Lion Biotechnologies Announces Third Quarter 2015 Financial Results
November 05 2015 - 8:00AM
Lion Biotechnologies, Inc. (Nasdaq: LBIO), a biotechnology company
that is developing novel cancer immunotherapies based on
tumor-infiltrating lymphocytes (TIL), today reported financial
results for the third quarter and nine months ended September 30,
2015. For the third quarter and nine months ended September 30,
2015, the Company reported operating expenses of $2.9 million and
$7.5 million, respectively, compared to $2.4 million and $6.2
million, respectively, for the comparable 2014 periods. Research
and development expenses totaled $5.0 million and $12.1 million,
respectively, for the three and nine months ended September 30,
2015, compared to $0.4 million and $1.0 million, respectively, for
the same periods in 2014. During the nine months ended September
30, 2015, the Company raised $68.3 net proceeds from the sale of
its shares of common stock and received $9.6 million through the
exercise of warrants. As a result, as of September 30, 2015, the
Company held $110.1 million in cash and short-term investments.
Recent highlights include:
- Initiation of Phase 2 Study of LN-144 for the treatment of
refractory metastatic melanoma.
- Exclusive license from NIH to develop and commercialize TIL in
bladder, lung, breast and HPV-associated cancers.
- Positive updated data from NCI's Phase 2 study of TIL therapy
in the treatment of metastatic melanoma.
- Hiring of three new executives--a Chief Financial Officer, Vice
President of Process Development and a Vice President, Corporate
Development.
- Amendment of the Company's existing Cooperative Research and
Development Agreement (CRADA) with the National Cancer Institute to
include bladder, lung, triple-negative breast and HPV-associated
cancers.
- Exclusive, worldwide license agreement with the National
Institute of Health (NIH) for intellectual property related to two
patent-pending technologies to increase the potency and efficiency
of TIL production for the treatment of metastatic melanoma.
- Orphan drug designation received for the Company's lead product
candidate, LN-144, for the treatment of malignant melanoma.
- Relocation of its corporate offices to New York City.
"As we near the close of 2015, I'm pleased with the significant
progress we have made to date," stated Elma Hawkins, Lion's
president and chief executive officer. "Our focus in 2015 has been
to raise the necessary capital, expand our license and scientific
relationships, begin enrollment on a Phase 2 study and build out
our management team. I am delighted that we've achieved success in
all of these areas." She concluded, "TIL therapy continues to show
impressive results in the treatment of patients with metastatic
melanoma and I believe that the infrastructure we've put in place
this year will enable us to advance TIL therapy in our pursuit of
helping patients."
About Lion Biotechnologies
Lion Biotechnologies, Inc. is a clinical stage biotechnology
company focused on the development of cancer immunotherapy products
for the treatment of various cancers. The company's lead product
candidate is an adoptive cell therapy using tumor-infiltrating
lymphocytes (TIL) for the treatment of patients with refractory
metastatic melanoma, and is based on a clinical Cooperative
Research and Development Agreement with the National Cancer
Institute. TIL therapy is also being evaluated in
physician-sponsored clinical trials at MD Anderson Cancer Center
and Moffitt Cancer Center. For more information, please visit
http://www.lionbio.com.
Forward Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding, among other things, future operating and financial
performance, product development, market position and business
strategy. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections. Risks and uncertainties include, but are not limited
to, technological factors, such as technological advances or new
products and patents attained by competitors; challenges and
uncertainties inherent in new product development, including
uncertainty of clinical success and obtaining regulatory approvals;
uncertainty of commercial success for the company's new and
existing products; the ability of the company to successfully
execute its strategic plans; challenges to patents; significant
adverse litigation or regulatory investigation; government action,
including changes to applicable laws and regulations and global
health care reforms; trends toward health care cost containment;
changes in behavior and spending patterns of purchasers of health
care products and services. A further list and description of these
risks, uncertainties and other factors can be found in Lion
Biotechnologies, Inc. Annual Report on Form 10-K for the fiscal
year ended December 31, 2014, filed with the Securities and
Exchange Commission on March 16, 2015 and the company's subsequent
filings with the Securities and Exchange Commission. Copies of
these filings are available online at www.sec.gov or
www.lionbio.com. Any forward-looking statement made in this release
speaks only as of the date of this release. Lion Biotechnologies,
Inc. does not undertake to update any forward-looking statements as
a result of new information or future events or developments.
Condensed Statement of
Operations |
(unaudited) |
(in 000s, except per share
information) |
|
|
|
|
|
|
For the Three Months
Ended |
For the Nine Months
Ended |
|
September
30, |
September
30, |
|
2015 |
2014 |
2015 |
2014 |
|
|
|
|
|
Revenues |
$ -- |
$ -- |
$ -- |
$ -- |
|
|
|
|
|
Costs and expenses |
|
|
|
|
Operating expenses* |
2,660 |
2,449 |
7,259 |
6,155 |
Research and development** |
4,983 |
354 |
12,147 |
1,018 |
Total costs and expenses |
7,643 |
2,803 |
19,406 |
7,173 |
|
|
|
|
|
Loss from operations |
(7,643) |
(2,803) |
(19,406) |
(7,173) |
Interest income |
8 |
5 |
123 |
5 |
Net Loss |
$ (7,635) |
$ (2,798) |
$ (19,283) |
$ (7,168) |
|
|
|
|
|
Net Loss Per Share, Basic and
Diluted |
$ (0.16) |
$ (0.11) |
$ (0.44) |
$ (0.30) |
|
|
|
|
|
Weighted-Average Common Shares
Outstanding, Basic and Diluted |
47,272 |
26,633 |
43,399 |
24,108 |
|
|
|
|
|
* Includes $1,452, $658, $3,726,
and $1,905, respectively, in stock-based compensation costs |
** Includes $895, $282, $2,050,
and $817, respectively, in stock-based compensation costs |
|
|
|
|
|
|
|
|
|
|
Summary Balance Sheet
Data (in 000s) |
|
|
|
|
September 30, |
December 31, |
|
2015 |
2014
(1) |
|
(unaudited) |
|
Cash, cash equivalents and short-term
investments |
$110,146 |
$44,910 |
Total assets |
$112,224 |
$46,509 |
Stockholders' equity |
$109,369 |
$44,846 |
|
|
|
(1) Derived from audited
financial statements |
CONTACT: Investor Relations
The Trout Group
Elizabeth Broder
646-378-2945
ebroder@troutgroup.com
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