On March 16, 2017 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported financial results for the year ended December 31, 2016 and provided an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein (Press release, Celsion, MAR 16, 2017, View Source [SID1234518159]). The Company’s lead program is ThermoDox which is currently in Phase III development for the treatment of primary liver cancer and in Phase II development for the treatment of recurrent chest wall breast cancer. The Company’s immunotherapy program consists of GEN-1 and is currently in Phase I development for the localized treatment of ovarian cancer.

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"Celsion had an exceedingly productive 2016 as our accomplishments, one after another, established meaningful progress with respect to our two leading-edge technology platforms designed to enhance clinically powerful therapies. With sound fundamentals, the superb execution of our ongoing global, pivotal Phase III OPTIMA Study in primary liver cancer, continues to attract interest and support from the medical community, international regulatory agencies, and research organizations like the National Institutes of Health for this ground-breaking study," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "Our efforts in immuno-oncology are equally important. Over the past year, we have demonstrated the potential of our GEN-1 program to be an effective adjuvant, in both first and second-line ovarian cancer. Recruiting the immune system to work in combination with the standard of care in this patient population has been the goal of medical researchers worldwide. With GEN-1, we believe there is the potential for a break-through and we look forward to reporting comprehensive clinical findings and translational data from our nearly complete OVATION Study in the first half of 2017."

Recent Developments
ThermoDox
Announced the Independent NIH Analysis Showing Treatment with ThermoDox Plus RFA may Significantly Improve Overall Survival of Patients with Primary Liver Cancer. In November 2016, the Company announced the presentation of results from an independent retrospective analysis conducted by the National Institutes of Health (NIH) on the intent-to-treat population of the Company’s HEAT Study during The Interventional Oncology Series: Hepatocellular Carcinoma and Cholangiocarcinoma at the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA). The NIH analysis, which sought to evaluate the correlation between RFA burn time per tumor volume (min/ml) and clinical outcome, concluded that increased burn time per tumor volume significantly improved overall survival (OS) in patients with solitary lesions treated with RFA + ThermoDox compared to patients treated with RFA alone. More specifically, the analysis showed that a one unit increase in RFA duration per tumor volume improved OS by 20% in patients treated with optimized RFA + ThermoDox compared to RFA alone.These findings are consistent with Celsion’s analysis of the HEAT Study data showing that in patients treated with RFA for more than 45 minutes, standardized RFA plus ThermoDox resulted in a statistically significant improvement in overall survival of over two years when compared to standardized RFA alone.

Announced Support for the OPTIMA Study from the China FDA and Vietnam Ministry of Health. The Company discussed ThermoDox and the OPTIMA Study with regulatory agencies in two key markets, China and Vietnam. The Company met with the China Food and Drug Administration (CFDA) to review the ongoing Phase III OPTIMA Study and regulatory pathway for ThermoDox in China. CFDA was presented with the final overall survival data from the Chinese patient cohort of the HEAT study, which demonstrated a survival benefit in patients treated with ThermoDox plus optimized RFA versus optimized RFA alone. The CFDA informed the Company that if the ongoing Phase III OPTIMA Study is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union which is currently required for foreign company application. This would allow the Company to accelerate its plans for a regulatory filing in China and, if approved, provide for a significantly earlier launch date in China than originally expected. In addition, the Company’s management team met with the Ministry of Health in Vietnam and based on that meeting, it will move forward with launching additional trial sites for the OPTIMA Study in that country. The Company expects to have approximately 5 additional clinical trial sites in Vietnam activated in early 2017. Vietnam represents a significant market for
ThermoDox where HCC incidence rates are among the highest in the world.

Announced the Issuance of Two New Patents for ThermoDox. In January 2017, the Company announced the issuance of two patents which are directly applicable to the method of treating cancer using our current ThermoDox formulation. These new patents further strengthen the Company’s global patent portfolio around novel heat-sensitive liposome engineered to address a broad range of difficult-to-treat cancers.

Announced Collaboration with the Children’s Research Institute to Evaluate the Use of ThermoDox and High Intensity Focused Ultrasound in the Treatment of Solid Tumors in Children and Young Adults. In October 2016, the Company announced a collaboration with the Children’s Research Institute to conduct a clinical study of ThermoDox in combination with magnetic resonance-guided high intensity focused ultrasound to treat relapsed or refractory solid tumors in children and young adults. This investigator-sponsored Phase I clinical study is being partially funded by the National Institutes of Health and commenced in the fourth quarter of 2016.
GEN-1 Immunotherapy

Announced Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients. In January 2017, the Company announced data from the first four cohorts of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1 with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. The efficacy data included highly encouraging tumor response rates – 100% disease control rate (DCR) and 75% objective response rate (ORR), successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels.

Announced the Issuance of Two New U.S. Patents for GEN-1 Immuno-Oncology Product. In November 2016, the Company announced the issuance of two patents which expand the use of GEN-1 into additional cancer treatment modalities in combination with other chemotherapeutics and extends previous patent claims on the making of and composition of formulations consisting of our PPC delivery polymer and nucleic acids. These new patents further strengthen coverage of GEN-1 for the localized treatment of ovarian cancer and glioblastoma multiforme (GBM), which is already covered by a composition of matter patent in the United States.

Corporate Development
Raised $6.8 Million Through Two Equity Offerings in December 2016 and February 2017. The Company completed two equity offerings of shares of common stock, or pre-funded warrants in lieu thereof, to purchase common stock with institutional healthcare and retail investors totaling $6.8 million in gross proceeds.

Financial Results
For the year ended December 31, 2016, Celsion reported a net loss of $22.1 million, or $0.85 per share, compared to a net loss of $22.5 million, or $1.03 per share, in 2015. Operating expenses were $21.1 million in 2016 compared to $21.3 million in 2015. This decrease was primarily due to lower general and administrative expenses and clinical supply costs offset by higher clinical development costs for the Phase III OPTIMA Study.

Research and development (R&D) costs were constant at $14.6 million in 2016 and 2015. Clinical development costs for the OPTIMA Study were $5.6 million in 2016 compared to $3.6 million in 2015 due to higher patient enrollment, investigator grants and site initiation expenses in the trial. R&D costs for other development programs were lower as a result of the Company’s tighter clinical development focus around the pivotal Phase III OPTIMA Study for the treatment of primary liver cancer and the clinical development program for GEN-1 IL-12 immunotherapy for the localized treatment of ovarian cancer coupled with lower costs in 2016 associated with the production of ThermoDox to support the OPTIMA Study. General and administrative expenses decreased $0.2 million, from $6.7 million in 2015 to $6.5 million in the current year. This decrease in general and administrative expenses in 2016 is primarily the result of reductions in personnel costs and professional fees offset by $0.6 million of non-cash amortization expense related to the covenant not to compete from the June 2014 EGEN acquisition.

Other expenses included a non-cash charge of $1.4 million related to the impairment of in process research and development for the Company’s RNA delivery system (TheraSilence) offset by a $0.7 million reduction in the earn-out liability related to potential milestone payments for the TheraSilence asset. Interest expense decreased by $0.7 million in 2016 due to lower principal balances outstanding under the Company’s current debt facility.

Net cash used in operations was $18.4 million in 2016 compared to $20.8 million in the prior year. The Company ended 2016 with $4.5 million of total cash, investments and accrued interest on these investments. In February 2017, the Company raised an additional $5 million in gross proceeds under a secondary public offering.