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Dec 31, 2022
Celsion Q4 2022 Earnings Report
Reported financial results for the year ended December 31, 2022 and provided an update on its clinical development programs.
Key Takeaways
IMUNON reported a net loss for 2022 of $35.9 million, or $5.03 per share. The company ended the year with $38.9 million in cash, investments, accrued interest receivable and restricted cash, sufficient to fund operations into 2025.
Made significant progress during 2022 in advancing clinical programs in immuno-oncology with IMNN-001.
Completed evaluation of PLACCINE vaccines in non-human primates, demonstrating excellent immunological response and viral clearance.
Decision to raise capital earlier in the year strengthened balance sheet and extended operating runway into 2025.
Expect to report several value-creating developments during this period.
Celsion
Celsion
Forward Guidance
IMUNON anticipates filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for seasonal COVID-19 booster vaccine and also will select next pathogen target for PLACCINE modality.
Positive Outlook
- File an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for seasonal COVID-19 booster vaccine.
- Apply for a pre-IND consultation with the FDA to receive guidance on proposed program prior to submitting the IND.
- Select next pathogen target for PLACCINE modality.
- Establish the safety and efficacy of platform in a Phase 1 human study
- Seek to out-license this powerful technology to pharmaceutical companies
Challenges Ahead
- Unforeseen changes in the course of research and development activities and in clinical trials
- Uncertainties of and difficulties in analyzing interim clinical data
- Significant expense, time and risk of failure of conducting clinical trials
- Need for IMUNON to evaluate its future development plans
- Possible actions by customers, suppliers, competitors or regulatory authorities