FWP 1 d579993dfwp.htm FWP FWP
September 2013
Filed Pursuant to Rule 433
Registration Statement No. 333-190464
September 9, 2013


2
2
This
presentation
contains
forward-looking
statements
under
the
meaning
of
the
Private
Securities
Litigation
Reform
Act
of
1995.
These
statements
give
our
current
expectations
or
forecasts
and
use
words
such
as
“anticipate,”
“estimate,”
"expect,"
“believe,”
and
other
words
of
similar
meaning.
Any
or
all
of
the
forward-looking
statements
in
this
presentation
may
turn
out
to
be
wrong.
They
can
be
affected
by
inaccurate
assumptions
we
might
make
or
by
known
or
unknown
risks
and
uncertainties
including
but
not
limited
to,
the
efficacy
of
our
product
candidates,
their
efficacy
at
acceptable
dosage
levels,
the
ability
to
raise
capital
when
needed
and
on
reasonable
terms,
projections
of
potential
commercial
sales
of
company
products,
the
results
and
progress
of
clinical
trials,
developing
the
necessary
manufacturing
processes
and
gaining
all
necessary
regulatory
approvals,
both
in
the
United
States
and
internationally.
Consequently,
no
forward-looking
statement
can
be
guaranteed
and
actual
results
may
differ
materially.
Additional
information
concerning
factors
that
could
cause
actual
results
to
materially
differ
from
those
in
the
forward-looking
statements
are
contained
in
our
most
recent
reports
to
the
Securities
and
Exchange
Commission
including
our
Form
10-Q,
8-K
and
10-K
reports.
However,
we
undertake
no
obligation
to
publicly
update
forward-looking
statements,
whether
as
a
result
of
new
information,
future
events
or
otherwise.
We
note
these
factors
for
investors
as
permitted
by
the
Private
Securities
Litigation
Reform
Act
of
1995.
The
information
in
this
document
has
been
prepared
solely
for
informational
purposes
and
does
not
constitute
an
offer
to
sell
or
the
solicitation
of
an
offer
to
purchase
any
securities
from
any
entities
described
herein.
Any
such
offer
will
be
made
solely
by
means
of
the
prospectus
contained
in
the
registration
statement
(the
"Registration
Statement")
filed
by
OXiGENE,
Inc.
(the
"Company")
with
the
Securities
and
Exchange
Commission
(the
"SEC").
The
information
contained
herein
may
not
be
used
in
connection
with
an
offer
or
solicitation
by
anyone
in
any
jurisdiction
in
which
such
offer
or
solicitation
is
not
permitted
by
law
or
in
which
the
person
making
the
offer
or
solicitation
is
not
qualified
to
do
so
or
to
any
person
to
whom
it
is
unlawful
to
much
such
offer or solicitation.
INVESTING
IS
SPECULATIVE
AND
INVOLVES
RISK
OF
LOSS.
YOU
SHOULD
REVIEW
CAREFULLY
THE
REGISTRATION
STATEMENT,
INCLUDING
THE
DESCRIPTION
OF
THE
RISKS
AND
OTHER
TERMS
BEFORE
MAKING
A
DECISION
TO
INVEST.
The
Company
has
filed
a
Registration
Statement
(including
a
prospectus)
with
the
SEC
for
the
offering
to
which
this
presentation
relates.
Before
you
invest,
you
should
read
the
prospectus
contained
in
the
Registration
Statement,
the
information
incorporated
by
reference
into
the
Registration
Statement,
and
other
documents
the
Company
has
filed
with
the
SEC
for
more
complete
information
about
the
Company
and
the
offering.
You
may
get
these
documents
for
free
by
visiting
EDGAR
on
the
SEC
website
at
http://www.sec.gov
Alternatively,
the
Company
or
the
placement
agent
participating
in
the
offering
will
arrange
to
send
you
the
prospectus contained in the Registration Statement if you request it by calling H.C. Wainwright & Co., LLC at (212) 356-0500.
Safe Harbor And Free Writing Prospectus Statement
Safe Harbor And Free Writing Prospectus Statement


