Analyst Conference Summary

conference date: May 15, 2020 @ 8:00 AM Pacific Time
for quarter ending: March 31, 2020 (first quarter, Q1)

Forward-looking statements

Overview: ThermoDox Phase 3 trial completed enrollment; nearing the second interim data readout, expected in July 2020.

Basic data (GAAP):

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

Net income was negative $5.1 million, sequentially from negative $na million, and down from negative $2.4 million year-earlier.

EPS was negative $0.20, sequentially from negative $na, and down from negative $0.12 year-earlier.

Guidance:

Has enough cash to see 2020 clinical data points, and into Q2 2021.

Conference Highlights:

Michael H. Tardugno, Celsion's CEO, said: "With our pivotal 556-patient Phase III OPTIMA Study in HCC fully enrolled, we now look forward to the preplanned interim efficacy analysis in July 2020. Our GEN-1 immunotherapy product continued to show encouraging results at the 100 mg/m² dose cohort in the OVATION 2 Study, which is consistent with the results reported from our earlier Phase Ib trial in advanced stage ovarian cancer. These findings were reinforced by strong progression-free survival when comparing study patients to a statistically validated synthetic control arm of matched patients from prior studies. This unique means of evaluating efficacy holds great potential for clinical research, and we plan to use it in upcoming discussions with the FDA as part of our goal to accelerate GEN-1 clinical development. In addition, GEN-1 received Orphan Drug Designation from the European Medicines Agency in April 2020."

The OPTIMA Phase III study of ThermoDox plus RFA for liver cancer is fully enrolled and reported its first interim efficacy analysis in early November 2019. The second interim analysis is due in July 2020, after 158 patient deaths reached in April. The hazard ratio for success at 158 events is 0.70 (p=0.022), which is below the hazard ratio of 0.65 (p=.02)observed for the 285 patients in the Prospective Subgroup treated with RFA > 45 minutes. Death rates are tracking the earlier subgroup. A final readout in 2020 will have the lowest bar for success and submitting an NDA. Median PFS for the OPTIMA Study reached 17.3 months as of August 2019. These blinded data compare favorably with median PFS of 16.8 months for the Prospective Subgroup treated with RFA > 45 minutes and followed prospectively for OS. Coronavirus produced only monitoring delays, should not affect timing of results. Starting to prepare the NDA so as to be able to submit within 6 months of a positive unveiling of data.

In February 2020 Celsion raised $4.8 million through a stock sale. Believe the operating runway now goes to mid 2021. In April 2020 will receiv $1.8 million through the New Jersey NOL (net operating loss) tax credit program. In Q4 2019 Celsion established a Subsidiary in China.

Beginning Phase 2 portion of the GEN-1 study will be delayed a few months, possibly until September, due to the pandemic, as manufacturing is postponed.. On March 23, 2020, Celsion announced the European Medicines Agency Committee for Orphan Medicinal Products recommended that GEN-1 be designated as an orphan medicinal product for the treatment of ovarian cancer. GEN-1 previously received orphan designation from the FDA. In March 2020, the Company announced highly encouraging initial clinical data from the first 15 patients enrolled in the ongoing Phase I/II OVATION 2 Study for patients newly diagnosed with Stage III and IV ovarian cancer. The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT). A comparison of 1b results to matched historical data approached statistical significance despite small number of patients. Talking with FDA about possible Fast Track and Breakthrough Therapy status.

ThermoDox plus ultrasound for breast cancer study was approved to start in the Netherlands in June 2019.

Met with Chinese authorities in Q3 2019 to discuss potential for ThermoDox there. China has the largest HCC patient population, 75% of the world total. Is considering a compassionate use program there.

Cash and equivalents ended at $15.7 million, up sequentially from $14.9 million. Debt includes $5.9 million milestone earnout liability and $9.8 million in outstanding notes. Raised an addition $6 million in Q1. Received $1.8 million NOL cash in April 2020. Has an ATM and shelf registration to raise cash if necessary.

Total operating expense was $4.9 million,consisting of $3.1 million for R&D and $1.8 million for general and administrative expense. Interest and other expense net $0,3 million.

Celsion continues to pursue non-dilutive sources of financing.

Expects to use abut $4 million in cash per quarter for the rest of the year.

Q&A summary:

Thermodox blinded PFS monitoring? Most recent is from first interim. In HEAT combined was 16.8 months. In Optima combined is 17.2. So PFS is following almost exactly. So we are encouraged.

Filing timeline if successful? We need to engage with the FDA. With a positive result from the DMC we would call the FDA for a pre-NDA meeting, then submit a formal letter we are already drafting. It takes 60 to 90 days to schedule a meeting. Then we can finalize the NDA, which probably would take 2 to 3 months. The preclinical and CNC sections of the application is already complete.

Dispersion in confidence interval for Hazard Ratio? That is due to the small number of subjects in the trial.

It takes up to a year to schedule a clinical batch of plasmids, that is why we are being cautious to ensure the manufacturing meets our needs.

Commercialization if success in July? COVID should not affect our commercial plans. It would take 12 to 14 months to launch, so the COVID situation should be better managed by then. China is the big market, with 50% of incidence. The world market is $billion plus. We will have our choice of partners, will look for the one with the best sales and marketing. But in the U.S. we will do it ourselves, unless there is a licensing opportunity that is better for shareholders.

COVID should not affect the Thermodox study, and it we have positive interim data we would continue to follow the patients, with counsel from the FDA. We also need to submit in China and Europe, which might require the longer follow-up.

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