Celsion Corporation Reports Second Quarter 2013 Financial Results and Provides HEAT Study Update
Following the announcement on
As of the
- Overall Survival has not yet reached the median for the full HEAT Study population. A total of 226 deaths have been recorded through
June 30, 2013 . - Subgroup analysis based on RFA heating duration continues to suggest that ThermoDox® markedly improves Overall Survival, when compared to the control group, in patients if their lesions undergo RFA for 45 minutes or more. These findings apply to single HCC lesions (63% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent approximately 300 patients.
- While the Overall Survival data reported above should be viewed with caution since the HEAT Study has not reached its median point for Overall Survival analysis, there is a strong signal which our investigators consider to be encouraging and sufficient to warrant additional clinical investigation.
- Details of the retrospective OS findings will be presented at the upcoming
International Liver Cancer Association (ILCA) 2013 Annual Conference inWashington, D.C. onSeptember 14 , 2013.
"As we continue to follow patients in the HEAT Study to the secondary endpoint, Overall Survival, there is clear evidence that ThermoDox® can benefit patients when RFA is optimized," said Dr.
"We believe that the emerging data from our post hoc analysis of the HEAT Study may provide a rationale for continued development of ThermoDox® and a basis for discussion of a path forward for our HCC program with various regulatory agencies. While this important work continues, we have fully implemented our previously announced corporate restructuring program to adjust spending levels and headcount with the goal of reducing pressure on our cash resources while maintaining the necessary competencies important to the execution of our current business strategy," said
Recent Business Developments
In
- Emerging findings from the HEAT Study post-hoc analysis suggests that ThermoDox® improved progression-free survival (PFS) and overall survival (OS) in patients who had an optimized RFA procedure. The post-hoc analysis indicates that if patients' lesions undergo RFA for 45 minutes or more, they clearly benefitted from ThermoDox®. These findings apply to HCC lesions from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a sizable subgroup of approximately 300 patients. These findings were presented and discussed by two of the HEAT Study's lead investigators at scientific sessions of the
World Conference on Interventional Oncology onMay 16, 2013 and theEuropean Conference on Interventional Oncology onJune 19 and 20, 2013. The presentations and data are available on the Company's website at www.celsion.com. - The Company implemented a restructuring program to lower its operating costs to conserve capital. The program included the elimination of approximately one-third of
Celsion's workforce and the deferral of expenses associated with the Company's Phase II study of ThermoDox® in combination with RFA for the treatment of colorectal liver metastases (the ABLATE Study). - The Company engaged Cantor Fitzgerald & Co. to conduct a comprehensive review of merger and acquisition opportunities with the goal of identifying novel products with high potential, or companies, for
Celsion to acquire.
In
- The Company announced the issuance of additional patents covering its ThermoDox® technologies in four of the largest markets for primary liver cancer —
China ,Japan ,South Korea and Taiwan. These new patents extend proprietary protection to 2026. - The Company entered into a Securities Purchase Agreement with certain institutional investors, pursuant to which the Company sold, in an at-the-market registered direct offering, an aggregate of 6.3 million shares of its common stock for gross proceeds of
$9.8 million . There were no warrants issued as part of this financing transaction.
In
- The Company was notified that the
International Liver Cancer Association (ILCA) has accepted the HEAT Study abstract for webcast oral presentation at the plenary session of its annual meeting inSeptember 2013 inWashington , DC. Prospective and retrospective findings from the HEAT Study will be discussed by the Study's lead principal investigator inAsia , ProfessorRonnie Poon , MD, PhD, professor of surgery at theQueen Mary Hospital inHong Kong . - The Company reaffirmed its continued strategic partnership in
China with Zhejiang Hisun Pharmaceutical Company (Hisun), with the announcement of the signing of a Memorandum of Understanding for the future development of ThermoDox® and other liposomal formulations.
