Celsion Corporation Reports Second Quarter 2017 Financial Results and Provides Business Update
"We are extremely pleased with the momentum that we have built and the meaningful developments in our two lead programs," said
OPTIMA Study Update. On
The Company hosted an Investigators Meeting with physicians in
In addition, the Company announced that patient enrollment in the 550 patient Phase III global study has reached over 60%. Based on current enrollment rates, the Company expects to complete enrollment of the OPTIMA Study by mid - 2018.
Announced Latest Translational Data from the OVATION Study Showing That Patients in All Cohorts Showed Convincing Evidence of IL-12 Gene Transfer and Immune System Activity. On
Key translational research findings from the first 12 of 15 patients enrolled in four patient cohorts are summarized below:
- The treatment-related changes in immune activating cytokines and pro-tumor VEGF and IFN- γ levels followed a dose-dependent trend and were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients' systemic circulation. The observed immunological changes are consistent with an IL-12 based mechanism.
- Effects observed in the immunohistochemistry (IHC) analysis were pronounced decreases in the density of immunosuppressive T-cell signals (FoxP3, PD-1, PDL-1, IDO-1) and increases in CD8+ cells in
the tumor microenvironment.
- The ratio of CD8+ cells to immunosuppressive cells was increased in approximately 75% of patients suggesting an overall shift in the tumor microenvironment from immunosuppressive to pro-immune stimulatory following treatment with GEN-1. An increase in CD8+ to immunosuppressive T-cell populations is a leading indicator and believed to be a good predictor of improved overall survival.
Presented OVATION Study Findings in Newly Diagnosed Advanced Ovarian Cancer Patients at the ASCO 2017 Annual Meeting. In
- Of the fourteen patients treated to date in the entire study, two (2) patients demonstrated a complete response, ten (10) patients demonstrated a partial response and two (2) patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate ("DCR") and an 86% objective response rate ("ORR"). Of the five patients treated in the highest dose cohort, there was a 100% objective response rate with one (1) complete response and four (4) partial responses.
- Fourteen patients had successful resections of their tumors, with nine (9) patients (64%) having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Of the five patients treated at the highest dose cohort, all five patients (100%) experienced a R0 surgical resection. Seven out of eight (87%) patients in the highest two dose cohorts experienced a R0 surgical resection.
- All patients experienced a clinically significant decrease in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells.
- Of the seven patients who have received GEN-1 treatment over one year ago and are being followed, only one patient's cancer has progressed after 11.7 months. This compares favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer that undergo neoadjuvant chemotherapy followed by interval debulking surgery. Of the remaining six patients who have been on the study for over one year, their average PFS is 16.4 months with the longest progression-free patient at over 22 months.
For the quarter ended
Research and development costs were
General and administrative expenses were
During the three and six months ended
Quarterly Conference Call
The Company is hosting a conference call to provide a business update and discuss second quarter 2017 financial results at
The call will be archived for replay on
|Condensed Statements of Operations|
|(in thousands except per share amounts)|
|Three Months Ended||Six Months Ended|
|Research and development||3,047||3,336||6,522||6,777|
|General and administrative||1,649||1,530||3,117||3,392|
|Total operating expenses||4,696||4,866||9,639||10,169|
|Loss from operations||(4,571||)||(4,741||)||(9,389||)||(9,919||)|
|Other income (expense):|
|Gain (loss) from valuation of common stock |
|Interest expense, investment income and other income (expense), net||(27||)||(199||)||(85||)||(434||)|
|Total other income (expense), net||(319||)||210||(661||)||(328||)|
|Deemed dividend related to warrant |
|Net loss attributable to common shareholders||$||(5,236||)||$||(4,531||)||$||(10,396||)||$||(10,247||)|
|Net loss per common share|
|Basic and diluted||$||(0.79||)||$||(2.63||)||$||(1.75||)||$||(6.04||)|
|Weighted average shares outstanding|
|Basic and diluted||6,629||1,723||5,949||1,697|
|Selected Balance Sheet Information|
|Cash and cash equivalents||$||3,629||$||2,624|
|Investment securities and interest receivable on investment securities||-||1,684|
|Prepaid expenses and other current assets||110||204|
|Total current assets||3,739||4,512|
|Property and equipment||257||463|
|In-process research and development||22,766||22,766|
|Other intangibles assets, net||909||1,023|
|Total other assets||25,660||25,874|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||6,456||$||5,363|
|Deferred revenue - current portion||500||500|
|Note payable - current portion||-||2,560|
|Total current liabilities||6,956||8,423|
|Earn-out milestone liability||13,764||13,188|
|Deferred revenue and other liabilities - noncurrent portion||2,287||2,513|
|Additional paid-in capital||258,105||248,168|
|Total stockholders' equity||6,649||6,725|
|Total liabilities and stockholders' equity||$||29,656||$||30,849|
Celsion Investor Contact
Jeffrey W. ChurchSr. Vice President and CFO 609-482-2455 email@example.com
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