Transcript MASS Opportunities

Corporate Presentation
July 17, 2015
Safe Harbor Statement
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,” “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
technology and its efficacy at acceptable dosage levels, the ability to raise capital when
needed and on reasonable terms, successful clinical trial results, developing the necessary
manufacturing processes and gaining all necessary regulatory approvals. 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 reports to the Securities
and Exchange Commission including our 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.
Corporate Overview
• World Leader in Vascular Targeting Technology
• Lead Vascular Targeting Agent (VTA): CA4P
– Exclusive Worldwide Retained Rights
• Primary Therapeutic Focus: Oncology & Ophthalmology
• Headquarters: Watertown, MA
• Employees: 10 on staff
– All R&D activities outsourced
• Traded on NASDAQ and Stockholm exchanges
• Cash on Hand (03/2003): $10.0 million
• Annual Burn Rate: $6 million
Recent Pipeline Developments
CA4P has lead position in VTA clinical development ahead of compounds
from AstraZeneca and Aventis:
• 10/2001: Completed three Phase I clinical trials of CA4P in ~100 patients
• 06/2002: Initiated Phase Ib combination trial of CA4P with Carboplatin
targeted at various solid tumors
• 10/2002: CA4P approved for funding by the Foundation Fighting
Blindness (FFB), a leading U.S. eye charity, for a Phase I/II trial in
age related macular degeneration
• 12/2002: Initiated Phase II single agent trial of CA4P targeted at anaplastic
thyroid cancer
• 01/2003: Initiated Phase I/II combination trial of CA4P with radiotherapy
targeted at head & neck, prostate and lung cancers
• 03/2003: OXiGENE’s first owned VTA patent issued
• 05/2003: OXi8007 discovery announced
Organization
Business Model – Virtual Company
In License
from
Universities
Pre-clinical
Out License
to
Big Pharma
OXiGENE
Phase I
Phase II
Phase III
Marketing
• University Collaborations Include: Arizona State University, The University
of Lund, Baylor University and The University of Florida
Product Pipeline
Product Candidates
Vascular Targeting
Combretastatin A4P
Single Agent Safety
Combination w/Carboplatin
Combination w/ Radiotherapy
Single Agent Anaplastic
Thyroid Cancer
Ocular disease – FFB
2nd Generation VTA
Oxi-6197 (NCI)
Oxi-4503
Oxi-8007
Pre-Clinical
Phase I
Phase Ib
Phase I/II
Phase II
Occlusion of Microvessel
Advantages of Vascular Targeting
• Damage to an exiting single vessel can kill
thousands of tumor cells
• Do not need to kill all endothelial cells
• Endothelial cells are adjacent to blood stream,
therefore overcoming delivery problems
• Endothelial cells are non-malignant, so mutants
unlikely to emerge
Occlusion of Microvessel
Vascular Cast Model
Photomicrograph on the left shows a vascular cast of an untreated tumor highlighting the
high density of tumor vessels in the center and at the host – tumor interface. The one on the
right shows a vascular cast of a tumor one hour after treatment with CA4P, showing a
marked reduction in tumor vasculature, especially at the interface. (Magnification X40)
Phase I MRI Parameter Images
Pre-treatment
24 Hrs Post-treatment
Ktrans
Pelvic leiomyosarcoma, 52 mg/m2, #31
Dynamic Contrast Enhanced - Magnetic Resonance Imaging (DCE-MRI) using
the paramagnetic contrast agent gadopentetate dimeglumine (Gd-DTPA)
CA4P Phase I Results
•
2 U.S. trials, 1 U.K. trial
•
Patients had failed chemotherapy
•
Total of approximately +90 patients dosed as monotherapy
•
CA4P well tolerated, manageable and reversible side effects
•
Blood flow reduction
•
Promising clinical effects
•
Total of 14 clinical ‘effects’
1 Complete Response
1 Partial Response
2 Measurable reductions in tumor size
10 Stable Disease
Activity Data by Tumor Type
Regimen
(mg/m2)
Tumor
Response
Time Period
A. Thyroid
Complete
Response
3 years,
1 month
60 q 21 d
M. Thyroid
Stable Disease
1 year,
9 months
60 q 21 d x 1 cycle
Fibrosarcoma
Partial
Response
7 months
75 q x 5
Pancreatic
20% reduction
in tumor size
2 months
90 q 21 d
Pancreatic
20% reduction
in tumor size
7 months
75 q x 5
Colon
Stable Disease
1 year,
5 months
60 q 21 d
Phase Ib trial
Dose escalating Phase Ib in combination with Carboplatin
commenced June 2002
-
University of Pennsylvania Cancer Center
Lead Investigator: Dr. Peter O’Dwyer
Expected to enroll 35 patients
4 patient cohorts at 30/5, 40/5, 50/5, 50/6
Multiple types of solid tumors
Initiated 2 out of 4 cohorts
No drug related SAEs reported
Combretastatin A4-Prodrug
Clinical Development Plan
• Phase II mono in ATC at Case Western
• Phase I/II combination radio. MV Hosp.
• Other combination trials targeted at specific
cancer types
Other NCE’s in Development
• Oxi 4503 to enter the clinic in 2004 with leading cancer
institution
• Oxi 6197 in pre-clinical studies with NCI
• Oxi 8007 evaluation in in vivo testing
Competitive Advantage of VTAs in Development
Company
Drug
Stage
CA4P
Three Phase I Complete
Phase Ib w/ Carboplatin
Phase II Single agent
Phase I/II w/radiotherapy
Oxi-4503
Pre-Clinical
AstraZeneca
ZD6126
Phase I
Aventis
AVE8062
Phase I
OXiGENE
VTA Non-cancer Indications
• Ocular
- Diabetic Retinopathy
- Macular Degeneration
- Phase I/II trial in ARMD with
Foundation Fighting Blindness
CA4P Treatment Inhibits Corneal Neovascularization
CA4P (IV) Treatmenta
No Treatment
LHP
LHP
2 mm
a50
mg/kg CA4P IV [qdx5] x 2
Finances at March 31, 2003
•
•
•
•
Cash
$10.0 Million
Annual Burn Rate
$ 6 Million
No Debt
Straightforward capital structure
Management Team
Frederick Driscoll
President and Chief Executive Officer
David Chaplin, Ph.D.
Chief Scientific Officer and Head of Research and
Development
Scott Young
Vice President Clinical and Regulatory Affairs
Clinical and Scientific Advisors
Håkan Mellstedt, M.D.,Ph.D.
Professor Karolinska Institute
Chairman CTAB
Hans Wigzell, M.D.,Ph.D.
Professor Karolinska
Chairman SAB
Margaret A. Tempero, M.D.
President Elect ASCO
UCSF Cancer Ctr.
Lee Rosen, M.D.
Director
UCLA Cancer Program
Jan B. Vermorken, M.D., Ph.D.
Prof. of Oncology & Dept. Head
Univ. Hosp. of Univ. of Antwerp
Robert S. Kerbel, Ph.D.
Professor of Oncology
University of Toronto
Dietmar W. Siemann, Ph.D.
Prof. Of Oncology Univ. of Florida
College of Medicine in Gainesville
Marvin H. Caruthers, Ph.D.
Prof. of Chemistry/Biochemistry
University of Colorado
Investment Highlights
• CA4P in leadership position in clinical trials Phase II
• Most promising Phase I data of any VTA in clinic
• Strong patent coverage
• Straightforward synthesis process, low cost of goods
• Oxi4503 accepted by prestigious cancer institution for
clinical development
• Oxi6197 accepted by NCI for development
• Leverage CA4P for ocular and oncology licensing
• Experienced management and advisory teams