On March 30, 2016 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the year ended December 31, 2015 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 30, 2016, View Source [SID:1234510127]). 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 a very productive 2015. We entered 2016 with a clear vision for leveraging two leading-edge technology platforms designed to enhance clinically powerful therapies. These approaches provide us with an opportunity to deliver cutting edge therapeutics that address prevalent cancers with high unmet needs, while at the same time driving growth for the Company and value for our shareholders," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "Over the past year, we have demonstrated the potential of ThermoDox and GEN-1, and we plan to build on this progress in 2016, as we focus our efforts on the pivotal Phase III OPTIMA Study and the Phase II Euro-DIGNITY Study for ThermoDox, and advancing GEN-1 in ovarian cancer."
Recent Developments
ThermoDox
Announced the launch of the OPTIMA Study in China. On March 5, 2016, the Company held an Investigators’ Meeting for the OPTIMA Study in Shanghai, China. Professor Ronnie T.P. Poon, MD, MBBS, MS, PhD, FRCS (Edin), FACS, Medical Director at the Hong Kong Integrated Oncology Center, Honorary Professor of Surgery at the University of Hong Kong Queen Mary Hospital, and member of the International Liver Cancer Association (ILCA) Governing Board provided the Keynote Address entitled "Treatment Strategies for Early/Intermediate HCC." Professor Poon discussed strategies for treating different stages of primary liver cancer. Investigators and their staff from 20 sites in mainland China and Hong Kong were in attendance. With the addition of these Chinese clinical sites, the Company expects to complete enrollment in the OPTIMA Study by the end of 2017. Results from the OPTIMA Study, if successful, will provide the basis for a global registration filing and marketing approval.
Received CFDA approval to conduct the OPTIMA Study in China. In December 2015, Celsion announced that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the ongoing Phase III OPTIMA Study at clinical sites in China. This approval by the CFDA represents another important validation of the Company’s development program for ThermoDox, which shows the potential for improvement in overall survival in HCC patients. The Phase III OPTIMA Study is expected to enroll up to 550 patients globally, and has been successfully enrolling patients at 50 clinical sites in 12 different countries in North America, Europe and Asia Pacific. The CTA approval will now allow Celsion to enroll patients at up to 20 additional clinical sites in China.
Presented DIGNITY Phase I/II ThermoDox Data at the 2015 San Antonio Breast Cancer Symposium. In December 2015, the Company presented results from its ongoing Phase I/II US DIGNITY Study of ThermoDox in combination with mild hyperthermia in patients with recurrent chest wall (RCW) breast cancer which demonstrated a combined local response rate of 62% among evaluable patients treated with ThermoDox. In addition to a local response rate of 62% among evaluable patients, a combined local response rate was observed in 46% of the intent-to-treat population (13/28), notably consisting of five patients demonstrating a durable local response lasting greater than three months. The Company plans to initiate a 70 patient Phase II study in Europe and Israel in less advanced, less heavily pretreated patients as part of the Euro-DIGNITY Trial. The Euro-DIGNITY Trial will evaluate ThermoDox plus radiation and hyperthermia in RCW breast cancer patients.
GEN-1 Immunotherapy
Reported translational data from its Phase Ib Study of GEN-1 Immunotherapy in recurrent ovarian cancer. In January 2016, the Company announced new translational data from its Phase Ib study of GEN-1 in patients with platinum-resistant ovarian cancer. The new data indicated that intraperitoneally-administered GEN-1 produces an immunologically distinct IL-12 protein that is localized at the tumor site and lasts for up to one week after a single treatment. In addition, concomitant increases in IFN-γ and TNF-α indicate that the IL-12 produced following treatment with GEN-1 treatment is immunologically active. Celsion intends to collect additional translational data, including cellular responses in primary tumor tissue and peritoneal ascites, in its ongoing OVATION Study, a Phase I dose escalation study in newly diagnosed ovarian cancer patients in the neoadjuvant setting.
