Tuesday, May 15, 2012

"The message today is momentum" — Michael Tardugno, Q1 2012 Conference Call

I highly recommend everyone to listen to today's Q1 conference call, it was particularly detailed and the company sounded rather upbeat (link can be found here). Highlights from today's 2012 Q1 conference call (generally only highlighting what is unique and new):

  • Moving forward with branding and payer research, conducting market research with key stakeholders
  • NDA submission process--Engaged KOLs and moving forward with selection of a CRO with FDA portal access and using a common technical document approach as a basis for NDA and MAA filings.
  • Multimodality approach is the future for a number of cancers, hyperthermia being a key component.
  • On track for 700 patients by the end of Q2
  • Approximately $2M to be paid to Hisun only after technical success (3 registration batches) and after unblinding of data. Registration batches expected to be completed "next year"
  • Yakult remains enthusiastic and that initiation of bridging study will commence after successful HEAT data
  • Ended first quarter with $24.6M dollars, sufficient to fund through Q3 of 2013. 
  • Phase 2 RCW will recruit 40 patients
  • CRLM, RCW, bone mets, and pancreatic cancer trials will "give the oncology a community a snapshot of the broad potential of ThermoDox while it's approval is being considered"
  • Securing multiple manufacturers important for supply continuity. Hisun has recently invested significantly in expanding capacity in China.
  • Next DMC meeting likely in September (DMC meetings are every 3-4 months roughly every 100 patients)
  • Progression and event rates are "substantially following what they consider consistent with a successful trial"
  • Approval for ThermoDox in HCC as early as end of 2013
  • sFDA China regulatory review period could be "cut by half" from 12-15 months, due primarily to the severity and umnet need in HCC. Hisun will support the regulatory process in China. 
  • Target number of patients for HIFU bone mets trial is "in the 20's"
  • No presentations at ASCO or WCIO, first data to be presented will likely be data from RCW Phase 1 trial (my question was in regards to WCIO)
  • Company cannot disclose the average lesion size in the trial (my question)
  • The company would like a business card for "Odaat enterprises" (sorry, had to...that was quite funny...for those who don't know, Odaat is the individual from this blog post)
  • As an FYI, this was the second time I noted both Cowen (Edward Nash) and Cantor Fitzgerald (Mara Goldstein) analysts on the call. 
Let me know if you have any questions or if I missed something. 


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