View:
Download DOC
Download PDF
Download XLS
Free Writing Prospectus
September 2013
Issuer Free Writing Prospectus
Filed pursuant to Rule 433
Registration No. 333-188838
August 30, 2013

Forward-Looking Statements
2
This
presentation
includes
statements
that
are,
or
may
be
deemed,
“forward-looking
statements.”
In
some
cases
these
forward-looking
statements
can
be
identified
by
the
use
of
forward-looking
terminology,
including
the
terms
“believes,”
“estimates,”
“anticipates,”
expects,”
“plans,”
intends,”
“may,”
“could,”
“might,”
“will,”
“should,”
“approximately,”
“potential,”
or
in
each
case,
their
negative
or
other
variations
thereon
or
comparable
terminology,
although
not
all
forward-looking
statements
contain
these
words.
They
appear
in
a
number
of
places
throughout
this
presentation
and
include
statements
regarding
our
intentions,
beliefs,
projections,
outlook,
analyses
or
current
expectations
concerning,
among
other
things,
the
gastroparesis
patient
market
size
and
market
adoption
of
EVK-001
by
health
care
providers
and
patients,
the
timing
and
cost
of
Phase
3
trials
for
EVK-001
or
whether
such
trials
will
be
conducted
at
all,
completion
and
receiving
favorable
results
of
Phase
3
trials
for
EVK-001,
the
development
and
approval
of
the
use
of
EVK-001
for
additional
indications
or
in
combination
therapy,
the
use
of
the
proceeds
from
this
offering,
FDA
approval
of,
or
other
regulatory
action
with
respect
to,
EVK-001,
the
timing,
cost
or
other
aspects
of
the
commercial
launch
ofEVK-001
and
the
commercial
launch
and
future
sales
of
EVK-001
or
any
other
future
products
or
product
candidates.
By
their
nature,
forward-looking
statements
involve
risks
and
uncertainties
because
they
relate
to
events,
competitive
dynamics,
and
healthcare,
regulatory
and
scientific
developments
and
depend
on
the
economic
circumstances
that
may
of
may
not
occur
in
the
future
or
may
occur
on
longer
or
shorter
timelines
than
anticipated.
Although
we
believe
that
we
have
a
reasonable
basis
for
each
forward-looking
statement
contained
in
this
presentation,
we
caution
you
that
forward-looking
statements
are
not
guarantees
of
future
performance
and
that
our
actual
results
of
operation,
financial
condition
and
liquidity,
and
the
development
of
the
industry
in
which
we
operate
may
differ
materially
from
the
forward-looking
statements
contained
in
this
presentation
as
a
result
of,
among
other
factors,
the
factors
referenced
in
the
“Risk
Factors”
section
of
the
prospectus
contained
in
the
Amendment
No.
4
to
our
Registration
Statement
of
Form
S-1
filed
with
the
Securities
and
Exchanged
Commission
on
August
30,
2013
for
our
proposed
initial
public
offering
(the
“Registration
Statement”).
In
addition,
even
if
our
results
of
operation,
financial
condition
and
liquidity,
and
the
development
of
the
industry
in
which
we
operate
are
consistent
with
the
forward-looking
statements
contained
in
this
presentation,
they
may
not
be
predictive
of
results
or
developments
in
future
periods.
Any
forward-looking
statement
that
we
make
in
this
presentation
speaks
only
as
of
the
date
of
such
statement,
and
we
undertake
no
obligation
to
update
such
statements
to
reflect
events
or
circumstances
after
the
date
of
this
presentation.
You
should
read
carefully
the
factors
described
in
the
“Risk
Factors”
section
of
the
prospectus
contained
in
the
Registration
Statement
to
better
understand
the
risks
and
uncertainties
inherent
in
our
business
and
underlying
any
forward-looking
statements.

