Analyst Conference Summary


conference date: May 10, 2018 @ 8:00 AM Pacific Time
for quarter ending: March 31, 2018 (first quarter, Q1)

Forward-looking statements

Overview: Clinical-stage company has two cancer therapies in its pipeline. Stock is undervalued because the most advanced trial is based on a subgroup analysis, which is typically risky. But this looks well thought out and highly likely to succeed, which would make this a 10x or more gain for investors if the ThermoDox trial results are positive.

Basic data (GAAP):

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

Net income was negative $4.5 million, up sequentially from negative $5.7 million, and up from negative $5.2 million year-earlier.

EPS was negative $0.25, up sequentially from negative $0.70, but up from negative $3.09 year-earlier. [but not year-earlier had far fewer shares, just 1.7 million]

Ending diluted share count was 17.68 million, up about 10 million shares sequentially.


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: "we are well positioned to complete enrollment in our ongoing 550 patient global, pivotal Phase III OPTIMA Study in primary liver cancer and to initiate our 130 patient Phase I/II randomized OVATION II Study in newly diagnosed patients with ovarian cancer in June 2018 and reporting clinical findings from the Phase I cohort of 12 patients of the OVATION II by the end of 2018. Our GEN-1 immunotherapy has generated impressive results to-date. We expect to report final progression-free survival data from our Phase IB clinical trial (the OVATION I Study) by the end of the second quarter of 2018. "

The OPTIMA Phase III study of ThermoDox plus RFA for liver cancer initial readout won't be until Q1 2019. Enrollment is over 85% of complete. Should be at full enrollment around June 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.

The Data Monitoring Committee recommended continuing the study in April, based on analysis of 75% of patients to be enrolled. Analysis of blinded data put PFS at 20.8 months, in line with the intent-to-treat group subgroup analysis.

In April ThermoDox's potential was discusssed at a presentation at the International Liver Congress. Another presentation was made in February at the Korea Liver Cancer Association meeting.

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."

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 June 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 $20.8 million, down sequentially from $24.1 million. Cash used in operating activity ws $4.7 million. No debt (paid off in June), but had $5.1 million in accounts payable and a $12.8 million milestone liability. . In January raised $1.3 million from the existing facility.

Total operating expense was $4.4 million,consisting of $2.7 million for R&D and $1.7 million for general and administrative expense. Other expense was $0.2 million.

$16.6 million cash was used in operations in 2017.


When is milestone payment for Gen1 due? It is tied to the Phase 2 progression, which is not likely to happen until late 2019, and we can elect to pay that in stock.

Why stock price out of line with medical facts? We did have a trial failure in ThermoDox. People are not used to throwing good money after bad. We believe the subgroup hypothesis is solid. In the original study we did not understand how much variability there would be in the RFA application times. Of course there is skepticism of subgroup analysis, we think this is an exceptional case. People in the medical and investment committee should read the HEAT study paper.

Adam Feuerstein chart showing ThermoDox fell off the map after a certain amount of RFA? We are not familiar with that. See the publication in CCR. We now know more about RFA in liver cancer than any other company on the planet.

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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