OXiGENE, Inc. (OXGN) Corporate Snapshot
OXiGENE, Inc. (OXGN) Corporate Snapshot
Development-stage biotechnology company
Lead
product
candidate:
ZYBRESTAT
®
A vascular disrupting agent (VDA) being developed
primarily as an adjunctive cancer therapy which
has shown utility and tolerability to date in
combination
with
Avastin
®
and other cancer drugs
for ovarian cancer and other solid tumors
Follow-on product: OXi4503
A
2
nd
generation,
dual-mechanism
VDA
being
developed for acute myeloid leukemia (AML)
Robust intellectual property (IP) portfolio
consists of more than 120 patents worldwide
3


OXiGENE Leadership Team
OXiGENE Leadership Team
4


5
5
After many years of research,
After many years of research,
we believe ZYBRESTAT
we believe ZYBRESTAT
®
®
may
may
become the first
become the first
commercialized VDA…
commercialized VDA…
*
*
*


6
6
attracting the support of
attracting the support of
numerous prestigious
numerous prestigious
foundations, non-profit
foundations, non-profit
research institutions and “big
research institutions and “big
pharma”
pharma”
companies.
companies.
*
*


7
7
Where is the Opportunity?
Where is the Opportunity?
Significant Therapeutic and Commercial Potential
Potential to significantly improve outcomes in solid tumor indications
Example: Antisoma received $75M upfront and $915 M in potential
development-based milestones for ASA404 from Novartis
Challenging Development History Limits Competition
Apart from OXiGENE only 3 other companies are known to be currently
developing
VDAs,
none
of
which
have
progressed
to
the
submission
stage
OXiGENE
believes
it
has
determined
the
optimal
way
ZYBRESTAT
®
should be developed and brought to the market
ZYBRESTAT
®
May Become the First Commercialized VDA
Clinically
meaningful
activity
with
no
significant
safety
issues
to
date
Previously identified cardiovascular response was found to be easily
managed with no abrogation of the anti-tumor effects


8
8
OXiGENE’s
OXiGENE’s
ZYBRESTAT
ZYBRESTAT
®
®
(fosbretabulin,
(fosbretabulin,
CA4P)
CA4P)
Established Safety Profile (>400 patients)
No cumulative toxicities or cytotoxic-like side-effects
Manageable, transient mild-to-moderate hypertension
Manageable, transient myelosuppression with chemotherapy
Demonstrated Vascular Disrupting Activity
Single agent activity with partial and complete responses in solid tumors
Positive
results
in
combination
with
Avastin
®
(bevacizumab)
Positive
results
in
combination
with
Paraplatin
®
/
Taxol
®
Robust Intellectual Property (IP)
Protected by both composition-of-matter and method-of-use patents
Exclusive, worldwide license to the combretastatins discovered and
isolated by researchers at Arizona State University (ASU)


9
9
Unique, Dual Mechanism of Action
Tubulin-mediated cell shape change of endothelial and leukemic cells
Metabolized by oxidative enzymes (e.g., tyrosinases and peroxidases)
into an orthoquinone species with direct cytotoxic effects on tumor cells
Compelling Preclinical and Early Clinical Data
Recommended dose, objective responses and significant blood flow
reductions shown in Ph 1/2 studies in refractory solid tumors
Demonstrated near-complete elimination of FLT-3 mutated human AML
(leukemic clone) in systemic xenograft in SCID mouse model
Robust Intellectual Property (IP)
Protected by both composition-of-matter and method-of-use patents
Exclusive, worldwide license to the combretastatins discovered and
isolated by researchers at Arizona State University (ASU)
OXiGENE’s OXi4503: A 2nd-Generation VDA
OXiGENE’s OXi4503: A 2nd-Generation VDA


