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Mar 31, 2020
Celsion Q1 2020 Earnings Report
Celsion reported first quarter 2020 financial results and provided a business update.
Key Takeaways
Celsion Corporation reported a net loss of $5.1 million, or $0.20 per share, for the first quarter of 2020. The company continued to advance its clinical development programs with ThermoDox® and GEN-1 and maintained a strong balance sheet.
Phase III OPTIMA Study on track for interim data analysis in July.
GEN-1 immunotherapy showed encouraging results in the OVATION 2 Study.
GEN-1 received Orphan Drug Designation from the European Medicines Agency in April 2020.
Celsion received $1.8 million in non-dilutive funding from the sale of its New Jersey State Net Operating Losses.
Celsion
Celsion
Forward Guidance
Celsion expects to announce iDMC recommendations as soon as possible after the meeting. Celsion’s randomized Phase II OVATION 2 Study in advanced ovarian cancer patients is expected to commence in the fourth quarter of 2020 and is designed to demonstrate a 33% improvement in PFS (HR = 0.75) over current standard of care.
Positive Outlook
- Phase III OPTIMA Study is on track for interim data analysis in July 2020.
- GEN-1 immunotherapy continues to show encouraging results.
- GEN-1 received Orphan Drug Designation from the European Medicines Agency.
- The Company strengthened its balance sheet at a time of capital markets uncertainty.
- Initiated several cost containment measures to ensure that it has sufficient cash to fund operations and clinical development programs through the second quarter of 2021, which includes all major Phase III OPTIMA Study readouts.
Challenges Ahead
- Uncertainties of and difficulties in analyzing interim clinical data
- Significant expense, time, and risk of failure of conducting clinical trials
- Need for Celsion to evaluate its future development plans
- Possible acquisitions or licenses of other technologies, assets or businesses
- Possible actions by customers, suppliers, competitors, regulatory authorities