Celsion Pipeline Review and Guidance

Note* This is our third time covering Celsion in 2017 our Feb. 22nd and June 8th reports are available in the “Our Research” section of the site.

Celsion Corporation (NASDAQ: CLSN) is an oncology drug company, focused on the development and commercialization of directed chemotherapy, DNA-mediated immunotherapy, and RNA based therapy products for the treatment of these cancers:

Primary liver cancer/hepatocellular carcinoma (HCC)

Recurrent chest wall (RCW) breast cancer

Ovarian cancer

Glioblastoma multiforme (GBM)

Lung cancer


Recent Events

Oct. 03, 2017. The company announced final clinical and translational research data from its OVATION Study, a Phase Ib dose escalating clinical trial combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced Stage III/IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.

  • 100% Disease Control; 86% Objective Response Rate and 86% R0 & R1 Surgical Resection Rate in All Patients Treated in Four Dose-Escalating Cohorts
  • Clear Evidence of Biological Activity Including Dose Dependent Increases in Inflammatory Cytokines (IL-12 and IFN-g), Decreases in VEGF Levels and No Dose Limiting Toxicities
  • Expert Advisory Board Endorses Randomized Phase II in Newly Diagnosed Stage III and IV Ovarian Cancer

Sept. 27, 2017. provided a detailed update for the Company’s 550 patient, multinational, double-blind, placebo-controlled, pivotal Phase III clinical study of ThermoDox® in combination with radiofrequency ablation for primary liver cancer (the OPTIMA Study) which include recent investigators meetings in Bangkok, Thailand and Shanghai, China.

  • OPTIMA Study Enrollment is Approaching 70%
  • Independent Data Monitoring Committee Provided Unanimous Recommendation to Continue Study in August 2017
  • Investigators Meetings in Thailand and China Attended by 70% of Investigators in China and Asia-Pacific


Pipeline Review

Products in Clinical Trials:

ThermoDox® uses LTSL (lysolipid thermally sensitive liposome) technology to encapsulate the commonly used cancer drug doxorubicin. The heat-sensitive liposome rapidly changes structure when heated to 40°C-45°C, creating openings that release doxorubicin directly into and around the targeted tumor. ThermoDox is currently being evaluated in clinical studies for primary liver cancer and recurrent chest (RCW) wall breast cancer.

GEN-1, uses TheraPlas™ technology platform to provide localized immunotherapy. GEN-1 is an interleukin-12 (IL-12) DNA plasmid vector formed into nanoparticles with a lipopolymeric delivery system. It is currently under evaluation for the treatment of ovarian cancer and glioblastoma multiforme (GBM).

Pre-Clinical Product Candidates:

Glioblastoma multiforme (GBM) is the most common malignant primary brain tumor and the most aggressive in the central nervous system, with only one-third of patients surviving for 1 year and less than 5% living beyond 5 years. Local delivery of interleukin-12 (IL-12) genes by GEN-1, in combination with the standard of care, offers a novel approach to GBM treatment.

Lung cancer is the second most common cancer in both men and women and the leading cause of cancer death worldwide. In a mouse lung tumor model, VEGFR-2 siRNA (short interfering RNA) was formulated with TheraSilence LNPs. Intravenous treatment resulted in a significant decrease in VEGFR-2 transcript and a significant reduction in tumors found in the lungs.

Bladder cancer is the fourth most common cancer in men and 12th most common cancer in women. A key difficulty in treating bladder cancer is delivering effective medicine to the bladder wall and muscle. In a recent study of ThermoDox in bladder models, it was demonstrated that warm water irrigation of the bladder can release high concentrations of doxorubicin throughout all layers of the bladder wall.


About Celsion Corporation

Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies, and RNA- or DNA-based therapies. The Company’s lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, 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 pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers.  Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies.


Q2 Financial Review

For the quarter ended June 30, 2017, Celsion reported a net loss of $4.9 million, or $(0.79) per share, compared to a net loss of $4.5 million, or $(2.63) per share, in the same period of 2016. Operating expenses were $4.7 million in the second quarter of 2017 compared to $4.9 million in the same period of 2016.  For the six-month period ended June 30, 2017, the Company reported a net loss of $10.1 million, or $(1.75) per share, compared to $10.2 million, or $(6.04) per share, in the same six-month period of 2016.  Operating expenses were $9.6 million in the first half of 2017 compared to $10.2 million in the same period of 2016.  Net cash used in operations was $7.3 million in the first half of 2017 compared to $9.0 million in the same period last year.  The Company ended the second quarter of 2017 with $3.6 million of total cash and investments, which was subsequently increased with proceeds from a $5 million registered direct offering completed in early July 2017.

Research and development costs were $3.0 million in the second quarter of 2017 compared to $3.3 million in the same period last year.  Research and development costs were $6.5 million in the first half of 2017 compared to $6.8 million in the same period last year.

General and administrative expenses were $1.6 million in the second quarter of 2017 compared to $1.5 million in the same period of 2016.


Stock Influences and Risk Factors

The company is reporting positive clinical trial results with some of its product candidates;

The potential market for the company’s product candidates is virtually immeasurable;

The company has a history of significant losses from operations and may incur significant losses for the foreseeable future;

Drug development is an inherently uncertain process with a high risk of failure at every stage of development;

The business depends on license agreements with third parties to permit them to use patented technologies;

Legislative and regulatory changes affecting the healthcare industry could adversely affect the company’s  business.


Stock Chart

In intra-day trading on Tuesday, October 3, 2017, CLSN shares were at $3.84 (+154.30%) on mid-day volume of 34M shares traded. The current RSI (14-day) is 90.31.

CLSN shares are trading above their 50-day and 200-day moving averages of $1.51 and $3.17 respectively.


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