Free Writing Prospectus Statement
3
This
presentation
highlights
basic
information
about
us
and
the
offering.
Because
it
is
a
summary,
it
does
not
contain
all
of
the
information
that
you
should
consider
before
investing.
We
have
filed
a
registration
statement
(including
a
prospectus)
with
the
SEC
for
the
offering
to
which
this
presentation
relates.
The
registration
statement
has
not
yet
become
effective.
Before
you
invest,
you
should
read
the
prospectus
in
the
registration
statement
(including
the
risk
factors
described
therein)
and
other
documents
we
have
filed
with
the
SEC
for
more
complete
information
about
us
and
the
offering.
You
may
get
these
documents
for
free
by
visiting
EDGAR
on
the
SEC
Web
site
at
http://www.sec.gov.
The
preliminary
prospectus,
dated
August
30,
2013,
is
available
on
SEC
Web
site
at
Alternatively,
we
or
any
underwriter
participating
in
the
offering
will
arrange
to
send
you
the
prospectus
if
you
contact
Aegis
Capital
Corp.,
Prospectus
Department,
810
Seventh
Avenue,
18th
Floor,
New
York,
NY
10019,
telephone:
212-813-1010,
e-mail:
prospectus@aegiscap.com.

Initial Public Offering Summary
4
Shares Offered
Over-Allotment
Price Range
Exchange / Ticker
Use of Proceeds
Sole Book Runner
2,100,000 (100% Primary)
15% or 315,000 (100% Primary)
$12.00 -
$14.00
NASDAQ Capital Market / EVOK
Clinical development of EVK-001 and other general corporate purposes
Aegis Capital Corp.
Issuer
Evoke Pharma, Inc.

Management
•
Dave Gonyer, R.Ph. –
President & CEO, Founder, 
and Director
–
26 years of pharmaceutical experience in both      
commercial and product development
–
Eli Lilly & Company, Dura Pharmaceuticals (sold to
Elan),  Xcel Pharmaceuticals (co-founder and sold to
Valeant), and Victory Pharmaceuticals (sold to
Shionogi)
•
Matt D’Onofrio, MBA –
Chief Business Officer 
and Founder
–
21 years of pharmaceutical experience in commercial
roles and execution of strategic partnerships/equity
transactions in the US and ex-US
–
Eli Lilly & Company, Vertex, and Victory
Pharmaceuticals (sold to Shionogi)
5
Board of Directors
Cam Garner (Chairman)
Past and current founder, CEO and
chairman of  several pharma companies
Todd Brady, M.D., Ph.D.
President and CEO of Aldexa Therapeutics
Ken Widder, M.D.
Former CEO and founder of Santarus, Inc.
General Partner Latterell Venture Partners
Scott Glenn
Past CEO of Quidel Corp. and chairman or
founder of several pharma companies
Malcolm Hill, Pharm.D.
Co-founder and Chief Scientific Officer at
Meritage Pharma
Ann Rhoads
Executive Vice President  and Chief
Financial Officer at Zogenix , Inc.

Investment Highlights
6
Nasal Delivery Improves
Standard of Care for
Gastroparesis
Capital Efficient and
Risk Mitigated
Clinical Development
Large Commercial
Opportunity with Limited
Competitive Development
•
One successful pivotal trial completed
•
Single Phase 3 clinical trial required for NDA submission
•
Clinical enhancement of the only currently approved molecule for
gastroparesis and 30+ years of medical use
•
Potentially 12-16 million patients with symptoms of gastroparesis
•
Only one approved product on the market for the treatment of
gastroparesis and few products in development
•
Two key granted US patents to 2030; PCT application to 2032
•
Gastroparesis is common, serious, and currently poorly treated
•
Intranasal delivery avoids GI absorption concerns for patients with
compromised motility
•
Predictable absorption regardless of gastric emptying delay and relief
of symptoms even during flares

Gastroparesis Diagnosis & Symptoms
Simpson, S.E., Clinical Toxicology, 2011
Gastroparesis is a
disorder in which
the stomach is
delayed in emptying
its contents to the
small intestine
Undissolved drug tablets in a stomach
Potentially 12-16 million patients with gastroparesis
symptoms in the US and over 80% are women
7
Characteristic
symptoms are
nausea,
vomiting,
abdominal pain,
early satiety,
and bloating
Gastroparesis
interferes with
GI absorption of
food and
medications due
to unpredictable
gastric emptying
and vomiting
Symptom flares
vary in severity
and diminish
quality of life,
negatively impact
blood glucose
control, and lead
to complications
requiring
hospitalization

