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Sep 30, 2020
Celsion Q3 2020 Earnings Report
Celsion reported financial results for Q3 2020 and provided a business update.
Key Takeaways
Celsion Corporation reported a net loss of $8.1 million, or $0.24 per share, for the quarter ended September 30, 2020, compared to a net loss of $5.5 million, or $0.25 per share, for the same period in 2019. The company continues to follow patients for overall survival in the Phase III OPTIMA Study and initiated the Phase II OVATION 2 Study of GEN-1 in advanced ovarian cancer.
Initiated Phase II OVATION 2 Study of GEN-1 in advanced ovarian cancer.
Continued following patients for overall survival in Phase III OPTIMA Study.
Engaged a global biometrics CRO for forensic statistical analysis of OPTIMA Study data.
Submitted OPTIMA Study clinical trial data to the National Institutes of Health (NIH) for independent evaluation.
Celsion
Celsion
Forward Guidance
Celsion expects to report findings from independent analyses of the OPTIMA Study before the end of the year, which will guide the decision to continue following patients to the final analysis in mid-2021. The company believes it has sufficient capital resources to fund its operations through the end of 2021.
Positive Outlook
- Completing enrollment of approximately 110 patients in the second or third quarter of 2021.
- Clinical updates will be provided throughout the course of treatment, including response rates and surgical resection scores.
- Celsion has engaged a global biometrics contract research organization (CRO).
- the Company has submitted all OPTIMA Study clinical trial data to the National Institutes of Health (NIH).
- Coupled with future planned sales of its New Jersey NOL’s, the Company believes it has sufficient capital resources to fund its operations through the end of 2021.
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, investors, competitors or regulatory authorities.