Analyst Conference Summary

conference date: March 19, 2021 @ 8:00 AM Pacific Time
for quarter ending: December 31, 2020 (fourth quarter, Q4)

Forward-looking statements

Overview: ThermoDox failed. GEN-1 for ovarian cancer started its Phase 2 trial.

Basic data (GAAP):

Did not give Q4 numbers. For the full year 2020 had $0.5 million revenue, $21.5 million net loss or EPS of negative $0.67.

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

Net income was negative $ million, down sequentially from negative $8.1 million, and up from negative $ million year-earlier.

EPS was negative $, down sequentially from negative $0.24, and up from negative $ year-earlier.

Guidance:

Has a three-year cash runway.

Conference Highlights:

Michael H. Tardugno, Celsion's CEO, said: "Our Phase I/II OVATION 2 Study is over one-third enrolled. With 25 clinical sites to be activated by the end of the first quarter of 2021, encouraging trial data to date and the strong commitment of our clinical investigators, we expect to complete enrollment well before the end of 2021. Initial data at the 100 mg/m² dose cohort appear to be consistent with the directionally impressive results reported from our Phase Ib dose-escalating trial (the OVATION I Study) in ovarian cancer. Of 28 patients who completed interval debulking surgery, 81% of those treated with GEN-1 had an R0 resection, compared with 58% of control patients, a 41% improvement."

"Leveraging our clinical-stage TheraPlas platform, we envision a vaccine characterized by a single-plasmid DNA with multiple coding regions. Celsion’s plasmid vectors that are currently in development are designed to promote multiple antigens that are expressed by a single pathogen in combination with a potent immune modifier such as IL-12." Also exploring Covid therapies using the platform.

WPM note: Placcine DNA plasmid program is well behind other plasmid programs like Inovio's.

The OPTIMA Phase III study of ThermoDox plus RFA for liver cancer failed.

Celsion filed for patents for its next-generation DNA vaccines.

In September 2020 announced a common stock purchase agreement for the issuance and sale, from time to time, of up to $26 million of shares of common stock with Lincoln Park Capital Fund. In Q1 2021 raised $40 million in cash from a common stock sale.

As of March 2021, has enrolled approximately one-third of the anticipated 110 patients to be enrolled into the OVATION 2 Study. Currently, 28 patients have had their interval debulking surgery. 13 of 16, or 81%, of patients treated with GEN-1 had a R0 resection, which indicates a microscopically margin-negative complete resection in which no gross or microscopic tumor remains in the tumor bed. Seven of 12 patients, or 58%, of patients in the control arm had an R0 resection. These interim data represent a 41% improvement in R0 resection rates for GEN-1- patients compared with control arm patients and is consistent with the reported improvement in resection scores noted in the encouraging Phase I OVATION I Study, the manuscript of which has been submitted for peer-review publication.

On March 22, 2021, the Company announced receipt of Fast Track designation from the FDA for GEN-1. Believes could have PFS data in late 2022 or early 2023, and could get approval under Fast Track with trial amendments like combination endpoints.

Will continue to work on non-liver caner ThermoDox programs run by agencies or investigators.

Cash and equivalents ended at $17 million, down sequentially from $18 million. Debt includes $7 million milestone earnout liability and $4.6 million in outstanding notes. Has an ATM and shelf registration to raise cash if necessary, and raised $40 million in Q1 2021. As of March 2021 had $56 million cash.

Total operating expense was $19 million,consisting of $11 million for R&D and $8 million for general and administrative expense. Interest and other expense net $5 million.

Q&A summary:

Covid vaccine trial challenges? FDA may not require such large populations as were needed for the first approvals. We recognize it is a crowded field and we are new to vaccine technology, so our first goal is to get proof of concept and an IND from the FDA.

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