Our novel approach under development for the relief of symptoms
associated with acute & recurrent diabetic gastroparesis in women
8
EVK-001
(Intranasal Metoclopramide)
Sites of drug spray and
absorption
Intranasal delivery bypasses
the gastrointestinal tract
and directly enters the
bloodstream unlike oral
medications
Intended to provide predictable
absorption regardless of gastric
emptying delays; Intended to
provide symptom relief even
during flares

Head to Head Phase 2 Diabetic Gastroparesis Clinical
Data (Oral Metoclopramide v. Intranasal Metoclopramide)
Mean Total Symptom Score (TSS) Change
from Baseline to Week 6
Statistically significant improvement in total symptom score for
intranasal
doses versus 10 mg oral confirms benefit of intranasal vs. oral
Metoclopramide for Diabetic Gastroparesis:: Comparison of a Nasal Spray Formulation to Conventional Oral Tablet Administration
Henry P. Parkman, MD,  Temple University, School  of Medicine
Presented at DDW 2013 (Orlando, FL)
9

Gastroparesis Development Landscape
Product
Class
Route
Company
Development
Status
EVK-001
Dopamine antagonist/ mixed
5-HT
3
antagonist/5-HT
4
agonist
Intranasal
Evoke Pharma
Phase 3 Ready
RM-131
Ghrelin agonist
Sub
Cutaneous
Rhythm
Therapeutics
Phase 2
GSK962040
Motilin agonist
Oral
GlaxoSmithKline
Phase 2a
TD-5108
5-HT
4
agonist
Oral
Theravance
Phase 2a
No new competition expected for several years after EVK-001 launch
even if new chemical entities prove effective
10

Metoclopramide Nasal Spray (EVK-001) for Diabetic
Gastroparesis
11
•
US multicenter, double-blind, placebo-controlled study
•
287 patients with diabetic gastroparesis
•
4-week safety and efficacy study
•
3 treatment arms (placebo, 10 mg and 14 mg)
•
Patient Reported Outcome (PRO) primary endpoint: modified Gastroparesis
Cardinal Symptom Index -
Daily Diary (mGCSI-DD)
–
Four symptom composite: nausea, early satiety, bloating, upper abdominal pain
–
Total score change from baseline to week 4
Completed Phase 2b study (METO-IN-002)
METO-IN-002 is currently the largest diabetic gastroparesis
study conducted with metoclopramide

METO-IN-002 Efficacy Results: Statistical Significant
Improvement of Symptoms of Gastroparesis in Women
Mean mGCSI-DD Total Score Change
from Baseline to Week 4 for Females
•
METO-IN-002 revealed a gender difference not previously detected in smaller gastroparesis  studies
•
Gender effects have been reported in drug studies for other GI motility disorders, such as IBS, and
products approved for women only indications
•
Statistically significant difference
between EVK-001 and placebo
(p<0.02) for the pre-specified
analysis group of females (n=203)
•
Results not significant for ITT
population due to lack of separation
from placebo in males
Summary of Phase 2b Study
12

Composite Endpoint
Nausea*
Retching
Vomiting
Stomach Fullness
Early Satiety*
Feeling Full
Loss of Appetite
Bloating*
Stomach Larger
Upper Abdominal Pain*
Upper Abdominal Discomfort
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
0.8
1
1.2
METO-IN-002: Gender Disparity in Treatment Effects of
EVK-001 vs. Placebo
Favors Treatment
Favors Placebo
= Women
= Men
*mGCSI-DD = four bolded symptoms.  Differences of least-square means of 10 mg treatment scores, 95% confidence intervals
Efficacy outcomes show
consistent benefit for women
across all symptoms
13

