million in the US
.
Comparable: vaigancicimir Wall had sales of approx. $300 m in the us
.
70% of Val sales were for transplant patients l$200 m)
24
24
EFTA00506093
EBV-Transplant Phase 2 Trial (EPB-348)
Design & Milestones
Study Design
•
Double-blinded, placebo controlled
•
40 transplant recipients with EBV wernia
•
Primary Endpoint: Virologk response to therapy
Milestones
•
12-month enrollment period
•
2 month subject participation period
•
1.5-Month from cast patient out to database lock
•
1.5-Month from database lock to topline data
Treatment
Regimen
Screening/
Randomization
21-day
35.day
treatment
I I
follow-up
EPB 348
2g BID
Placebo
BID
Success Factors
•
utilizing established clinical network of well-respected, high-volume centers in US and Canada
•
Objective endpoint: Viroklk response to therapy
•
EPB-348 has already proven to be a potent anti-EBV agent in the previous infectious mononucleosis - therefore,
high likelihood of success to reduce EBV (as well as VZV) in viremia transplant patients
25
EFTA00506094
Valomaciclovir Stearate (EPB-348)
Additional Indications:
Autoimmune & Proliferative Diseases
Impacted By EBV
Epiphany
Biosciences
26
EFTA00506095
EPB-348 for orphan autoimmune & proliferative
diseases impacted by herpesviruses (EBV, HSV-1)
Background
•
EBV appears to play an etiological and/or exasperating role In a number of rare, but serious and life-threatening
diseases, including:
•
Multiple Sclerosis, Idiopathic Pulmonary Fibrosis, & Nasopharyngeal Carcinoma
EMI-348 and EBV-AutoimmuneAymphoproliferative disease
•
These indications offer potential significant add-on upside for EPS-348as well as representing a paradigm-changing
therapeutic approach to a variety of serious diseases, many of which have orphan status
•
Chronic toxicity studies required prior to trials with longer-term EP8-348 dosing
Multiple market opportunities In orphan diseases
•
Multiple Sclerosis (MS)
•
US prevalence of approx. 400,000 patients; Potential market of approx. $1.5.3 billion based on Copaxone,
Avonex, & Rebif comparables
•
ldlopathk Pulmonary Fibrosis (IPF)
•
US incidence of approx. 20,000-50,CCOcases annually; Global market was valued at $2 billion in 2009
•
Nasopharyngeal Carcinoma (NPC)
•
Accounts for 18% of all cancers in China; Global market of approx. $50-200 million
2
27
EFTA00506096
EPB-510 for Hepatitis C (HCV)
Preclinical Nucleotide
Polymerase Inhibitor (NPI) Program
propar*CoebteVal
...3.104.0.11aget
28
EFTA00506097
EPB-510 is a highly differentiated approach to
HCV Nucleotide Polymerase Inhibitors (NPIs)
•
Recent data from 2012 AASID confirm the critical role NPIs will play as the cornerstone
of future DAA therapies for HCV
•
HCV nucleotide polymerase inhibitors have clustered around a narrow set of structures
based primary on 2'-substituted ribose
•
Very limited IP room to operate
•
Members of this class have been withdrawn because of toxicity and/or lack of activity
•
However, acyclic nucleosides have a long history of success and safety in the clinic as
antiviral agents against herpes virus, HIV, and HBV
•
Valtrex, acyclow, & Famvir
•
Epiphany is developing EPB-510 as the first acyclic nucleotide polymerase family to
target HCV
•
Epiphany controls IP around EPB-510, a new class of nucleotide-like polymerase inhibitors
•
Combination of novel scaffold and pro-drug technology
•
Orally bioavailable pro.drug designed to be liver targeting
29
29
EFTA00506098
EPB-510 has an highly competitive in vitro & in vivo
profile for an HCV NPI
100
Discovery & Development
•
Epiphany discovered ENS-510 as part of its Internal analogue
development program
Competitive activity profile
•
EPB-510 has sub-pM in vitro HCV repl icon activity
•
Rang of actmtrmry similar to other UPIs enduring GS.7977
•
Series Is equipotent against GT la & lb
•
Unique resistance pattern compared to G5-7977 & INX-08189
•
5282T muldon associated with resistance to T-C-rnethylated compounds
(2*CrneCI
•
Myntmal loss of actmty apest 528211455P mutant ICU regimens
Excellent Pit and safety profile
•
EPB-510 is orally bioavailable and well-tolerated In vivo
•
Achieves plasma levels well in excess of therapeutic dose (ECso)
