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Dec 31, 2019
Celsion Q4 2019 Earnings Report
Celsion reported 2019 financial results and provided a business update.
Key Takeaways
Celsion reported a net loss of $16.9 million for the year ended December 31, 2019, with operating expenses at $21.1 million. The company highlighted progress with ThermoDox® and GEN-1 development programs and a strong balance sheet, anticipating key milestones in 2020.
The pivotal 556-patient global Phase III OPTIMA Study in HCC was fully enrolled in August 2018.
The second of two preplanned interim efficacy analyses is expected in June 2020.
The OVATION 2 Study has completed enrollment of the first 15 patients in the Phase I portion of this 130-patient Phase I/II randomized study.
Celsion received $1.9 Million Allocation Through the New Jersey Technology Business Tax Certificate Transfer (NOL) Program; with an Additional $2 Million More Expected in 2020.
Celsion
Celsion
Forward Guidance
Celsion anticipates key milestones in 2020, including the interim efficacy analysis of the OPTIMA Study and continued progress in the OVATION 2 Study. They expect to receive net proceeds of $1.8 million from the sale of its 2017-2018 New Jersey state NOLs in the second quarter of 2020. An additional $2.0 million final allocation of NOL sales is fully expected in 2020.
Positive Outlook
- The Company expects to receive net proceeds of $1.8 million from the sale of its 2017-2018 New Jersey state NOLs in the second quarter of 2020.
- An additional $2.0 million final allocation of NOL sales is fully expected in 2020.
- The OPTIMA Study is well positioned for success at the next preplanned interim efficacy analysis.
- GEN-1 Receives Orphan Drug Designation from the European Medicines Agency.
- Strengthened Balance Sheet Through a Timely $4.8 Million Registered Direct Offering.
Challenges Ahead
- Unforeseen changes in the course of research and development activities and in clinical trials.
- The uncertainties of and difficulties in analyzing interim clinical data.
- The significant expense, time, and risk of failure of conducting clinical trials.
- The need for Celsion to evaluate its future development plans.
- Possible actions by customers, suppliers, competitors, regulatory authorities.