METO-IN-002: Favorable Safety Profile
14
•
EVK-001 was well-tolerated at both
the 10 mg and 14 mg doses QID for
28 days
•
<10% dropouts, includes 5% due to
adverse events (AEs)
•
Majority of AEs were mild/moderate
and transient in nature
•
No significant cardiac changes
throughout 28-day treatment period
•
No SAEs reported related to study
drug
Summary of Data
Treatment-Emergent Adverse Events Reported by
More than 2 Subjects in Any Treatment Group
Placebo
(N = 95)
EVK-001 10 mg IN
(N = 95)
EVK-001 14 mg IN
(N = 95)
Dysgeusia*
4 (4.2%)
12 (12.6%)
13 (13.7%)
Headache
4 (4.2%)
7 (7.4%)
8 (8.4%)
Dizziness
2 (2.1%)
3 (3.2%)
3 (3.2%)
Somnolence
0 (0.0%)
2 (2.1%)
2 (2.1%)
Fatigue
1 (1.1%)
5 (5.3%)
6 (6.3%)
Depression
3 (3.2%)
0 (0.0%)
0 (0.0%)
Diarrhea
9 (9.5%)
3 (3.2%)
2 (2.1%)
Nausea
4 (4.2%)
1 (1.1%)
4 (4.2%)
GERD
1 (1.1%)
4 (4.2%)
0 (0.0%)
Epistaxis
0 (0.0%)
2 (2.1%)
3 (3.2%)
Cough
2 (2.1%)
0 (0.0%)
3 (3.2%)
Nasal discomfort
0 (0.0%)
3 (3.2%)
2 (2.1%)
Rhinorrhea
1 (1.1%)
1 (1.1%)
3 (3.2%)
Throat irritation
1 (1.1%)
0 (0.0%)
3 (3.2%)
Upper resp. tract inf.
4 (4.2%)
0 (0.0%)
2 (2.1%)
Nasopharyngitis
1 (1.1%)
3 (3.2%)
1 (1.1%)
Hyperglycemia
1 (1.1%)
1 (1.1%)
3 (3.2%)
Hypoglycemia
1 (1.1%)
1 (1.1%)
3 (3.2%)
* Of the subjects reporting dysgeusia, 34% were from one site

End of Phase 2 Regulatory Guidance
•
Required for NDA filing
–
Single Phase 3 study in women only
•
Dose, regimen, duration (10 mg, QID, and 28 days), and endpoint
–
Thorough QT study
•
Despite the absence of cardiac safety issues with metoclopramide
•
Not required for NDA filing
–
Parallel study in men with futility stop based on efficacy
–
Safety results will be included in female NDA
15

Planned Phase 3 Study for EVK-001
16
Protocol
Objective
Primary
Endpoint
•
Double-blind, placebo-controlled, parallel-group study to
evaluate the efficacy, safety and population
pharmacokinetics in adult female subjects with diabetic
gastroparesis
•
Two treatment arms
–
EVK-001 10 mg or placebo before meals and at bedtime for 28 days
•
~200 total subjects (1:1 randomization)
•
~60 U.S. sites
•
Demonstrate safety and effectiveness of metoclopramide
nasal spray versus placebo in reducing the symptoms of
gastroparesis
•
Change in the average GSA total score for baseline versus
Week 4 of the treatment period
Phase 3 study design very similar to Phase 2b design

Planned Development Timeline
Top-Line
Data
TQT Study
METO-IN-003 (female study)
Pivotal Phase 3
Top-Line
Data
METO-IN-004 (male study)
Not Required for NDA Filing
17

Compelling Commercial Opportunity
•
Physician market research indicates significant need and positive
feedback for EVK-001
–
Gastroenterologists, Internal Medicine, and Primary Care
–
Over 300 physicians
•
Payer and pricing research shows potential rapid market uptake
–
Large and mid size plans
–
Medical and pharmacy directors
•
Patient market research shows comfort and interest with nasal delivery
•
Currently large prescription and patient volume in gastroparesis
–
Approximately 5 million metoclopramide prescriptions treating part of the market
–
Potentially 12-16 million US patients with symptoms of gastroparesis
18

