Celsion 2012 Anticipated Milestones and Events

While it is hard to predict with any measure of confidence, below are my own estimates of potential company news releases from Celsion, and approximately when we can expect them in 2012. Note that many of these are "carryovers" from milestones that were expected to happen in 2011. The timing attached to each of these is simply a guess from my end, so do take it with a grain of salt. The wild card I see here is, of course, the Phase III HEAT SPA amendment process, as well as the timing for a potential 2nd licensing deal. At the rate things have been going from a business development perspective in the biotech world to kick off 2012, a 2nd license agreement could come any day it seems. That said, I think it will follow closely in the timeframe of the potential 2nd interim analysis.

When I spoke to CEO Michael Tardugno just before the Christmas break, he made it very clear that the company is squarely focused on the tasks ahead of them. As is evident from this list, there are a lot of things on the company's plate. 

• Q1 2012 
• Manufacturing of 3 registrational batches of ThermoDox complete 
• Treatment of 1st (of approx. ~90 planned total) patient in ABLATE randomized Phase II CRLM study 
• Announcement that HEAT enrollment of 200 patients in China has been completed 
• Go-forward decision for RCW Phase I/II protocol 
• Update on potential SPA amendment process for Phase III HEAT study 
• Update on Philips IND process for ThermoDox + HIFU in bone metastases
• Key meetings: BIO CEO Conference Presentation (2/13), FY 2011 company call (mid-March) 

• Q2 2012 
• Realization of sufficient PFS events (275-300 in my opinion) for potential 2nd interim analysis in HEAT study 
• Results from potential 2nd interim analysis 
• Update from Yakult-Honsha regarding new study of ThermoDox in HCC in Japan (Note: Newly added after original post, how could I forget about this one?)
• Initiation of newly expanded RCW trial (Phase I/II TBD, likely not registrational anymore) 
• Rolling NDA initiation for ThermoDox in HCC
• Update on carboplatin preclinical work 
• Update on mystery “product #4”, and potential partner behind this initiative 
• Publication/presentation of RCW Phase I data at a selected medical conference
• Potential 2nd licensing deal announced for all ex-US geographies, or for select ex-US regions 
• Key meetings: Q1 2012 company call, Annual Shareholders Meeting, ASCO, WCIO 

• Q3 2012 
• Initiation of Philips/Celsion Phase II bone metastases study (although, again, I have seen some reports putting this at Q4 of 2012, no update on the company regarding this discrepancy yet) 
• Unfortunately, if no 2nd license deal, potential share offering at this point (Note: Upon second thought, moved this to Q3 from Q2)
• Key meetings: Q2 2012 company call

• Q4 2012 
• If trial successfully stopped at 2nd interim analysis, NDA submission complete by this time 
• If trial did not stop at 2nd interim, or no SPA amendment granted at all, realization of 380 PFS events in HEAT study
• Key meetings: Q3 2012 company call

I know a lot of savvy investors visit my blog, so if I missed anything, please let me know and I will update this list accordingly. 

Best,

Siavoche