10
10
OXiGENE’s Late-Stage Development Pipeline
OXiGENE’s Late-Stage Development Pipeline
ZYBRESTAT
®
Combination Therapy
Preclinical
Phase 1
Phase 2
Phase 3
With Paraplatin
®
(carboplatin) / Taxol
®
(paclitaxel) in anaplastic thyroid cancer
(ATC)
With Avastin
®
(bevacizumab) in ovarian
cancer
With Votrient
®
(pazopanib) in ovarian
cancer
With Taxol
®
(paclitaxel) in ovarian cancer
ZYBRESTAT
®
Single-Agent Therapy
Preclinical
Phase 1
Phase 2
Phase 3
Carcinoid syndrome
OXi4503 Single-Agent Therapy
Preclinical
Phase 1
Phase 2
Phase 3
Refractory acute myelogenous leukemia
(AML)
Ph. 2/3 completed
Ph. 2 ongoing
Ph. 2 planned
Ph. 2 planned
Ph. 1 ongoing
Ph. 1b/2 planned
Pre-EU MAA


11
11
OXiGENE (OXGN) Investment Thesis
OXiGENE (OXGN) Investment Thesis
Compelling Valuation
Currently trading at a market cap of less than $10 million
Leveraging $200+ million previously invested primarily in VDA development
Cost-Efficient and Risk-Mitigated Development Strategy
Ongoing and planned Ph 2 trials supported by foundations, non-profit research
institutions and larger pharmaceutical companies
Significant Potential Value-Creating Events on the Horizon
Enrollment complete for ongoing Avastin
®
+/-
ZYBRESTAT
®
Ph 2 in ovarian
cancer; Preliminary results expected 1H14
Potential initiation of Taxol
®
+/-
ZYBRESTAT
®
and Votrient
®
+/-
ZYBRESTAT
®
Ph 2 trials in ovarian cancer, as well as a Ph 1a/2b trial in carcinoid syndrome
Completion of enrollment for OXi4503 Ph 1 trial in AML
Actively pursuing development and commercialization agreements with
established industry leaders


12
12
Vascular Disrupting
Vascular Disrupting
Agents (VDAs)
Agents (VDAs)
Denying Tumors Oxygen
Denying Tumors Oxygen
and Vital Nutrients
and Vital Nutrients
*
*
*
*
*
*
*


13
13
About Vascular Disrupting Agents (VDAs)
About Vascular Disrupting Agents (VDAs)
Proven Mechanism of Action
VDAs cut off blood supply to tumors, effectively
‘starving' them of oxygen and nutrients
Reducing blood supply is a proven mechanism
used by  commercialized anti-VEGF drugs such
as Avastin
®
(bevacizumab) to treat cancer
Targeted Impact
VDAs disrupt blood flow and vasculature only
within tumors, sparing normal cells and organs
Broad Therapeutic Utility
Potentially useful in a wide range of tumors
Potentially improve clinical outcomes when
used in combination with other types of anti-
cancer therapies
Tumor Blood Flow Before VDA
Tumor Blood Flow After VDA


14
14
Product
Developer
Partner
Status
In Active Development
ZYBRESTAT
®
OXiGENE
Unpartnered;
Licensed from 
Arizona State
University (ASU)
and BMS
Currently in pre-MAA stage for ATC in EU
Completed Ph 2b/3a with Paraplatin
®
(carboplatin) / Taxol
®
(paclitaxel) in
anaplastic thyroid cancer (ATC)
Currently in Ph 2 with Avastin
®
(bevacimuzab) in ovarian cancer
Planned Ph 2 with Votrient
®
(pazopanib) in ovarian cancer
Planned Ph 2 with Taxol
®
(paclitaxel) in ovarian cancer
Planned Ph 1/2 trial in carcinoid syndrome (IP from AngioGene)
OXi4503
OXiGENE
Unpartnered;
ASU License
Currently in Phase 1 in acute myelogenous leukemia
BNC105
Bionomics
Unpartnered
Currently in Ph 2 in combination with chemotherapy in both renal
cell and
ovarian cancers
NPI-2358
(plinabulin)
Nereus
Unpartnered
Completed Ph 1 and Ph 2 clinical trials for solid tumors and NSCLC
(combination with docetaxel); no ongoing trials
Crolibulin
EpiCept
Immune Pharma
Ltd.
Currently in Phase 1/2 in combination with cisplatin in solid tumors with
focus on ATC
No Longer in Active Development
AVE8062
Ajinomoto
SanofiAventis
Active but limited IP
ASA404
Antisoma
Novartis
Failed in Ph 3
Denibulin
AngioGene
MediciNova
Cardiac toxicity in Ph 2
ZD6126
AstraZeneca
AngioGene
Cardiac toxicity in Ph 2
VDA Competitive Landscape
VDA Competitive Landscape