Announced completion of enrollment of the first cohort of patients in the Phase 1b OVATION Study. In February 2016, the Company reported that the first two patients in the OVATION Study who completed treatment have shown promising results. Both patients reported stable disease with a dramatic drop in their CA-125 protein levels of 89% and 98%. Cancer antigen 125 (CA-125) is used to monitor certain cancers during and after treatment. A 50% reduction in CA-125 levels is considered meaningful. Both patients’ CA-125 levels were below the normal healthy level of 35 U/mL. In addition, both patients experienced successful surgical resections of their tumors with one patient reporting a R0 resection which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed.
Announced presentation of preclinical data for GEN-1 IL-12 Immunotherapy in combination with Avastin and Doxil at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016. In March 2016, the Company announced that preclinical data for GEN-1 in combination with Avastin and Doxil for the treatment of ovarian cancer will be presented at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2016. The presentation will summarize results from preclinical studies demonstrating significant synergistic anti-cancer effects when GEN-1 is combined with Avastin and Doxil, a current Standard of Care (SoC) for platinum resistant ovarian cancer patients. The preclinical studies show that GEN-1 when combined with Avastin and Doxil indicated a greater than 98% reduction in tumor burden when compared to the untreated control group. The findings represent a statistically significant reduction in tumor burden and disease progression when compared to the combination of Avastin and Doxil. These preclinical data will be used by the Company to support a comprehensive IND protocol filing for a Phase I/II clinical trial evaluating the combination in recurrent ovarian cancer later this year.
TheraSilence
Announced the issuance of a key U.S. Patent covering its novel TheraSilence RNA Program. In March 2016, the Company announced that the U.S. Patent and Trademark Office issued a key patent (U.S. Patent No. 9,254,334 B2) which provides broad intellectual property protection covering the therapeutic use of the Company’s proprietary TheraSilence lung-specific delivery system in a broad range of therapeutic entities, including the delivery of synthetically-generated inhibitory RNA (RNAi) such as small inhibitory RNAs (siRNAs), microRNAs, microRNA mimics, anti-microRNAs and related molecules that can regulate protein expression at the transcript level by exploiting endogenous cell mechanisms.
Corporate Development
Appointment of two new members to Celsion’s Board of Directors. In December 2015, the Company announced the appointment of Donald P. Braun, Ph.D. and Andreas Voss, M.D., to the Company’s Board of Directors. Dr. Braun brings over 30 years of research expertise in oncology, with a focus on immunotherapy and the effectiveness and impact of chemotherapy protocols on various cancers and tumor types, and currently serves as Vice President Translational Research and Chief Science Officer at the Cancer Treatment Centers of America. Dr. Voss currently serves as Vice President of Clinical Affairs in Europe at Caris Life Sciences, a biotechnology company focused on implementing personalized medicine in oncology through its liquid biopsy technology. Prior to joining Caris in 2010, he was responsible for the global clinical development of Avastin and a member of the Corporate Drug Safety Board at F. Hoffmann-La Roche.
Financial Results
For the year ended December 31, 2015, Celsion reported a net loss of $22.5 million, or $1.03 per share, compared to a net loss of $25.5 million, or $1.38 per share, in 2014. Operating expenses were $21.3 million in 2015 compared to $25.2 million in 2014. This decrease was primarily due to lower general and administrative expenses coupled with a $1.4 million one-time charge in connection with the acquisition of the assets of EGEN, Inc. in 2014.
Research and development costs were $14.7 million in 2015 compared to $15.0 million in the prior year 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. General and administrative expenses were $6.7 million in 2015 compared to $8.9 million in the prior year. This $2.2 million decrease in general and administrative expenses in 2015 is primarily the result of lower insurance premiums, reductions in personnel costs and reduced marketing expenses when compared to 2014.
Net cash used in operations was $20.8 million in 2015 compared to $21.4 million in the prior year. The Company ended 2015 with $20.1 million of total cash, investments and accrued interest on these investments.