US Gastroparesis Population is Large and Growing
19
•
Potentially 12-16  million patients with symptoms of
gastroparesis
•
Many patients go untreated
•
Samsom M, Roelofs J. “Prevalence of Delayed Gastric Emptying in Diabetic Patients and Relationship to Dyspeptic Symptoms.”
Diabetes
Care,
Vol.
26,
No.
11,
Nov.
2003,
3116-3122.
•
Hasler
WL.
Current
Gastro
Reports
2007;9:
261-2692007;9:
270-279
•
Intagliato
NI,
Koch
KL.
Current
Gastro
Reports
•
Soykan I, Sivri B, Sarosiek I, Kiernan B, McCallum RW. Demography, clinical characteristics, psychological and abuse profiles,
treatment,
and
long-term
follow-up
of
patients
with
gastroparesis.
Dig
Dis
Sci
1998;43:2398-404.
80%
80%
80% of all patients diagnosed
with gastroparesis are women

14%
17%
15%
38%
41%
39%
5%
8%
6%
0%
25%
50%
75%
100%
Overall, High
Overall, Medium
Overall, Total
Reglan
Generic Oral Metoclopramide
Metozolv
Metoclopramide Share
50% -
80% of Patients Are Already Treated with Metoclopramide,
Trending Higher in Moderate to Severe Patients
20
Mild to moderate patients
Moderate to severe patients
14%
20%
15%
47%
50%
48%
6%
9%
7%
0%
25%
50%
75%
100%
Overall, High
Overall, Medium
Overall, Total
(oral dissolving metoclopramide)
Source:
ZS
Associates
Gastroparesis
quantitative
survey
(n=121),
Questions
3Q30
and
3Q37:
What
percent
of
your
mild
to
moderate
/
moderate
to
severe
gastroparesis
patients
are
being
managed
with
each
of
the
following
options?
Your
percentage
can
sum
to
over
100%
if
patients
are
receiving
more
than
one
therapy.
Totals
weighted
based
on
average
metoclopramide
TRx’s
per
high/medium
segment

5.3
5.5
5.5
1
7
I am concerned about the absorption of oral
medication in my gastroparesis patients
I am concerned about patients absorbing
medication due to vomiting
I am concerned about safety issues associated
with the delayed absorption and the potential
of multiple medications administered
throughout the day
View of Current Medications
Physicians Are Not Satisfied with Current Treatment Options
Source: ZS Associates Gastroparesis quantitative survey (n=121 3Q43: How much do you agree with each of the following
statements? 
There is a need in
gastroparesis treatment
for other options
21
(Completely Disagree)
(Completely Agree)

5.8
5.9
6.2
5.9
5.9
6.1
5.8
5.9
6.1
1
7
IN delivery may improve absorption of
metoclopramide vs oral
IN delivery may provide faster absorption
compared to oral
IN metoclopramide may allow patients with
vomiting to absorb the medication
Total
GE
PCP
Mode of Delivery Attributes
22
(Completely Disagree)
(Completely Agree)
MDs’
Concerns Regarding Absorption of Medication Are
Addressed by EVK-001’s Base Product Profile
Source:
ZS
Associates
Gastroparesis
quantitative
survey
(n=121),
Question
4Q5:
How
much
do
you
agree
with
each
of
the
following
statements?
Totals
weighted
based
on
average
metoclopramide
TRx’s
per
high/medium
segment

Source: G&S Research, May 2011.  N = 98.  All previously diagnosed with diabetic gastroparesis and enrolled in METO-IN-002.
Questions: 31, 37, 38, 35
Gastroparesis Patients Have Previous Experience, Prefer Nasal
Delivery and Will Use It If Prescribed
23
Patient Preferences

EVK-001 Payer Reimbursement Landscape
SE = electronic step edit
PA = prior authorization
QL = quantity limits
Commercial Predicted Formulary Access of EVK-001
(n = 10;  104M total US lives represented)
Increasing price points
Source: ICON / Pricespective, EVK-001Payer Landscape for Gastroparesis July 2012
As the majority of patients are already on generic metoclopramide, a step edit
is projected to have minimal market share loss at highest price point tested
24

