Thursday, February 16, 2012

Quotes from the 2/13/12 BIO CEO Conference Presentation by Michael Tardugno

I thought CEO Mr. Tardugno did a very good job presenting an overview of Celsion at the BIO conference earlier this week on Monday. See below for some "quotables" I pulled directly from the presentation:

"We are delighted to have an audience….for a change."

"I want to make one comment. Your company is in the best position it has been since it transitioned to a development company. On the financials and fundamental perspective, the company is strong."

"From the beginning, we thought it was important to position our study with every potential for success."

"The trial is powered at 80% to show a 33% improvement. Interestingly, more than interestingly, one of the things we are quite proud of is this trial has a p value on this data set of .05."

"We’ve conducted ongoing meetings with the agency [FDA]. Every time we call they pick up the phone, every time we’ve asked for a meeting they’ve given us a meeting. I’d like to think that’s because of the quality of our management but I think it is, more importantly, a function of the disease we are studying and this wonderfully innovative approach that we are taking to treat tumors."

"The [HEAT] study has been the center of our life."

"We have asked the DMC to assess risk-benefit on an ongoing basis, as well as a panel of quality metrics. Given our radiologic endpoint, we wanted to make sure our data coming from our investigator sites are consistent with a quality data set that we can file with the FDA…this trial has been monitored frequently and regularly by the DMC and the most recent outcome was, in November, when we announced the successfully pre-planned interim efficacy analysis. What we expected happened, we had a unanimous recommendation from the committee to continue, meaning no evidence of futility or safety problems. What was unexpected is that the DMC indicated to us that we presented them with a model for unblinding at the interim analysis that allows the company to take multiple looks at the data without any significant alpha hit. That’s unusual….on that basis we have submitted a letter to the FDA requesting within the SPA their view and support for a second interim analysis. I get asked all the time when is that going to happen…frankly, we are breaking new ground here as a company, and I think even for the agency. So, we are hopeful to have an answer from the agency in the relative near term. If we do, then I suspect that we could be looking at a 2nd interim efficacy analysis about the middle of the summer. I want to point out that our independent statistician attached the DMC pointed out to the company, after reviewing enrollment rates and event rates, that the company could expect top-line data by the end of the year."

"The drug works, it simply works, there is no doubt about it."

"It’s on that [Phase I data] basis that we are so excited that the Phase III trial has a great chance to be successful. I want to say that to you, a great chance to be successful. When we look into the eyes and listen to the voices of our investigators who we meet with on a regular basis, we know they are interested in seeing data from this trial, and we clearly know they are interested in enrolling patients in this trial."

"If we make some very conservative assumptions, we are talking about capturing about 12.5% of this population, penetrating the market over a 5 year period, with some very conservative pricing assumptions, It’s a billion dollar opportunity. And that’s not just our assumptions. We have had multiple multi-national companies conduct their own due diligence and they have come to the same conclusion."

"Partnering is very important to us. We have had multiple and currently have multiple partners doing diligence. What you can expect from us in terms of a license is something that not only represents value to us, but to our shareholders."

"We have more than 6 quarters worth of cash going forward, more than enough to see us through top-line data from the trial."

Saturday, February 4, 2012

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.