Analyst Conference Summary

conference date: May 14, 2021 @ 7:00 AM Pacific Time
for quarter ending: March 31, 2021 (first quarter, Q1)

Forward-looking statements

Overview: Focus is now on GEN-1 for ovarian cancer enrolling a Phase 2 trial.

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 $na million, and down from negative $5.1 million year-earlier.

EPS was negative $0.09, down sequentially from negative $na, and up from negative $0.20 year-earlier.

Guidance:

none

Conference Highlights:

Michael H. Tardugno, Celsion's CEO, said: "Our Phase I/II OVATION 2 Study is more than 40% enrolled. With 23 clinical sites activated, encouraging trial data to date and the strong commitment of our clinical investigators, we hope to complete enrollment 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 OVATION I Study in ovarian cancer. In the OVATION 2 study 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"

On April 5, 2021 issued over 11 million shares at $1.30 for $13.9 million in cash proceeds.

The OPTIMA Phase III study of ThermoDox plus RFA for liver cancer failed in 2020.

In January 2021 Celsion filed for patents for its next-generation DNA vaccines. The PLACCINE technology platform is for a family of multi-cistronic vectors and polymeric nanoparticles.

In Q1 2021 raised $40 million in cash from a common stock sale. and $2.0 million in New Jersey NOL funds.

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.

Plans to increase the number of authorized shares, subject to a vote of shareholders.

Cash and equivalents ended at $53 million, up sequentially from $17 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.

Total operating expense was $5.5 million,consisting of $2.6 million for R&D and $2.9 million for general and administrative expense. Interest and other expense net $0.3 million.

Q&A summary:

Placcine platform, what needs to be done to get to dosing in humans? Still in early, preclinical work. Hopes to meet with FDA in 2021, move forward with an IND in 2022. Initially likely to be intramuscular injection, but later could be subcutaneous or nasal.

GEN-1 recruiting going well, but April was disappointing. May seems to be rebounding. Believes can complete enrollment by end of 2021.

We have done interesting preclinical studies of combination therapies with GEN-1, particularly with Avastin.

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