Analyst Conference Summary


conference date: March 27, 2018 @ 8:00 AM Pacific Time
for quarter ending: December 31, 2017 (fourth quarter, Q4)

Forward-looking statements

Overview: Clinical-stage company has two cancer therapies in its pipeline.

Basic data (GAAP):

Q4 numbers were not given, just full year.

Revenue was $ thousand, flat sequentially from $125 thousand and flat from $125 thousand year-earlier.

Net income was negative $ million, down sequentially from negative $5.7 million, but up from negative $ million year-earlier.

EPS was negative $, down sequentially from negative $0.70, but up from negative $ year-earlier.

Ending share count was 7.63 million


Has cash to operate into Q3 2019. Believes will use about $4 million in cash per quarter in 2018.

Conference Highlights:

Michael H. Tardugno, Celsion's CEO, said: "Entering 2018 with more than $25 million in cash , we are well positioned with sound fundamentals, the right resources, and capital sufficient to complete enrollment of our ongoing global, pivotal Phase III OPTIMA Study in primary liver cancer, and continue the trial through the first preplanned, interim efficacy analysis expected in the first half of 2019."

The OPTIMA Phase III study of ThermoDox plus RFA for liver cancer initial readout won't be until Q1 2019. Enrollment was approaching 80% of completion. Should be at full enrollment around Q2 2018. NIH opinion is the chances of success are high, based on analysis of the data from the HEAT study. ThermoDox has both fast track and orphan drug designation. More analysis of the failed HEAT study was released, indicating the OPTIMA study of a sub group could succeed.

In October the Phase III Heat study manuscript was published in Clinical Cancer Research. This included the data analysis and hypothesis on which the OPTIMA study is based. One group of patients from the Heat study continue to show long term, progression free survival.

The NIH is also partly funding an investigator-sponsored Phase 1 study of ThermoDox "in combination with magnetic resonance-guided high intensity focused ultrasound to treat relapsed or refractory solid tumors in children and young adults."

The Dignity study in Europe for Thermodox for breast cancer

GEN-1 Phase 1 OVATION study for newly diagnosed, advanced ovarian cancer final data was announced at the AACR Special Conference. Results were positive with no dose limiting toxicity. Of fourteen treated patients, 2 had a complete response, 10 a partial response, and 2 had stable disease. The highest dose cohort had PFS of over 21 months, compared to historical controls of about 12 months. Opening a 90-patient, randomized Phase 1/2 trial, in Q2 2018, with the change that patients may continue receiving therapy after debulking surgery. The Phase I part of this study will be to allow for a higher dose than in the OVATION study. First data should be available before the end of 2018.

Cash and equivalents ended at $24.1 million, sequentially from $2.7 million. No debt (paid off in June), but had $5.7 million in accounts payable and a $12.5 million milestone liability. In October completed two offerings, raising $23.6 million. Also raised $3.9 million from a Cantor Fitzgerald ATM facility in November. In January raised another $1.3 million from the facility.

Total 2017 operating expense was $19.0 million,consisting of $13.1 million for R&D and $5.9 million for general and administrative expense. Other expense was $1.9 million.

$16.6 million cash was used in operations in 2017.


GEN-1 FDA comments on the protocol? FDA asked us to collect overall survival data in addition to the primary endpoint of PFS (progression free survival).

We all following all the Phase 1 GEN-1 patients for progression and survival, if indeed they do progress.

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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 2018 William P. Meyers