Sign in Subscribe
Pharmaceutical industry

Celsion Corporation Announces Financial Results and Update on ThermoDox(R) Clinical Trials

Strategic Insights

— 2 min read

Celsion Corporation, a leading oncology drug development company, announced financial results for the year ended December 31, 2010, and provided an update on its clinical trials of ThermoDox(R), a heat-activated liposomal encapsulation of doxorubicin for the treatment of hepatocellular carcinoma (HCC). The company is nearing completion of the 600-patient pivotal Phase III trial, known as the HEAT study, which is evaluating ThermoDox(R) in combination with radiofrequency ablation (RFA) for the treatment of non-resectable primary liver cancer. The HEAT study has been designated as a Priority Trial for liver cancer by the National Institutes of Health and has received Fast Track Designation from the FDA and Orphan Drug Designation in both the U.S. and Europe.

Key Takeaways:

  • Celsion reported a net loss of $18.8 million for the year ended December 31, 2010, compared to a net loss of $15.2 million for the same period in 2009.
  • The increase in net loss was primarily due to increased costs for investigator grants, monitoring, and milestone payments associated with higher patient enrollment levels for the HEAT study, as well as activities related to late-stage/commercial manufacturing for ThermoDox(R).
  • Celsion recorded a non-cash benefit of $574,000 related to a mark-to-market change in the common stock warrant liability in 2010, compared to a benefit of $732,000 in 2009.
  • The company received an $806,000 tax refund in the first quarter of 2010, which favorably impacted its cash flow.
  • The HEAT study is a 600-patient global Phase III trial being conducted at 75 clinical sites under the FDA's Special Protocol Assessment.
  • The study aims to evaluate the efficacy of ThermoDox(R) in combination with RFA compared to patients who receive RFA alone.
  • The primary endpoint for the study is progression-free survival (PFS), with a secondary confirmatory endpoint of overall survival.
  • A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the HEAT study is complete and 190 PFS events are realized in the study population.
  • Celsion has a partnership with Yakult-Honsha for the Japanese market and a partnership with Royal Phillips Electronics to jointly develop its heat-activated liposomal technology in combination with high-intensity focused ultrasound.
  • Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.

Statistics:

  • Net loss: $18.8 million (2010) vs. $15.2 million (2009)
  • Net loss per share: $1.52 (2010) vs. $1.43 (2009)
  • Operating costs: $1.7 million higher in 2010 due to increased costs for investigator grants, monitoring, and milestone payments
  • Non-cash benefits: $574,000 (2010) vs. $732,000 (2009)
  • Tax refund: $806,000 received in the first quarter of 2010
  • Cash and investments: $1.5 million at the end of 2010
  • HEAT study enrollment: nearing completion with 600 patients
  • HEAT study clinical sites: 75
  • HEAT study countries: global
  • HEAT study population: patients with non-resectable primary liver cancer

Sources:

  • Celsion Corporation
  • Marketwire
  • Celsion Corporation press release
  • National Institutes of Health
  • FDA
  • ClinicalTrials.gov
  • http://www.celsion.com

Read more