Celsion Corporation Reports First Quarter 2018 Financial Results and Provides Business Update
Supported with Solid Fundamentals and a Strong Balance Sheet
Company to Hold Conference Call on
“Celsion continues to make significant progress with our two ongoing clinical development programs for ThermoDox® and GEN-1. With sound fundamentals and a strong balance sheet, we are well positioned to complete enrollment in our ongoing 550 patient global, pivotal Phase III OPTIMA Study in primary liver cancer and to initiate our 130 patient Phase I/II randomized OVATION II Study in newly diagnosed patients with ovarian cancer in
ThermoDox® Highlighted at the International Liver Congress™ 2018 Symposium. On
Data Monitoring Committee Unanimously Recommended Continuation of the OPTIMA Study in Primary Liver after its Planned Safety and Data Review from 411 Patients; Enrollment Now at 85%. On
The DMC analysis in
Presentation of ThermoDox® HEAT Study Manuscript by Lead Author, Dr. Won
Dr. Tak’s presentation 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. The final OS analysis from the HEAT Study 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.
Corporate Presentations at Two Investor Conferences. In
- The B. Riley FBR Inaugural China Healthcare Investing & Partnering Symposium. The conference was held
March 15-17, 2018at The InterContinental Hotel Hangzhou, China.
- The Oppenheimer 28th Annual Healthcare Conference. The conference was held
March 20-21, 2018at The Westin New York Grand Centralin New York City.
The webcast of Celsion’s presentation at the Oppenheimer conference has been archived on the “News & Investors” section of Celsion’s corporate website at www.celsion.com.
- 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 2017and January 2018, the Company raised $5.2 millionin gross proceeds off its ATM Equity Facility with Cantor Fitzgerald.
For the quarter ended
Net cash used for operating activities was
Research and development costs were
General and administrative expenses were
As the Company paid off its Venture Debt Facility with
Quarterly Conference Call
The Company is hosting a conference call to provide a business update and discuss its first quarter 2018 financial results at
The call will be archived for replay on
Celsion Investor Contact
Sr. Vice President and CFO
|Condensed Statements of Operations|
|(in thousands except per share amounts)|
|Research and development||2,741||3,475|
|General and administrative||1,665||1,468|
|Total operating expenses||4,406||4,943|
|Loss from operations||(4,281||)||(4,818||)|
|Other (expense) income:|
|Loss from valuation of earn-out milestone liability||(270||)||(284||)|
|Investment income, interest expense and other income (expense), net||74||(58||)|
|Total other (expense) income, net||(196||)||(342||)|
|Net loss per common share - basic and diluted||$||(0.25||)||$||(3.09||)|
|Weighted average common shares outstanding - basic and diluted||17,684||1,671|
|Selected Balance Sheet Information|
|Cash and cash equivalents||$||2,285||$||11,444|
|Investment securities and interest receivable on investment securities||18,479||12,779|
|Prepaid expenses and other current assets||89||89|
|Total current assets||20,853||24,312|
|Property and equipment||175||176|
|In-process research and development||20,246||20,246|
|Other intangible assets, net||739||796|
|Total other assets||22,970||23,027|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||5,134||$||5,700|
|Deferred revenue - current portion||500||500|
|Total current liabilities||5,634||6,200|
|Earn-out milestone liability||12,809||12,539|
|Deferred revenue and other liabilities - noncurrent portion||1,945||2,071|
|Additional paid-in capital||289,810||288,409|
|Accumulated other comprehensive loss||(33||)||(10||)|
|Less: Treasury stock||(85||)||(85||)|
|Total stockholders' equity||23,610||26,705|
|Total liabilities and stockholders' equity||$||43,998||$||47,515|
Source: Celsion Corporation