Celsion Corporation Reports Third Quarter 2017 Financial Results and Provides Business Update
Recent Minimally Dilutive Financings Substantially Strengthen Balance Sheet and Provide Runway to Significant Clinical Milestones for ThermoDox® and GEN-1 Clinical Programs
Company to Hold Conference Call on
"We are extremely pleased with the meaningful developments in our two lead clinical programs and the capital infusion of over
"Our global Phase III OPTIMA Study evaluating ThermoDox® in primary liver cancer is currently enrolling patients in 14 countries worldwide. In
Publication of HEAT Study Manuscript. On
Additionally, the article explored the hypothesis prompted by these findings: ThermoDox®, when used in combination with Radiofrequency Ablation (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) is 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 translates 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.
The lead author of the HEAT Study manuscript is
R&D Day. On
Update on OPTIMA Study. On
DMC Review of OPTIMA Study. On
The Company also hosted Investigators Meetings with physicians and key opinion leaders in
R&D Day. On
Presented Final OVATION Study Findings at the
Key translational research findings from all evaluable patients are consistent with the earlier reports from partial analysis of the data and are summarized below:
- The intraperitoneal treatment of GEN-1 in conjunction with neoadjuvant chemotherapy resulted in dose dependent increases in IL-12 and Interferon-gamma (IFN-g) levels that were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients' systemic circulation. These and other post-treatment changes including decreases in VEGF levels in peritoneal fluid are consistent with an IL-12 based immune mechanism.
- Consistent with the previous partial reports, the effects observed in the 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.
- Analysis of peritoneal fluid by cell sorting, not reported before, shows treatment-related decrease in the percentage of immunosuppressive T-cell (Foxp3+), which is consistent with the reduction of Foxp3+ T-cells in the primary tumor tissue, and a shift in tumor naïve CD8+ cell population to more efficient tumor killing memory effector CD8+ cells.
- Of the fourteen patients treated 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. Seven out of eight (87%) patients in the highest two dose cohorts experienced a R0 surgical resection. All five patients treated at the highest dose cohort 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 eight patients who have received GEN-1 treatment over one year ago (cohort 1 - 3) and are being followed; only two patients' cancer has progressed. 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 as of
September 30, 2017is 18 months with the longest progression-free patient at 24 months.
- The Company raised
$17.0 millionin gross proceeds through the exercise of outstanding common stock warrants in October 2017.
July 2017, the Company completed a $5 millionregistered direct equity offering of shares of common stock, or pre-funded warrants in lieu thereof, and a concurrent private placement of warrants to purchase common stock with several institutional healthcare investors.
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 $6.6 million.
For the quarter ended
Net cash used for operating activities was
Research and development costs were
General and administrative expenses were
During the third quarter ended
During the nine months ended
Interest expense decreased by
Quarterly Conference Call
The Company is hosting a
conference call to provide a business update and discuss third quarter 2017 financial results at
The call will be archived for replay on
Celsion Investor Contact
Sr. Vice President and CFO
|Condensed Statements of Operations|
|(in thousands except per share amounts)|
|Three Months Ended||Nine Months Ended|
|Research and development||3,349||4,225||9,871||11,003|
|General and administrative||1,174||1,497||4,291||4,888|
|Total operating expenses||4,523||5,722||14,162||15,891|
|Loss from operations||(4,398||)||(5,597||)||(13,787||)||(15,516||)|
|Other income (expense):|
|Gain (loss) from valuation of common stock warrant liability||1,246||(662||)||670||(556||)|
|(Loss) from impairment of in-process research and development||(2,520||)||-||(2,520||)||-|
|Interest expense, investment income and other income (expense), net||1||(151||)||(84||)||(585||)|
|Total other income (expense), net||(1,273||)||(813||)||(1,934||)||(1,141||)|
|Deemed dividend related to warrant Modification||-||-||(346||)||-|
|Net loss attributable to common shareholders||$||(5,671||)||$||(6,410||)||$||(16,067||)||$||(16,657||)|
|Net loss per common share|
|Basic and diluted||$||(0.70||)||$||(3.22||)||$||(3.04||)||$||(9.27||)|
|Weighted average shares outstanding|
|Basic and diluted||8,055||1,993||5,172||1,796|
|Selected Balance Sheet Information|
|Cash and cash equivalents||$||2,685||$||2,624|
|Investment securities and interest receivable on investment securities||-||1,684|
|Prepaid expenses and other current assets||89||204|
|Total current assets||2,774||4,512|
|Property and equipment||143||463|
|In-process research and development||20,247||22,766|
|Other intangibles assets, net||852||1,023|
|Total other assets||23,084||25,874|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||5,497||$||5,363|
|Deferred revenue - current portion||500||500|
|Note payable - current portion||-||2,560|
|Total current liabilities||5,997||8,423|
|Earn-out milestone liability||12,518||13,188|
|Deferred revenue and other liabilities - noncurrent portion||2,199||2,513|
|Additional paid-in capital||262,390||248,168|
|Total stockholders' equity||5,287||6,725|
|Total liabilities and stockholders' equity||$||26,001||$||30,849|
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