Celsion Corporation Reports 2018 Financial Results
Celsion Enters 2019 with a Strong Balance Sheet, Clean Capitalization Structure and an Advancing Clinical Pipeline
Company to Hold Conference Call on
“Celsion had an extraordinary 2018, making meaningful progress with our ongoing development programs for ThermoDox® and GEN-1, as well as strengthening our balance sheet and cleaning up our capitalization structure. Among our many accomplishments, enrollment of our pivotal 556-patient global Phase III OPTIMA Study in HCC was completed ahead of projections, in
Data Monitoring Committee (DMC) Completed its Planned Safety and Data Review of Celsion’s Phase III OPTIMA Study. On
This DMC review analyzed blinded data from the intent-to-treat population, consolidated for both arms, which showed that median PFS for the OPTIMA Study had reached 21.2 months as of
The DMC consists of an independent group of medical and scientific experts responsible for reviewing and evaluating patient safety and efficacy data for the Company's Phase III OPTIMA Study. The DMC reviews study data at regular intervals in order to ensure the safety of all patients enrolled in the trial and to monitor the quality and overall conduct of the trial, including each site’s compliance with the study protocol. The OPTIMA Study's design and statistical plan incorporates two pre-planned interim efficacy analyses by the DMC with the intent of evaluating safety, efficacy and futility to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success to continue, modify or terminate the study.
Publication of ThermoDox® Study Results in the
The article, titled, “Focused Ultrasound Hyperthermia for Targeted Drug Release from Thermosensitive Liposomes: Results from a Phase I Trial,” included an evaluation of the TARDOX results and the safety, efficacy and utility of treatment with ThermoDox® plus targeted, non-invasive ultrasound in patients with solid liver tumors, with treatment plans based on patient-specific modeling.
The Phase I TARDOX study was carried out as a multi-disciplinary collaboration between
The Phase I TARDOX study demonstrated that focused ultrasound exposure with ThermoDox® resulted in increased chemotherapy concentrations within liver tumors that were an average of 3.7 times greater than preheating levels across all 10 patients in the study.
Presentation of GEN-1 Clinical Development Program at ASCO-SITC Clinical Immuno-Oncology Symposium. On
Dr. Thaker’s presentation highlighted the following:
- GEN-1 is a novel new approach 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.
- The Phase IB OVATION I Study, which evaluated escalating doses of GEN-1 (36 mg/m2, 47 mg/m2, 61 mg/m2 and 79 mg/m2) administered intraperitoneally in combination with three cycles of neoadjuvant chemotherapy (NAC) prior to interval debulking surgery, followed by three cycles of NAC in the treatment of newly diagnosed patients with Stage III/IV ovarian cancer, demonstrated median PFS of 21 months in patients treated per protocol (n=14) and 17.1 months for the intent-to-treat population (n=18) for all dose cohorts, including three patients who dropped out of the study after 13 days or less, each of which compared favorably to the PFS historical average of 12 months for women with Stage III/IV ovarian cancer.
- Of the 14 patients who were evaluable for response, 100% of patients administered NAC plus the two higher doses of GEN-1 experienced an objective tumor response (defined as a partial or complete response) compared to only 60% of patients given the two lower doses.
- Patients in the two higher dose cohorts also had a high surgery success rate, with 88% of these patients achieving the optimal outcome of a complete (R0) resection. 100% of patients treated at the highest dose cohort had a complete R0 resection.
- Pre- and post-treatment levels of key ovarian cancer biomarkers were also measured as part of this study and showed marked reduction in immunosuppressive response across multiple biomarkers post-treatment, including FOXP3 and IDO-1 – an outcome not previously observed with NAC treatment alone.
- Pathological changes were assessed as part of the study, with the density of markers measured in tissue sections assessed via immunohistochemistry staining. Among patients administered the high doses of GEN-1 (n=8), pre-treatment to post-treatment reductions in key biomarkers were observed (FoxP3 -62.5%; IDO-1 -60%; PD-1 -62.5%; PD-L1 -37.5%). Reductions were also observed in patients administered the lower doses of GEN-1 (n=4) for all but one of the four key biomarkers (FoxP3 -40%; IDO-1 -40%; PD-1 +25%; PD-L1 -37.5%). The ratio of CD8+ cells to the four key immunosuppressive cell signals increased following treatment in 60 - 80% of patients.
- The study showed no serious systemic toxicities. Dose-limiting toxicity was not reached in the OVATION I Study. The most common adverse events attributed to GEN-1 in the OVATION I Study were nausea, abdominal pain/cramping, fatigue, vomiting, diarrhea and neutropenia.
Celsion Signs Amendment to its
$7.0 millionin cash to EGWU within 10 business days of achieving the milestone; or $12.4 millionto EGWU, which is payable in cash, common stock of the Company, or a combination of either, within one year after achieving the milestone.
Additionally, the Amendment extends the Earnout Term as it applies to the Ovarian Cancer Milestone from seven (7) years to eight (8) years from the original signing date of the Asset Purchase Agreement. As consideration for entering into the Amendment, the Company will issue to EGWU 200,000 warrants to purchase common stock with an exercise price of
Elimination of Warrant Overhang. In
For the year ended
Net cash used for operating activities was
Research and development costs decreased by
General and administrative expenses were
Other expenses included a non-cash charge of
The Company realized
During the fourth quarter of 2018, the Company recognized a
During 2017, the Company recognized deemed dividends totaling
Year-End Conference Call
The Company is hosting a conference call to provide a business update and discuss year-end 2018 financial results at
Celsion Investor Contact
Executive Vice President, CFO and Corporate Secretary
|Condensed Statements of Operations|
|(in thousands except per share amounts)|
|Research and development||11,865||13,079|
|General and administrative||9,700||5,890|
|Total operating expenses||21,565||18,969|
Loss from operations
Other (expense) income:
|Gain from valuation of earn-out milestone liability||3,631||649|
|Loss from impairment of in-process research and development||(4,510)||(2,520)|
|Interest expense, investment income and other income (expense), net||(358)||(62)|
|Total other (expense) income, net||(1,237)||(1,933)|
|Net loss before income tax benefit||(22,032)||(20,402)|
|Income tax benefit||10,419||–|
|Deemed Dividend related to warrant modifications||–||(346)|
|Net loss attributable to common shareholders||$||(11,883)||$||(20,748)|
Net loss attributable to common shareholders per common share - basic and diluted
Weighted average common shares outstanding - basic and diluted
|Selected Balance Sheet Information|
|Cash and cash equivalents||$||13,354||$||11,444|
|Investment securities and interest receivable on investment securities||14,326||12,779|
|Prepaid expenses and other current assets||451||89|
|Total current assets||28,131||24,312|
|Property and equipment||185||176|
|In-process research and development||15,736||20,246|
|Other intangible assets, net||568||796|
|Total other assets||18,540||23,027|
LIABILITIES AND STOCKHOLDERS' EQUITY
|Accounts payable and accrued liabilities||$||5,607||$||5,700|
|Deferred revenue - current portion||500||500|
|Total current liabilities||6,107||6,200|
|Earn-out milestone liability||8,908||12,539|
|Notes payable - noncurrent portion||9,417||–|
|Deferred revenue and other liabilities - noncurrent portion||1,563||2,071|
|Additional paid-in capital||294,394||288,409|
|Accumulated other comprehensive gain (loss)||29||(10)|
|Less: Treasury stock||(85)||(85)|
|Total stockholders' equity||20,861||26,705|
Total liabilities and stockholders' equity
Source: Celsion CORP