Limited Treatment Options for Gastroparesis Creates
Underserved and Large Market
25
Metoclopramide
(generic)
Oral & IV
Propulsid
®
(cisapride)
5-HT
4
Agonist/
5-HT2
B
Antagonist
Zelnorm
®
(tegaserod)
5-HT
4
Agonist/
5-HT2
B
Antagonist
•
Only approved product approved in
the US for diabetic gastroparesis
•
Boxed warning in 2009
•
~ 5 M Rx’s/year
•
Not approved for gastroparesis
•
Rx’ed for upper GI motility disorders
•
~ $1B peak sales
•
Not approved for gastroparesis
•
Rx’ed for upper GI motility disorders
•
~ $500M peak sales
Withdrawn from market
in 1999 for cardiac issues
Withdrawn from market
in 2007 for cardiac issues
•
Other drugs used for treatment of gastroparesis symptoms include:  Domperidone (not
approved in the US), anti-
emetics, erythromycin, and opioids
First line treatment (AGA guidelines)

EVK-001 Intellectual Property Summary
26
IP Landscape
•
Two (2) key issued U.S.
patents covering method
of use and formulation
•
Two (2) granted foreign
patents covering method
of use
•
One (1) pending U.S.
patent application
U.S. Granted Patents
Patent #
U.S. 6,770,262
U.S. 8,334,281
Title
Nasal Administration of Agents for
the Treatment of Gastroparesis
Nasal Formulations of
Metoclopramide
Expires
2021
2030
PCT Application
Application #
PCT/US2012/052096
Title
Treatment of Symptoms Associated with Female
Gastroparesis
Expires
2032 (if granted)
Current patents provide protection against:
•
delivering metoclopramide into the nose to treat symptoms associated gastroparesis; and
•
using a spectrum of stable liquid formulations containing metoclopramide

Valuation Comparables
Company
Stage
Asset
Valuation
Evoke Pharma
(EVOK)
Phase 3
Optimized drug for Gastroparesis
$77M
(post midpoint money)
Synergy Pharma
(SYGP)
Phase 3
NCE for IBS
$400M
Ironwood Pharmaceuticals
(IRWD)
Commercial
NCE for IBS
$1.2B
Santarus
(SNTS)
Commercial
Optimized drug for Crohn’s &
GERD
$1.7B
NPS Pharmaceuticals
(NPSP)
Commercial
NCE for Short Bowel Syndrome
$2.1B
27

Pre-IPO Capital Structure
Capitalization
Shares Outstanding
% Outstanding
Common Stock
3,681,752
96.20%
Stock
Options
1
123,250
3.22 %
Warrants
2
22,000
0.57 %
Fully-diluted Shares Outstanding
3,827,002
100 %
28
1
Average
strike
price
of
$0.40
2
Average
strike
price
of
$7.50

IPO –
Use of Proceeds and Next Steps
29
•
Research & Development -
$15M
–
Complete one Phase 3 clinical trial of EVK-001 for the relief of
symptoms associated with acute and recurrent diabetic gastroparesis
in adult women with diabetes mellitus
–
Complete a Thorough QT study for EVK-001
–
Begin a parallel clinical trial of EVK-001 in males
•
Remainder will be used for working capital and general
purposes

Investment Highlights
30
Nasal Delivery Improves
Standard of Care for
Gastroparesis
Capital Efficient and
Risk Mitigated
Clinical Development
Large Commercial
Opportunity with Limited
Competitive Development
•
Gastroparesis is common, serious, and currently poorly treated
•
Intranasal delivery avoids GI absorption concerns for patients with
compromised motility
•
Predictable absorption regardless of gastric emptying delay and relief
of symptoms even during flares
•
One successful pivotal trial completed
•
Single Phase 3 clinical trial required for NDA submission
•
Clinical enhancement of the only currently approved molecule for
gastroparesis and 30+ years of medical use
•
Potentially 12-16 million patients with symptoms of gastroparesis
•
Only one approved product on the market for the treatment of
gastroparesis and few products in development
•
Two key granted US patents to 2030; PCT application to 2032