- The general tone of all speakers was quite positive, in my opinion. This is somewhat touchy feely and subjective I understand, but my 'spidey sense' is usually quick to pick up on optimism in one's tone of voice :-)
- Initiation of the interim analysis for the HEAT trial will take place once 190 events are confirmed by the company's independent radiology CRO, and data collection will take a "minimum" of 8 weeks. It sounds as if the company is awaiting a new update of the total number of PFS events confirmed to date. Looking at the 10-Q this morning, it appears management has slightly shifted the timeline for the interim analysis data from September to "Q4", although my guess is that it would be no later than end of October.
- Assuming the HEAT trial is not stopped at the interim, the CEO said the top-line readout of 380 events could happen "possibly as early as 1 year from now."
- Dr. Borys, the chief medical officer, clearly stated that the DMC's interim analysis will take into account safety, efficacy and overall risk-benefit profile. He was clear in reminding investors that it would be "inappropriate to give a singular number or statistical criteria that would be indicative of a positive outcome."
- In China, 150 patients have been enrolled to date, and the study will continue enrolling patients until registrational target of 200 is reached. South Korea and Taiwan have already hit their enrollment requirements. Of note, Dr. Borys mentioned that Yakult, Celsion's Japanese partner, will enroll patients in a separate study from the HEAT study to support a registrational filing.
- No official decision on the RCW DIGNITY Phase II study yet in terms of expanding the trial to include other cancers. Of note, if the trial is expanded into other cancers (either superficial cancers or earlier line RCW), it will remain a Phase II but will not be registrational because it will likely be randomized and include a control arm (asked by yours truly).
- Celsion had a meeting with the EMA pre-advice committee. They will resubmit their briefing book submission later in August, and are expecting guidance for their EU filing strategy from the EMA by year end.
- The company announced that they are initiating the colorectal liver mets study, which will be led by Dr. Steve Libutti. The company plans to have 6-8 total sites, and the company reiterated their goal of having liver mets data on hand by the time of Thermodox' approval in HCC.
- Michael Tardugno reiterated in the Q&A that all company revenue forecasts made to date for Thermodox in HCC assume that 25% of patients are eligible for RFA, and Celsion peak share will be half of that, or 12.5%. They are assuming time to peak share will be 5-7 years following launch.
- (UPDATE: Forgot to include pricing discussed during Q&A) In discussing potential pricing of Thermodox, the CEO mentioned that Doxil and Nexavar are being explored as potential analogs, priced at $12K and $60K per course of therapy, respectively. The company will likely partner with vendors and other consultants to conduct a global pricing study to inform future pricing decisions. My suspicion is that they will not price Thermodox more than $10K-$20K maximum per treatment in HCC (recall that dosing in other indications, such as RCW, will be much greater than liver, and thus, total cost for a course of therapy will be much higher)
- Raised $33.6M since beginning of the quarter, $25M of which was in Q3.
- Company has enough cash to last until Q4 2012
- No plans to tap CEFF in the future
- All preferred stock will be converted to common by end of August
- 36 million shares fully diluted