15
15
ZYBRESTAT
ZYBRESTAT
®
®
Program
Program
in Ovarian Cancer
in Ovarian Cancer
*
*
*
*
*
*
*
*


16
16
Why Ovarian Cancer?
Why Ovarian Cancer?
Aggressive, stealthy cancer
~22,000 new cases in the U.S. annually,
~220,000 new cases worldwide
Over 60% of patients have distant spread
at diagnosis resulting in poor prognosis
Dire need for better therapies
Highly lethal cancer that is responsible
for the deaths of approximately 14,000
women in the U.S. each year
Rapid resistance to existing FDA-
approved treatments ultimately limits
their effectiveness
5-year survival rates of only 47%, largely
unchanged since the 1990s
Annual Incidence And Mortality Rates
of Female Cancers Worldwide
Ovarian Cancer Spread at Diagnosis


17
17
Risk-Mitigated, Cost Effective Development
Risk-Mitigated, Cost Effective Development


18
18
Avastin
Avastin
®
®
(bevacizumab) +/-
(bevacizumab) +/-
ZYBRESTAT
ZYBRESTAT
®
®
Co-Sponsored by Gynecologic Oncology Group (GOG),
National Cancer Institute (NCI), and Genentech / Roche
Ongoing Ph 2 trial (GOG186I) in ovarian cancer
First randomized combination study of Anti-VEGF + VDA compounds
2nd-
or 3rd-line therapy for platinum-resistant ovarian cancer
Primary endpoint: Median progression free survival (PFS)
Goal: Improvement  in PFS from 50% (Avastin
®
) to 65% (Combination)
Enrollment complete at 107 patients at 80+ clinical sites; preliminary
results expected 1H14
Rationale: Positive Ph 1 and preclinical trial results
Disease stabilization in 9/14 (60%) treated patients who had failed
multiple prior therapies


19
19
Votrient
Votrient
®
®
(pazopanib)
(pazopanib)
+/-
+/-
ZYBRESTAT
ZYBRESTAT
®
®
Potentially Sponsored by UK Non-Profit Cancer Research
Organization and Drug Manufacturers Involved
Planned Randomized, Placebo-controlled Ph 2 trial
Up to 120 patients with platinum-resistant ovarian cancer
Primary endpoint: Median progression free survival (PFS)
Initiation expected 1H14
Rationale: Positive Ph 1 and Preclinical Trial Results
Positive
Ph
1
results
with
Avastin
®
+
ZYBRESTAT
®
Anti-angiogenic
multi-kinase
inhibitors
+
ZYBRESTAT
®
significantly
reduced tumor growth rates in preclinical tumor models
OXiGENE’s Estimated Cost: < $1M


20
20
Weekly Taxol
Weekly Taxol
®
®
(paclitaxel) +/-
(paclitaxel) +/-
ZYBRESTAT
ZYBRESTAT
®
®
OXiGENE’s Estimated Cost: ~$1M w/ or ~$8M w/o Co-Sponsor


21
21
*
*
*
*
*
*
*
*
*
*
ZYBRESTAT
ZYBRESTAT
®
®
Program
Program
in Carcinoid Syndrome
in Carcinoid Syndrome
*
*
*
**
*
*
*


22
22
Carcinoid Syndrome
Carcinoid Syndrome
Slow-Growing, Biologically
Active GI Tumors
Neuroendocrine tumors (NETs) that
overproduce biologically active
substances such as serotonin
Causes debilitating symptoms,
including episodic flushing, diarrhea,
wheezing, and potentially carcinoid
heart disease
Limited Therapeutic Options
Somatostatin
analogues
such
as
Sandostatin
®
(octreotide)
help
to
control symptoms, but the effect is often only temporary
Non-responders are limited to surgical resection and/or chemotherapy,
for which patients are often ineligible


