TELESTA THERAPEUTICS INC T.TST

AGM presentation - Online

[simouuun]

https://telestatherapeutics.com/cms/phpuYvle9.pdf

2016 Value Drivers

•Advisory Committee Recommendation
•Successful site audit
•US Approval
•US Launch
•Japanese License
•Regional progress via our partners
•U.S. listing

AdCom Preparation/Status
• Working with consultant ECG
• 2 mock panels conducted to date
• Ex FDA personnel and KOL’s engaged
• Numerous teleconferences
• KOL’s engaged
• Patient advocates identified
• FDA questions and list of panel members to
be received November 16

Japanese Partnering Strategy
Context:
• Registration of MCNA in Japan will require further development in
Japan (potentially P1 safety and even P3)
• Market opportunity in Japan potentially more limited in view of
Urologists being aggressive about cystectomy. Reference pricing in
Japan is more of an issue as the reference product may be BCG
which is priced very low
• Japanese companies are very risk averse and will tend to wait for US
approval before recommending and executing a deal
Strategy:
• Leverage Ipsen deal as a validation of MCNA and Telesta value
• Continue to foster discussions (Bio-Europe, TC’s, etc..)
• Capitalize on positive AdComm to accelerate diligence and
discussions

[onlytruthhere]

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[Tson99]

Interesting..... On page 16 they talk about VMC feasibility analysis to be initiated post AdCom.

[13PunterDog]

I personally like page #9 , " Adcom Prep/ Status". Sounds like they have their sh!t together. No surprise with this management team. Go team! Cheers 13PD

[txbioinv]

thanks sim