Analyst Conference Summary


conference date: November 15, 2018 @ 8:00 AM Pacific Time
for quarter ending: September 30, 2018 (third quarter, Q3)

Forward-looking statements

Overview: ThermoDox Phase 3 trial completed enrollment, with 2 interim data readouts expected in 2019.

Basic data (GAAP):

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

Net income was negative $4.7 million, up sequentially from negative $8.2 million, and up from negative $5.7 million year-earlier.

EPS was negative $0.26, up sequentially from negative $0.46, and up from negative $0.70 year-earlier.


Has cash to last to 2019 data points. Expects cash burn to decrease.

Conference Highlights:

Michael H. Tardugno, Celsion's CEO, said: "During the last quarter Celsion made excellent progress with our clinical development programs, including completion of enrollment in our 550-patient global, pivotal Phase III OPTIMA Study of ThermoDox in primary liver cancer in August 2018, as expected, and initiation of patient enrollment in our 130-patient follow-on Phase I/II randomized OVATION 2 Study of GEN-1 in patients newly diagnosed with ovarian cancer. In October 2018, we took steps to eliminate the warrant overhang created from our earlier financings in 2016 and 2017 resulting in a clean capitalization structure." Depending o on the event rate, cash may be sufficient to operate until the final results of the Optima study.

The OPTIMA Phase III study of ThermoDox plus RFA for liver cancer completed enrollment in August 2018. Initial interim readout should be in late Q2 2019, but has a relatively high bar for success. A second interim readout is also planned, with a lower bar, later in 2019, then a final readout in 2020 with the lowest bar for success and submitting an NDA. Enrollment should complete in 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. Analysis of the failed HEAT study indicates the OPTIMA study of a sub group could succeed.

Plans to sell Net Operating Losses (NOLs) to the State of New Jersey for about $10 million in cash, before the end of 2018. May seek additional NOL sales in 2019.

In July a new Phase 1 ThermoDox study was published in The Lancet Oncology with PFS of 20.8 months, supporting the hypothesis for a successful Phase 3 outcome.

In October 2018, Celsion announced final clinical results from the dose escalating Phase IB OVATION I trial of neoadjuvant chemotherapy (NAC) and GEN-1 in newly diagnosed patients with Stage III/IV ovarian cancer. Median PFS in patients treated per protocol (n=13) was 24.3 months and was 17.1 months for the intent-to-treat population (n=18) for all dose cohorts. OVATION 2 dosed its first patient. The Phase I part of this study will allow for a higher dose than in the OVATION study. Will have 130 patients total. First data should be available towards the end of 2018. Phase 2 could start in Q2 2019. In October 2018, an overview of GEN-1 was published in the peer-reviewed journal Future Oncology.

Celsion was added to the Russell Microcap index in June.

Earlier in 2018 met with China FDA, which confirmed that an NDA in China can be filed using survival rates, which should be a lower threshold for success than OS (overall survival).

Cash and equivalents ended at $22.0 million, down sequentially from $26.1 million. Cash includes $10 million from the June 2018 venture debt facility. Did not state total debt.

In October 2018 a warrant exchange agreement was made to issue 820,714 new shares of company stock in exchange for the 2017 warrants, at 0.5 shares for each of 1.64 million warrants. At November 14 Celsion had 18.7 million shares and 1.6 million warrants outstanding. 1.2 million outstanding warrants will expire in April 2019 as they have exercise prices over $6.00 per share.

Total operating expense was $4.1 million,consisting of $2.2 million for R&D and $2.0 million for general and administrative expense. Gain from valuation of warrant liability was $4.1 million; loss from impairment of in-process R&D $4.5 million; interest and other expense net $0.2 million.

Still has $11 million available in ATM from Cantor Fitzgerald.


Optima PFS curve update at interim? With DMC compared latest data to the prior subgroup data, which we should see again at the interim analyses. The timing of the interim analysis is dependent on the number of patient deaths. We may need to update the timing based on events.

GEN-1 new study design, need for first 12 patients? Phase 1 is to see if we can raise the dose without toxicity, given that there may be a dose related response. We could conceivably complete the dosing portion with only 6 patients, but decided to randomize 12 patients so the data can be part of the overall data set for the primary endpoint. So far we have a PFS median of over 17 months, compared to the usual 12 months. With a total of 130 patients the data should be very solid.

If approved, how will you commercialize ThermoDox? We will do what is best for shareholders. We expect to partner with a major pharma company for sales outside the U.S. China would be a big, perhaps the biggest market. We could bring it to market ourselves in the U.S., we would need capital, but would consider licensing.

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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