Analyst Conference Summary


conference date: August 15, 2016 @ 8:00 PM Pacific Time
for quarter ending: June 30, 2016 (second quarter 2016)

Forward-looking statements

Overview: Released final analysis from the earlier ThermoDox trial showing there is a subset of patients in it that can be identified and treated with high likelihood of success to be confirmed in the current Phase 3 trial. Low on cash, but not spending much either.

Basic data (GAAP):

Revenue was $125 thousand.

Net income was negative $4.5 million.

EPS was negative $0.19.


Expects to use $4 million in cash for operations per quarter in the remainder of the year.

Conference Highlights:

In June Celsion raised $6 million in cash in a direct stock offering and warrants may provide an additional $6 million in cash within 6 months.

The final analysis of the Phase 2 trial of ThermoDox plus RFA (radio frequency ablation) showed very positive results in a well-defined subset of liver cancer patients.

The OPTIMA Phase III study of ThermoDox plus RFA for liver cancer is being expanded with sufficient patients in China to allow for regulatory approval there if the results are positive. About half the world's new cases of liver cancer occur in China. It is currently over one-third enrolled. Went to some length to refute naysayers about the possibility of success. Sounded believable to me. But the readout won't be until 2018.

Positive data was reported from the Phase 1b dose escalation study (OVATION) of GEN-1 for newly diagnosed, advanced ovarian cancer. "with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. The efficacy data included encouraging tumor response rates, successful surgical resections of the eligible patients' tumors, impressive pathological responses and dramatic drops in CA-125 protein levels. Enrollment in the third cohort is completed. Celsion expects the 4th, and final, Phase 1 cohort of the OVATION Study to be fully enrolled this year." A manufacturing and supply agreement for GEN-1 was made with Hisun Pharmaceutical. In discussions with FDA to expand the study into a Phase 2 study. Has been contacted by "a few big pharma companies" about the results.

Cash and equivalents ended at $14.4 million.

Operating expenses of $4.9 million consisted of $3.3 million for R&D and $1.5 million for G&A. Gain from valuation of common stock warrant liability was $0.4 million, interest expense was $0.2 million.


Optima enrollment? Over one-third. Adding sites. Looking at adding 4 sites in Vietnam. On track. Expect 50% enrollment by end of 2016. Complete enrollment goal is 2017.

GEN-1 third cohort data? Three patients are being treated, takes about 10 weeks. Could report data in October. Translational data from first six patients could be available at about the same time. Fourth cohort data could be in March, which could include translational data for all the patients.

Going forward with GEN-1, the plan would depend on our discussions with the FDA.

Early access ThermoDox? We have seen interest from investigators, we are exploring options including pricing.

HEAT (Phase 2) study Chinese cohort survival benefit? We have over 200 patients in the Chinese cohort. It is consistent with the overall cohort.

Possibility of collaboration on GEN-1? We have seen interest, also for ThermoDox. There are ongoing discussions. We still have something to prove with ThermoDox, that it is not just a subgroup thesis. With GEN-1 we are early in the development cycle. More data might increase interest in the drugs. We also saw interest in TheraSilence, based on the preclinical data.

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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my blog and Seeking Alpha articles.

Copyright 2016 William P. Meyers