Analyst Conference Summary


conference date: November 14, 2017 @ 8:00 AM Pacific Time
for quarter ending: September 30, 2017 (third quarter, Q3)

Forward-looking statements

Overview: Clinical-stage company has two cancer therapies in its pipeline. But low on cash and raised $28.6 million in Q3 and October by selling shares and warrants.

Basic data (GAAP):

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

Net income was negative $5.7 million, down sequentially from negative $4.9 million, but up from negative $6.4 million year-earlier.

EPS was negative $0.70, down sequentially from negative $0.79, but up from negative $3.22 year-earlier.

Ending share count was 8.06 million, up from 2.0 million year-earlier.


Has cash through the end of Q2 2019; first data from Phase 3 trial data could be in Q1 2019. Expects cash used in operations to be around $4 million per quarter.

Conference Highlights:

Michael H. Tardugno, Celsion's CEO, said: "We believe that we now have sufficient capital to complete enrollment of our Phase III OPTIMA Study and through the first efficacy analysis expected in the first quarter of 2019. Further, we expect that our current funds will allow us to make substantial progress in our open label, randomized, 86 patient Phase I/II study of GEN-1 in newly diagnosed stage III and IV ovarian cancer patients."

The OPTIMA Phase III study of ThermoDox plus RFA for liver cancer initial readout won't be until Q1 2019. In September enrollment was approaching 70% of completion. Should be at full enrollment around Q2 2018. NIH opinion is the chances of success are high. ThermoDox has both fast track and orphan drug designation.

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.

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."

An NIH-supported preclinical study supported the possible use of ThermoDox for bladder cancer.

The Dignity study in Europe for Thermodox for breast cancer is ready to start except for financing.

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. Celsion expects to open a Phase 1/2 trial before the end of 2017, 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.

Cash and equivalents ended at $2.7 million, sequentially from $3.6 million. No debt (paid off in June), but had $5.5 million in accounts payable. Cash used in operations was $5.1 million. During the quarter raised $5.0 million in a stock and warrant offering. In October completed two offerings, raising $23.6 million.

Total operating expense was $4.5 million,consisting of $3.3 million for R&D and $1.2 million for general and administrative expense. Other expense was $1.3 million.


Relatively healthy immune systems for next GEN-1 study? These are typically treatment naive. If they had prior chemotherapy, that would alter their immune status.

OVATION study 75 mg patients, any died? They were the last enrolled. They had surgery, and have not progressed. None of the patients on the study have died.

Current share count? About 16 million. Warrants are in the money at $3 to above $6, about 3 million. So under 19 million on a fully diluted basis. No current plans for future dilution, but could be opportunistic. We will also look for non-dilutive means to enhance cash.

Exelixis product for liver cancer, what is the difference? It is a kinase inhibitor for advanced HCC. We are looking at newly diagnosed HCC patients. We know of no drugs in our indication for Phase 3. RFA is becoming a standard alternative to surgery, ThermoDox would be an addition to RFA. We believe there will be no competition "for a very, very long time."

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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