Financial Results
For the quarter ended
Net cash used in operations was
Research and development expenses decreased by
Quarterly Conference Call
The Company is hosting a conference call to provide a business update and discuss the second quarter 2013 financial results at
The call will be archived for replay on
About ThermoDox® and the Phase III HEAT Study
ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. ThermoDox® is being evaluated in a Phase III clinical trial for primary liver cancer (the HEAT study), a Phase II clinical trial for colorectal liver metastasis and a Phase II clinical trial for recurrent chest wall breast cancer. Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by radiofrequency ablation (RFA) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor. On
About
Investor Contact
Jeffrey W. Church
Senior Vice President and
Chief Financial Officer
609-482-2455
jchurch@celsion.com
| ||||||||
Condensed Statements of Operations | ||||||||
(in thousands except per share amounts) | ||||||||
(unaudited) | ||||||||
Three Months Ended |
Six Months Ended | |||||||
2013 |
2012 |
2013 |
2012 | |||||
Licensing revenue |
$ |
125 |
$ |
— |
$ |
250 |
$ |
— |
Operating expenses: |
||||||||
Research and development |
2,022 |
4,112 |
5,226 |
8,805 | ||||
General and administrative |
1,951 |
1,595 |
3,639 |
3,166 | ||||
Total operating expenses |
3,973 |
5,707 |
8,865 |
11,971 | ||||
Loss from operations |
(3,848) |
(5,707) |
(8,615) |
(11,971) | ||||
Other income (expense): |
||||||||
Gain (loss) from change in valuation of common stock warrant liability |
4,380 |
(447) |
8,660 |
(370) | ||||
Interest, dividends and other income (expense), net |
(111) |
50 |
(275) |
50 | ||||
Total other income (expense), net |
4,269 |
(397) |
8,385 |
(320) | ||||
Net income (loss) |
$ |
421 |
$ |
(6,104) |
$ |
(230) |
$ |
(12,291) |
Non-cash deemed dividend from beneficial conversion feature on convertible preferred stock |
─ |
─ |
(4,601) |
─ | ||||
Net income (loss) attributable to common shareholders |
$ |
421 |
$ |
(6,104) |
$ |
(4,831) |
$ |
(12,291) |
Net income (loss) per common share attributable to common shareholders |
||||||||
Basic |
$ |
0.01 |
$ |
(0.18) |
$ |
(0.10) |
$ |
(0.37) |
Fully Diluted |
$ |
─ |
$ |
(0.18) |
$ |
(0.10) |
$ |
(0.37) |
Weighted average shares outstanding |
||||||||
Basic |
54,392 |
33,236 |
48,632 |
33,211 | ||||
Fully Diluted |
61,280 |
33,236 |
48,632 |
33,211 |
| |||||
Selected Balance Sheet Information | |||||
(In thousands) | |||||
ASSETS |
2013 (Unaudited) |
|
|||
Current assets |
|||||
Cash and cash equivalents |
$ |
6,021 |
$ |
14,991 |
|
Short term investments and accrued interest |
42,913 |
8,104 |
|||
Other current assets |
639 |
554 |
|||
Total current assets |
49,573 |
23,649 |
|||
Property and equipment |
1,022 |
1,115 |
|||
Other assets |
|||||
Deposits and other assets |
396 |
567 |
|||
Patent license fees, net |
24 |
28 |
|||
Total other assets |
420 |
595 |
|||
Total assets |
$ |
51,015 |
$ |
25,359 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||
Current liabilities |
|||||
Accounts payable and accrued liabilities |
$ |
3,305 |
$ |
3,595 |
|
Deferred revenue — current portion |
500 |
— |
|||
Note payable - current portion |
1,905 |
1,410 |
|||
Total current liabilities |
5,710 |
5,005 |
|||
Common stock warrant liability |
4,734 |
4,284 |
|||
Note payable — non-current portion |
2,848 |
3,661 |
|||
Deferred revenue — noncurrent portion |
4,250 |
— |
|||
Other liabilities — noncurrent portion |
483 |
447 |
|||
Total liabilities |
18,025 |
13,397 |
|||
Stockholders' equity |
|||||
Preferred stock |
— |
— |
|||
Common stock |
618 |
380 |
|||
Additional paid-in capital |
190,963 |
165,276 |
|||
Accumulated other comprehensive loss |
(213) |
(127) |
|||
Accumulated deficit |
(155,698) |
(150,877) |
|||
Subtotal |
35,670 |
14,652 |
|||
Less: Treasury stock |
(2,680) |
(2,690) |
|||
Total stockholders' equity |
32,990 |
11,962 |
|||
Total liabilities and stockholders' equity |
$ |
51,015 |
$ |
25,359 |
SOURCE
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