Analyst Conference Summary


conference date: March 16, 2017 @ 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. But low on cash despite a small raise in the quarter.

Basic data (GAAP):

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

Net income was negative $ million, down sequentially from negative $6.4 million, and down from negative $ million year-earlier.

EPS was negative $, down sequentially from negative $0.23, and down from negative $ year-earlier.



Conference Highlights:

"Celsion had an exceedingly productive 2016 as our accomplishments, one after another, established meaningful progress with respect to our two leading-edge technology platforms designed to enhance clinically powerful therapies. With sound fundamentals, the superb execution of our ongoing global, pivotal Phase III OPTIMA Study in primary liver cancer, continues to attract interest and support from the medical community, international regulatory agencies, and research organizations like the National Institutes of Health for this ground-breaking study," said Michael H. Tardugno, Celsion's CEO. "Operating fundamentals of the company are sound."

Spending has been reduced to $1.4 million per month. Therapies address billion dollar markets.

The shareholder meeting will be important, including a vote to reverse split the stock and to raise $25 million by issuing 20% more shares. Both could get Celsion to a more positive financing environment

The OPTIMA Phase III study of ThermoDox plus RFA for liver cancer readout won't be until 2H 2018 [previously had said Q1 2018]. NIH opinion is the chances of success are high. Highly supportive data from the Phase III heat study was presented in August, for a subset (the trial failed to reach its endpoints as a whole.) The Chinese regulators have indicated they could approve the therapy, pending positive data, without prior approval by the FDA or EMA. Vietnam will add 5 trial sites.

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."

GEN-1 Phase 1 OVATION Study for newly diagnosed, advanced ovarian cancer data to be revealed at ASCO in June. Data from first 12 patients presented in January showed 100% disease control and 75% complete response including 1 pathologic complete response. Early stage drug combination studies also showed strong results.

Cash and equivalents ended at $4.5 million, down sequentially from $8.7 million. In December raised $1.8 million from a stock offering. In February raised an addition $5 million.

Did not give Q4 expense data, gave 2016 data instead. Q4 should be in 10-Q. Operating expenses of $ million consisted of $ million for R&D and $ million for G&A. Loss from valuation of common stock warrant liability was $ million, interest expense was $ million.

$18.4 million cash was used in operations for the full year 2016. Full year net loss was $22.1 million or $0.85 per share.


Optima enrollment? Approaching 50%. About 40 patients enrolled in China, but that is picking up quickly. It took a long time to get CFDA approval to open sites there. We need 200 patients in China.

2017 operating expenses? $1.3 to $1.4 million per month.

Regulatory filing in China, level of efficacy required? CFDA has done a marvelous job bringing their approval standards up, consistent with EMA and FDA. Objective is a 33% improvement in overall survival over the control arm. That would be over a year in additional survival. Must also be powered to show statistical significance.

Children's Research Institute Phase 1 trial? Things are up and ready to go. They are recruiting patients.

NIH analysis acceptance by peers? "The medical community gets it." Doxorubicin is well recognized, activating with heat can be effective in difficult situations. Researchers talk about ThermoDox being potentially curative. We have had a few skeptics in review boards, mostly surgeons who want to cut the cancers out. In Germany the NIH analysis has had a very positive impact.

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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 2017 William P. Meyers