Bio-Europe Munich 2015 - Telesta Company Presentation

Telesta
Therapeutics
(Toronto Stock Exchange:TST)
Transforming the Bladder Cancer
Treatment Landscape
Focus on MCNA Approval &
Launch
Safe Harbour Statement
This presentation contains forward-looking statements about
Telesta Therapeutics’ business objectives, strategies and outlooks
that involve risks and uncertainties. These statements are “forwardlooking” because they are based on our current expectations about
the markets we operate in and on various estimates and
assumptions. Actual events or results may differ materially from
those anticipated in these forward- looking statements if known or
unknown risks affect our business, or if our estimates or
assumptions turn out to be inaccurate. A detailed description of the
risks that could cause actual events or results to materially differ
from our current expectations can be found in our public filings
available at www.sedar.com. We assume no obligation to update
any forward-looking statement even if new information becomes
available, as a result of future events or for any other reason, unless
required by applicable securities laws and regulations. All amounts
are in Canadian dollars unless indicated otherwise.
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Telesta Therapeutics
•  Focused on MCNA – a biologic therapeutic for 2nd line
treatment of high risk refractory/relapsing non-muscle invasive
bladder cancer
•  Significant unmet medical need
•  Submitted Biologics License Application (BLA) with FDA on
June 30, 2015
•  Designated for Priority Review - August 27, 2015
•  Advisory Committee (AdComm) meeting - November 18, 2015
•  PDUFA date - February 27, 2016
•  Building a targeted U.S. commercial infrastructure
•  Global (ex-U.S., ex-Japan) license with Ipsen on October 28,
2015
•  Seeking Japanese partner
•  Fully funded business plan
Non-Confidential
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Leadership Team
Dr. Michael Berendt
CEO & Chief Scientist
Donald Olds
Chief Operating Officer
Senior Executive Roles: Pharma
(Bayer, Pfizer), Venture Capital
(AEA, RCT) Biotech (Aegera
Therapeutics); Boards: Waters
Corp (NYSE:WAT), Anchor
Therapeutics (Chair), Alethia
Biotherapeutics (Chair), Neomed
Institute
Senior Executive Roles: Biotech
(Aegera Therapeutics), IT, Telecom,
Investment Banking (TD Securities);
Boards: Neomed Institute (Chair),
Oxfam Quebec (Chair)
Brian Ford
Chief Financial Officer
Monique Champagne
Vice President, Clinical
Research
Senior Executive Roles – Finance &
Consulting: Ernst & Young (EY)
Dr. Mathieu Boudreau
Vice President, Corporate
Development & Licensing
Leadership Roles, Corporate/Business
Development – Specialty Pharma &
Biotech: Pendopharm, Pharmascience,
Aegera Therapeutics
Non-Confidential
Leadership Roles: Clinical Research &
Development – Biotech, CROs, Pharma:
Xanthus, Supratek, Quintiles, WyethAyerst, Scat
Brian Groch
Chief Commercial Officer
Leadership Roles: Commercial
Operations, Market Access, Marketing
& Sales – Specialty Pharma/ Pharma:
Horizon Pharma, Exsto, Dendreon,
Novartis, Merck & Co.
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Strategic Transformation
New
Management
Team
Divested
Non-Core
Legacy
Assets/
Focus on
MCNA
BLA Filed Priority
Review with
Feb. 27th,
2016
PDUFA
Date
US
Healthcare
Institutional
Investor-led
Private
Placement US$28.6
million
Strategic
Priorities:
•  MCNA Approval
•  U.S. Commercial
Launch
•  ROW license ✔
Focus on Execution, Human Therapeutics, Value Creation
Non-Confidential
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MCNA • 
• 
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• 
Non-Confidential
About Bladder Cancer
MCNA Characteristics & Clinical Efficacy
FDA Dialogue/Current Regulatory Environment
Commercial Opportunity
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Bladder Cancer Statistics •  74,000 new annual cases in U.S. (16,000 deaths)
•  4th most common cancer in men
•  3.8:1 men/women ratio
•  70-80% diagnosed at the non-muscle invasive stage
•  Highest lifetime treatment cost per patient at $230,000
•  Cost of major surgical intervention
•  Cost of post-surgical maintenance
•  No new therapeutic option since 1998 (US only)
Non-Confidential
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Bladder Cancer Staging
Non-Muscle Invasive
Bladder Cancer (NMIBC)
CIS: Carcinoma in situ
Ta, T1: papillary tumors
Non-Confidential
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NMIBC Treatment Guidelines
•  Standard of care 1st line therapy for high-risk NMIBC is
intravesical BCG treatment
•  When patients fail to respond to 1st line therapy, U.S.