23
23
Sandostatin
Sandostatin
®
®
(octreotide) +/-
(octreotide) +/-
ZYBRESTAT
ZYBRESTAT
®
®
Planned Ph. 1b/2a Self-Controlled Study
20 Sandostatin
®
-refractory carcinoid syndrome patients with 
increased biomarker (5-HIAA and/or chromogranin A) levels
Primary endpoints: Biomarker (5-HIAA and/or chromogranin A) levels
Secondary endpoints: Symptom control, QoL
Rationale: Positive Preclinical Results, Potentially Rapid
Development Pathway, Robust Intellectual Property
Positive preclinical data in prolactinoma and insulinoma models
Potentially rapid readout and development based on biomarkers
Exclusive, worldwide licensing agreement with Angiogene
Pharmaceuticals for the use of VDAs in the treatment of carcinoid
syndrome and other neuroendocrine tumors (NETs)
OXiGENE’s Estimated Cost: ~$3M


24
24
ZYBRESTAT
ZYBRESTAT
®
®
Program
Program
in Anaplastic Thyroid
in Anaplastic Thyroid
Cancer (ATC)
Cancer (ATC)
*
**
*
*
*
*
*


25
25
ZYBRESTAT
ZYBRESTAT
®
®
in Anaplastic Thyroid Cancer
in Anaplastic Thyroid Cancer
Completed Randomized Ph. 2/3 (FACT) Trial Results
80 patients with biopsy-proven ATC at 40 clinical sites
Paraplatin
®
(carboplatin)
/
Taxol
®
(paclitaxel)
+/-
ZYBRESTAT
®
Primary endpoint: Median survival: 5.2 vs. 4.0 months (NS), HR 0.72
Secondary endpoints: 1-year survival 26 vs. 9%; OR rate 20 vs. 16%
Target 1H16 EMA marketing authorization in EU
Potential
for
approval
via
“Exceptional
Circumstances”
pathway
May not require additional clinical data
Anaplastic Thyroid Cancer (ATC)
Highly aggressive and lethal cancer with limited
treatment options
~2,000 total patients annually in the US and EU
Orphan drug status in both the US and EU
OXiGENE’s Estimated Cost: ~$5M remaining


26
26
Paraplatin
®
/
Taxol
®
+
ZYBRESTAT (N=55)
Paraplatin
®
/
Taxol
®
(N=25)
Median Survival
(95% CI)
5.2 months
(3.1, 9.0)
4.0 months
(2.8, 6.2)
One-year Survival
25.5%
8.7%
Hazard Ratio
(95%CI)
0.72 (0.43, 1.20)
28% Risk Reduction
Survival Time (Months)
Results from Ph 2/3 (FACT) Study in ATC
Results from Ph 2/3 (FACT) Study in ATC


27
27
OXi4503 Program
OXi4503 Program
in Acute Myelogenous
in Acute Myelogenous
Leukemia (AML)
Leukemia (AML)
*
*
*
*
*
*
*


28
28
OXi4503 in Acute Myelogenous Leukemia
OXi4503 in Acute Myelogenous Leukemia
Ongoing Ph 1 Dose-Escalation Study
Co-sponsored by the University of Florida, the Leukemia and Lymphoma
Society
Up to 36 relapsed and refractory acute myelogenous leukemia (AML) or
myelodysplastic syndrome
patients 
Primary endpoint: Recommended dose
Secondary endpoint: Hematologic responses
Rationale: Positive Preclinical Trial Results and Robust
Intellectual Property
Demonstrated near-complete elimination of FLT-3 mutated human AML
(leukemic clone) in systemic xenograft in SCID mouse model
Composition-of-matter and method-of-use patents for myeloid-lineage
leukemias


29
29
OXiGENE (OXGN)
OXiGENE (OXGN)
Corporate Summary
Corporate Summary
*
*
*
*
*
*
*
*