•
Metabolitefs) derived from pro-drug highly unlikely to pose toxicity
Issue
ä
3
10 «
al
'ZOO
21000
IT. gee
E
g
200
0
Resistance
Mutant
Acthnly
84621
TOW Cre
30
EFTA00506099
EPB-510 Value Proposition
New NPI's are desired for HCV
•
Next-generation HCV DAA cocktails will likely utilize an NPI
•
Well-established comparables for preclinical and clinical stage NPIs
EPB-510 has a competitive NPI profile
•
Unique and differentiated approach to NPIs
•
EPB-510 has excellent HCV replicon NPI activity
•
Preliminary in vitro pharmacology and toxicity studies complete
•
Scalable synthetic route developed
Clear route to clinic
•
IND-enabling studies can be completed in approximately 6 months
•
Proof-of-Concept Phase lb in approximately 9.10 months after IND
Strategic objective
•
Following positive Phase lb data, seek licensing partner for development through Phases 2 & 3 or
sell asset
31
EFTA00506100
Epiphany Biosciences Corporate Highlights
=
Milestones, Team, &
Value Proposition
31 ___
IIIM
32
EFTA00506101
Anticipated Value-Driving Milestones
EPB-348
Ph26/3 Shingles Pain Trial
Ph/ EBV.Transplant Trial
Ph2 EBV.Autoimmune Trul
EPB-510
Ph la/b HCV Trial
P2INITni MIMS
I
P2bIn %kW ta
KO Mein La*
CMGTMCad
Eatrats.CHsianarstar0
03V.Trae Only, OvaCgari
P2 'AVM/din
EBY ktahrnne P2TNl by
PlatialhdalCV
EAU 2016 creowno
Mitch: Dr
FIOLHIPowih
Q4 2013
Q12014
Q22014
Q32034
Q42014
33
EFTA00506102
Epiphany has a very experienced team
•
Fred Volirtsky, MD, Founder, Chairman & CEO
.
Co-founded Colherix (acquired by Actelion for S430m); member Ballard Life Science Fund LAB
•
Previously Managing Director at ACT BioYentures
•
Held Directorships at Myornetrix,Ckterie Pharma, Imagine Pharma, Kerberos Proximal Solutions, Catalyst Biosdences
•
Former faculty member at Harvard Department of Emergency Medicine
•
Howard I. Woman, MD, Chief Medieol & Seientific Consultant (Prof. of Medicine, Pathology, Cell Biology, Columbia University'
•
Steven Day, PhD, Director of Chemistry ( 15. years of drug discovery & development experience- Kosan Biosciences)
•
Curtis Saibner, MD, MBA, Regulatory Affairs 127+ years regulatory covalence; former Medical Officer & Dep. Director at FDA)
•
Paul Flyer, PhD, Dinka( Stan sacs 135• years of statistical experience - FDA, Amgen, Biogen Ides. ICOS)
•
Solomon Tse, PhD, Chemistry, Manufacturing, & Controls (30• years OMC experience- MJ)
•
Dan Szeto, PhD, OA/QC pa years QC/QA/GMP/GLP operations experience - Elan)
•
Chin-doing Lin, PhD, PrechhicalDevercipment (35• years preclinical development experience - YaleaM,101. ScheringPloughl
•
Michael Farber, PhD, JD, Mtellectual Property (27+ years IPexperience, Partner at Ditthavong Mod & Steiner)
Senior Advisory Board
•
Robert Gallo, MD, Founder & SAB Chairman (Co-discoverer of HIV Lasker Award Laureate; Founder & Director of HIV)
•
Roger Komberg, PhD, (2006 Nobel Laureate in Chemistry, Tem Board Member, Prof. Stanford University)
•
Yuan Chang, MD. (Discoverer of two of the seven known human cancer viruses, Universityof Pittsburgh Cancer Institute)
34
34
EFTA00506103
2013-08-22
Epiphany Biosciences' Value Proposition
•
Late-stage clinical antiviral company with two attractive, high-potential candidates
•
EPB-348 is a proven drug candidate with multiple "shots-on-goal"
• Safe and effective small molecule with broad spectrum antiviral activity
• Pin competition for unmet medical needs
• No antiviral approved for shingles associated pain
• No approved antivirals for EBV
• Paradigm-changing therapeutic approach to a variety of serious diseases, intl. orphan indications
•
EPS-510 is a Nucleotide Polymerase Inhibitor (NPI) for HCV with a highly competitive
preclinical profile versus other high profile leading NPIs
•
Streamlined and efficient development and clinical plans
•
Able to achieve major value-inflection points in multiple clinical programs in
approximately 1.2 years
•
Highly experienced team with track record of success
35
Add spreadsheet details
35
EFTA00506104
2013-08-22
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36
EFTA00506105
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