treatment guidelines call for a radical cystectomy
(surgical removal of the bladder and adjacent organs)
•  Papillary tumor patients (Ta/T1) and CIS patients eligible
for cystectomy have no approved treatment options
Telesta is seeking approval for MCNA as 2nd
line therapy as an alternative to cystectomy
Non-Confidential
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MCNA • 
• 
• 
• 
Non-Confidential
About Bladder Cancer
MCNA Characteristics & Clinical Efficacy
FDA Dialogue/Current Regulatory Environment
Commercial Opportunity
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MCNA – Drug Characteristics
•  MCNA was discovered by Telesta and is
manufactured at its facility in Montreal, Quebec
•  MCNA is a biologic therapeutic prepared from the
fractionation of a pure culture of Mycobacterium phlei,
a non-pathogenic bacteria
•  It is prepared as a suspension in sterile water and
delivered, like BCG, intravesically, directly into the
bladder; no special handling procedures are required
•  MCNA’s efficacy is believed to be the result of immune
stimulation and direct anti-cancer effects
Non-Confidential
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MCNA – Phase 3 Study Overview
•  Design: Open-label, single-arm trial
•  Primary endpoint: 40% Disease Free Survival (DFS) at 1 year
•  Objective:
evaluate the efficacy and safety of MCNA in
patients with NMIBC at high risk of recurrence and
progression who had failed intravesical BCG therapy
•  Patients Treated:
129 patients with high grade papillary
(Ta, T1) and/or carcinoma in situ (CIS)
•  Enrollment: 25 centers across the U.S. and Canada
Telesta is seeking FDA Approval based on a single Phase 3
trial that did not meet its primary endpoint
Non-Confidential
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MCNA – Phase 3 Summary Results
Clinically relevant
primary endpoint
•  25% overall Year 1 DFS rate
•  35% Year 1 DFS rate in patients with
papillary tumors only
Additional clinical
benefits
•  Long duration of response – median
duration of 33 months
•  Reduced rate of cystectomies
•  Reduced risk of progression
Excellent safety and
tolerability profile
•  Relatively few and mild adverse events
•  No special handling or disposal required
Phase 3 pivotal study data and post-hoc analyses published in
The Journal of Urology
Non-Confidential
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MCNA – Clinical Results Published in The Journal of Urology
Non-Confidential
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MCNA • 
• 
• 
• 
Non-Confidential
About Bladder Cancer
MCNA Characteristics & Clinical Efficacy
FDA Dialogue
Commercial Opportunity
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Significant FDA Dialogue • 
• 
• 
• 
• 
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February, 2014: Initiated dialogue with US FDA
February – July, 2014: Active dialogue
July, 2014: FDA issues letter permitting a BLA filing
November, 2014: Pre-BLA meeting held in Washington
February, 2015: Type C facility meeting held with FDA and Telesta
June 29, 2015: Telesta submits BLA to US FDA
August 28, 2015: FDA accepts BLA for filing, grants priority review
November 18, 2015 – FDA Advisory Committee meeting
February 27, 2016 – PDUFA date
Non-Confidential
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MCNA • 
• 
• 
• 
Non-Confidential
About Bladder Cancer
MCNA Characteristics & Clinical Efficacy
FDA Dialogue
Commercial Opportunity
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Current Competitive Environment •  No new agent for BCG refractory/relapsing non-muscle
invasive bladder cancer since 1998 (Valstar – US only)
•  Limited late-stage competition
•  Significant global BCG shortage
•  FDA/AUA Bladder Cancer Workshop (May 2013)
•  Confirmation that single-arm trial design appropriate
for BCG failure patients (no suitable comparable)
Non-Confidential
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Significant Commercial Opportunity
•  Large unmet medical need for a therapeutic alternative to surgery
•  Same situation in almost every region of the world
•  Strong medical education opportunity based on unmet medical need/
limited current alternatives
•  Small targeted sales force required
•  MCNA fits with current practice – not trying to change the paradigm
•  MCNA is easy to use/handle
•  No special handling/disposal requirements
•  Controlled ambient temperature supply chain/distribution
•  Expectation of few reimbursement issues – alternative to risky and
expensive surgery
•  Strong IP position – 2031 in most regions of the world
Confidential
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U.S. Market Assessment
•  Medical Marketing Economics (MME) conducted a
comprehensive 3rd party US market assessment
•  Conclusions:
•  Target product profile of MCNA very well received by
urologists
•  No US reimbursement issues anticipated
•  Potential for premium oncology pricing
•  US peak market estimate >US$400 million
•  Telesta assumes similar ROW opportunity
Non-Confidential
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MCNA Partners
•  United States:
•  ROW (ex Japan)
•  Canada, Mexico & South Africa
•  South Korea
•  Japan
Non-Confidential
TBD
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MCNA – Opportunity Summary
Unmet medical
need driving
regulatory changes
•  Lack of therapeutic alternative to radical
cystectomy after 1st line failure
•  BCG shortage
•  FDA/AUA dialogue leading to favorable
regulatory changes
Transparent
dialogue with FDA
•  Open and active dialogue/interaction with
FDA over last 12 months
•  Supportive regulatory climate
•  AdComm set for November 18th
•  PDUFA Date – Feb/2016
Specialty Pharma
Profile
•  Near term revenue opportunity
•  Small & efficient sales infrastructure
•  Strong competitive position
•  High margins
•  IP protection to at least 2031
Non-Confidential
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Thank You/Merci/Danke!
For questions or investing or partnering interest please contact:
Donald Olds,
Chief Operating Officer
[email protected]
www.telestatherapeutics.com
Non-Confidential
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