30
30
Financial Overview
Financial Overview
Cost-Efficient, “Virtual Company”
Infrastructure
Cash: $7.7M (2Q13), projected to last into 2Q14
Raised $6.1M in early 2013 via ATM and PIPE
Reduced expenses by more than 30% in 2012
Debt: $0M (2Q13)
Common Stock: 2.7M outstanding (6.8M fully diluted)
Prioritized Spending Needs
Avastin
®
combo (GOG0186I) in ovarian cancer (<$1M remaining)
Votrient
®
combo in ovarian cancer (<$1M in future spending)
Taxol
®
combo in ovarian cancer ($1-8M in  future spending)
EU
MAA
filing
for
Paraplatin
®
/
Taxol
®
combo
in
ATC
(~$5M,
some
of
which may be recovered via commercialization of registration lots)
Carcinoid syndrome Ph 1 program (~$3M)


31
31
Robust Intellectual Property Portfolio
Robust Intellectual Property Portfolio
ZYBRESTAT®
United States
Europe
Japan
Composition of Matter: fosbretabulin
tromethamine
September 2021
US 7659261, 7524832 &
7659262
September 2021
EPO 1320534
September 2021
JP 4149804
Method of modulating tumor growth
or metastasis by administration of fosbretabulin
and paclitaxel
December 2021
US 6,538,038
N/A
N/A
Method of treating NET including carcinoid
tumor symptoms by administering fosbretabulin
June 2033
PCT* pending
June 2033
PCT *pending
June 2033
PCT* pending
OXi4503
Composition of Matter: OXi4503 –
salt form
including potassium
October 2021
US 7,078,552
April 2021
EPO 1278758
February 2020
pending
Method of treating myeloid neoplasm by
administering OXi4503
November 2028
November 2028
November 2028
JP 5302328
*A Patent Cooperation Treaty (PCT) application establishes a filing date in all 148 contracting states.
OXiGENE is the owner or exclusive licensee
of more than 120 patents worldwide


32
32
2013
2H13: Ongoing
dialogue with EMA
regarding EU MAA for
ZYBRESTAT
®
in ATC
2H15: Initial data from
potential Ph 2 Taxol
®
and
Votrient
®
+/-
ZYBRESTAT
®
combo trials
2H15: Potential EMA MAA
submission for ZYBRESTAT
®
in ATC
2014
2015
2016
2017
Numerous Upcoming Catalysts
Numerous Upcoming Catalysts
2017: Potential FDA
NDA submission for
Avastin
®
+/-
ZYBRESTAT
®
combo in
ovarian cancer
1H14: Preliminary data from
ongoing Ph 2 Avastin
®
+/-
ZYBRESTAT
®
combo trial (GOG-
186I)
1H14: Potential initiation of Ph
2 Taxol
®
+/-
ZYBRESTAT
®
combo trial
1H14: Potential initiation of Ph
2 Votrient
®
+/-
ZYBRESTAT
®
combo trial
2016 : Potential EU MAA approval for
ZYBRESTAT
®
in ATC
2016: Potential final data from Ph 2
Taxol
®
and Votrient
®
+/-
ZYBRESTAT
®
combo trials
2016: Potential final data from Ph 3
Avastin
®
+/-
ZYBRESTAT
®
combo
trials


33
33
OXiGENE (OXGN) Investment Thesis
OXiGENE (OXGN) Investment Thesis
Compelling Valuation
Currently trading at a market cap of less than $10 million
Leveraging $200+ million previously invested primarily in VDA development
Cost-Efficient and Risk-Mitigated Development Strategy
Ongoing and planned Ph 2 trials supported by foundations, non-profit research
institutions and larger pharmaceutical companies
Significant Potential Value-Creating Events on the Horizon
Enrollment complete for  ongoing Avastin
®
+/-
ZYBRESTAT
®
Ph 2 in ovarian
cancer -
preliminary results expected 1H14
Potential initiation of Taxol
®
+/-
ZYBRESTAT
®
and Votrient
®
+/-
ZYBRESTAT
®
Ph 2 trials in ovarian cancer, as well as a Ph 1a/2b trial in carcinoid syndrome
Completion of enrollment for OXi4503 Ph 1 trial in AML
Actively pursuing development and commercialization agreements with
established industry leaders