Analyst Conference Summary

conference date: November 10, 2016 @ 8:00 AM Pacific Time
for quarter ending: September 30, 2016 (third quarter, Q3)

Forward-looking statements

Overview: Clinical-stage company has two cancer therapies in its pipeline. But low on cash.

Basic data (GAAP):

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

Net income was negative $6.4 million, down sequentially from negative $4.5 million, and down from negative $4.3 million year-earlier.

EPS was negative $0.23, down sequentially from negative $0.19, and down from negative $0.19 year-earlier.

Guidance:

Expects to use $4 to $4.5 million in cash for operations per quarter in the remainder of the year.

Conference Highlights:

"Over the last nine months, we have realized meaningful progress with respect to our two lead programs, ThermoDox and GEN-1. Importantly, we are well positioned to sustain this momentum through the balance of 2016 and beyond," said Michael H. Tardugno, Celsion's CEO. "The initial data from our GEN-1 program provides highly valuable insights into its favorable clinical and safety profile indicating a great deal of potential in both first and second-line ovarian cancer, and we look forward to reporting additional data from our ongoing OVATION study before year-end.

The final analysis of the Phase 2 trial of ThermoDox plus RFA (radio frequency ablation) showed very positive results in a well-defined subset of liver cancer (HCC) patients. Specifically, those that received above a minimum amount of RFA for certain sized tumors.

The OPTIMA Phase III study of ThermoDox plus RFA for liver cancer is being expanded with sufficient patients in China to allow for regulatory approval there if the results are positive. About half the world's new cases of liver cancer occur in China. It is currently over one-third enrolled, with 13 countries participating. Went to some length to refute naysayers about the possibility of success. Sounded believable to me. But the readout won't be until Q1 2018.

The NIH (National Institutes of Health) did an independent retrospective analysis of the Phase 2 trial and "concluded that increased RFA burn time per tumor volume substantially improved survival in patients with solitary lesions treated with RFA + ThermoDox® compared to patients treated with RFA alone." Data will be presented on November 28.

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 first two patient cohorts from the GEN-1 study preliminary data showed no dose-limiting toxicities and "highly encouraging tumor response rates." The independent DSMB reviewed the safety of the first three cohorts and recommended the study continue as planned with a higer dose fourth cohort. For details see Positive GEN-1 Data Reported.

Celsion expects the 4th, and final, Phase 1 cohort of the OVATION Study for newly diagnosed, advanced ovarian cancer to be fully enrolled this year." A manufacturing and supply agreement for GEN-1 was made with Hisun Pharmaceutical. In discussions with FDA to expand the study into a Phase 2 study. Has been contacted by "a few big pharma companies" about the results.

Cash and equivalents ended at $8.7 million, down sequentially from $14.4 million.

Operating expenses of $5.7 million consisted of $4.3 million for R&D and $1.5 million for G&A. Loss from valuation of common stock warrant liability was $0.7 million, interest expense was $0.2 million.

Believe maintaining a strong balance sheet is important. Last capital raise was in June for $6 million. Concerned about stock dilution. Called capital markets "difficult." Believes cash will last to support operations into Q2 2017, but will need to raise more cash.

Q&A:

Percent of enrollment in Optima study? About 40% enrolled. Rate of enrollment is picking up. But it is very difficult to bring on new sites in China.

GEN-1 total data set, Phase 1 timeline? Cohort 4 should be evaluated in February, then another 2 months for us to get the data. So topline data possibly in March, final report possibly in April.

R&D spend trend? We expect R&D expense to be near flat going forward, so we can stay in the $4 to $4.5 million cash spend envelope.

The European study would have a two-year enrollment period. This Dignity study is applying to begin in various nations in Europe, but will require more cash, so proceeding deliberately. But could start late in 2016 or early in 2017. It will be an open-label trial.

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