Celsion Corporation Reports Fourth Quarter and Full-Year 2017 Financial Results
Celsion Enters 2018 with Solid Fundamentals, a Strong Balance Sheet and
an Advancing Clinical Pipeline
Company to Hold Conference Call on
“Celsion had an outstanding year in 2017, making meaningful progress with our ongoing development programs for ThermoDox® and GEN-1, as well as strengthening our balance sheet. Entering 2018 with more than
Presentation of ThermoDox® HEAT Study Manuscript by Lead Author, Dr. Won
Publication of HEAT Study Manuscript. On
Additionally, the article explored the hypothesis prompted by these findings: ThermoDox®, when used in combination with RFA standardized to a minimum dwell time of 45 minutes (sRFA ≥ 45 min), may increase the overall survival (OS) of patients with hepatocellular carcinoma (HCC). The final OS analysis demonstrated that in a large, well bounded, subgroup of patients (n=285 patients, 41% of the previous 701 patient HEAT Study), treatment with a combination of ThermoDox® and standardized RFA provided an average 58% improvement in OS compared to standardized RFA alone. The Hazard Ratio (HR) was 0.63 (95% CI 0.43 - 0.93) with a p-value of 0.0198. In this large subgroup, median OS for the ThermoDox® plus standardized RFA group translated into a 25.4-month (more than 2.1 years) survival benefit over the standardized RFA-only group - totaling approximately 80 months (6-1/2 years, which is considered a curative treatment for HCC) for the ThermoDox® plus standardized RFA group versus 53 months for the standardized RFA-only group.
Presentation of GEN-1 Clinical Development Program and Recent Clinical and Translation Research Data by Ovarian Cancer Expert at
Dr. Thaker’s presentation highlighted the following:
- GEN-1 is a novel new approach that is designed to deploy the anti-cancer mechanism of the potent, broad-spectrum immunotherapy, IL-12, without the toxicities associated with the recombinant IL-12 protein.
- In a Phase I study of GEN-1, 14 newly diagnosed patients with Stage III/IV ovarian cancer were intraperitoneally administered GEN-1 plus neoadjuvant chemotherapy. Results from the study demonstrated immunological changes consistent with the ability of GEN-1 to increase local (peritoneal) levels of IL-12 and its downstream anti-cancer cytokines and reduction in vascular endothelial growth factor (VEGF; potent angiogenic factor that contributes to tumor angiogenesis) levels with little change in systemic circulation.
- The study showed no serious systemic toxicities. These clinical findings, including a partial or complete response in 86% of patients, R0 resections in 100% of patients treated at the highest dose cohort and recently reported progression-free survival (PFS) of over 21 months compared to historical controls for PFS of approximately 12 months, support further evaluation of GEN-1’s safety and efficacy in patients with Stage III/IV ovarian cancer.
Filing of Phase I/II Clinical Protocol for Evaluation of GEN-1 Immunotherapy to Treat Newly Diagnosed Ovarian Cancer. On
- Open label, 1:1 randomized design
- Enrollment in up to 90 patients with Stage III/IV ovarian cancer at ten U.S. centers
- Primary endpoint of improvement in PFS comparing GEN-1 with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone.
PFS for patients treated per protocol in the recently completed Phase IB OVATION Study continues to be followed. The Company expects to initiate enrollment in the Phase I portion of the OVATION II Study during the second quarter of 2018. The Phase I/II study will be powered to show a 33% improvement in the primary endpoint, PFS, when comparing GEN-1 with neoadjuvant chemotherapy to neoadjuvant chemotherapy alone.
R&D Day. On
- The Company raised
$17.0 millionin gross proceeds through the exercise of outstanding common stock warrants in early October 2017.
October 2017, the Company completed an underwritten equity offering of shares of common stock and warrants to purchase common stock with Oppenheimer & Co.The gross proceeds of the offering were approximately $6.6 million.
November 2017, the Company raised $3.9 millionin gross proceeds off its ATM Equity Facility with Cantor Fitzgerald.
For the year ended
Net cash used for operating activities was
Research and development costs were
General and administrative expenses were
For the year ended
During 2017, the Company recognized deemed dividends totaling
Interest expense decreased by
Quarterly Conference Call
The Company is hosting a conference call to provide a business update and discuss year-end 2017 financial results at
The call will be archived for replay on
Celsion Investor Contact
Sr. Vice President and CFO
|Condensed Statements of Operations|
|(in thousands except per share amounts)|
|Research and development||13,079||14,623|
|General and administrative||5,890||6,527|
|Total operating expenses||18,969||21,150|
Loss from operations
|Other (expense) income:|
|Gain from valuation of earn-out milestone liability||649||733|
|Loss from impairment of in-process research and development||(2,520||)||(1,444||)|
|Interest expense, investment income and other income (expense), net||(62||)||(693||)|
|Total other (expense) income, net||(1,933||)||(1,404||)|
|Deemed Dividend related to warrant modifications||(346||)||–|
|Net loss attributable to common shareholders||$||(20,748||)||$||(22,054||)|
|Net loss attributable to common shareholders per common
share - basic and diluted
|Weighted average common shares outstanding - basic and
|Selected Balance Sheet Information|
|Cash and cash equivalents||$||11,444||$||2,624|
|Investment securities and interest receivable on investment securities||12,779||1,684|
|Prepaid expenses and other current assets||89||205|
|Total current assets||24,312||4,513|
|Property and equipment||176||463|
|In-process research and development||20,246||22,766|
|Other intangible assets, net||796||1,023|
|Total other assets||23,027||25,874|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||5,700||$||5,363|
|Deferred revenue - current portion||500||500|
|Note payable - current portion||–||2,560|
|Total current liabilities||6,200||8,423|
|Earn-out milestone liability||12,539||13,188|
|Notes payable - noncurrent portion||–||–|
|Deferred revenue and other liabilities - noncurrent portion||2,071||2,513|
|Additional paid-in capital||288,409||248,169|
|Accumulated other comprehensive loss||(10||)||–|
|Less: Treasury stock||(85||)||(85||)|
|Total stockholders' equity||26,705||6,726|
|Total liabilities and stockholders' equity||$||47,515||$||30,850|
Source: Celsion Corporation