Full Press Release Details
Lion Biotechnologies Reports First Quarter
2017 Financial Results
- Company to Host Conference Call at 5:00pm
San Carlos, CA - May 1, 2017 -- Lion Biotechnologies,
Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL)
technology, today reported its first quarter 2017 financial results and provided a corporate update.
"We started 2017 with a clear focus on execution toward
expanding our manufacturing capacity, our clinical program, and initiation of engagement with health authorities. During the first
quarter of 2017, we increased our manufacturing capacity and are now focused on expansion of our clinical program as well as access
to clinical data through collaborations. I am very excited about our recently announced collaboration with MD Anderson, which allows
us access to rare patient populations as well as a new method of manufacturing TIL using the MD Anderson process. Lion now has
strategic relationships with leading academic and governmental institutions in the U.S. researching TIL technology including the
NCI, MD Anderson, and the H. Lee Moffitt Cancer Center as well as one of a leading institution in Europe, the Karolinska Institute,
providing Lion the ability to pursue a much broader clinical program than would otherwise be possible as a standalone company,"
said Dr. Maria Fardis, PhD, MBA, Chief Executive Officer of Lion Biotechnologies. "With this new collaboration in place,
by year-end we may have partner-sponsored trials in pancreatic, glioblastoma, ovarian cancer, various sarcomas and melanoma combination
trials with three of the approved checkpoint inhibitors in addition to the three ongoing Lion-sponsored TIL clinical studies in
metastatic melanoma, head and neck and cervical cancers. This gives us a robust pipeline based on our TIL technology."
and Recent Highlights
Clinical Trial Progress:
First Quarter 2017 Financial Results
As of March 31, 2017, the Company held $147.2 million in cash
and cash equivalents and short-term investments, compared to $166.5 million as of December 31, 2016.
GAAP and Non-GAAP net loss
GAAP net loss for the quarter ended
March 31, 2017 was $20.7 million, or ($0.33) per share, compared to GAAP net loss of $6.9 million or ($0.14) per share for the
quarter ended March 31, 2016.
Non-GAAP net loss, which excludes amounts
related to stock-based compensation, for the quarter ended March 31, 2017 was $17.4 million, or ($0.28) per share, compared to
non-GAAP net loss of $5.1 million, or ($0.10) per share for the quarter ended March 31, 2016. The non-GAAP net loss for the quarter
ended March 31, 2017 excludes $3.3 million of non-cash stock-based compensation.
The Company believes that it is important
for investors to understand these non-cash charges as they materially impact the net loss and loss per share calculations. See
"Use of Non-GAAP Financial Measures" below for a description of the Company's Non-GAAP Financial Measures. Reconciliation
between certain GAAP and Non-GAAP measures is provided at the end of this press release.
GAAP and Non-GAAP expenses
GAAP research and development (R&D) expenses were $16.6
million for the quarter ended March 31, 2017, an increase of $12.4 million compared to the quarter ended March 31, 2016. The increase
in R&D expense is due to increased spending on clinical activities and expansion of manufacturing capabilities. This level
of spending is consistent with cell therapy companies at Lion's stage of clinical development. In addition, R&D-associated
stock option expenses were $1.4 million for the three months ended March 31, 2017. Non-GAAP R&D expenses were $15.2 million
for the quarter ended March 31, 2017, an increase of $11.6 million, compared to $3.6 million for the quarter ended March 31, 2016.
GAAP general and administrative (G&A) expenses were $4.3
million, an increase of $1.4 million compared to the quarter ended March 31, 2016. The increase in G&A expense is primarily
due to the increase in headcount and legal and outside services. Non-GAAP G&A expenses were $2.4 million, which excludes amounts
related to stock-based compensation of $1.9 million, for the quarter ended March 31, 2017 an increase of $0.8 million, compared
to $1.6 million for the quarter ended March 31, 2016.
Reconciliation between certain GAAP
and Non-GAAP measures is provided at the end of this press release.
Use of Non-GAAP Financial Measures
This press release contains non-GAAP
financial measures, including expenses adjusted to exclude certain non-cash expenses. These measures are not in accordance with,
or an alternative to, generally accepted accounting principles, or GAAP, and may be different from non-GAAP financial measures
used by other companies. The item included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures
for the periods presented in this press release relates to the non-cash stock-based compensation expense which may fluctuate from
period to period based on factors including the timing and accounting of grants for stock options and changes in the Company's
stock price which impacts the fair value of options granted. The Company believes the presentation of non-GAAP financial measures
provides useful information to management and investors regarding various financial and business trends relating to the Company's
financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures,
investors are provided with a more meaningful understanding of Lion's ongoing operating performance. In addition, these non-GAAP
financial measures are among those indicators the Company uses as a basis for evaluating operational performance, allocating resources
and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a
substitute for GAAP financial measures. To the extent this release contains historical or future non-GAAP financial measures, the
Company has also provided corresponding GAAP financial measures for comparative purposes. Reconciliation between certain GAAP and
non-GAAP measures is provided at the end of this press release.
Webcast and Conference Call
Lion will host a conference call today at 5:00 p.m. ET to discuss
these first quarter 2017 results. In order to participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257
(international) and reference the access code 8895265. The live webcast can be accessed under "Events and Presentation"
in the "Investors" section of the Company's website at http://www.lbio.com/ or you may use the link: http://edge.media-server.com/m/p/wfg3mt78.
A replay of the call will be available one hour after the end
of the call on May 1, 2017 until 4:30 p.m. ET on May 31, 2017. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406
(international) and reference the access code 8895265. The archived webcast will be available for thirty days in the Investors
section of Lion Biotechnologies' website at http://www.lbio.com.
About Lion Biotechnologies, Inc.
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 lymphocyte (TIL) technology being investigated for the treatment
of patients with refractory metastatic melanoma, metastatic squamous cell carcinoma of the head and neck, and metastatic cervical
carcinoma. For more information, please visit http://www.lionbio.com.
Forward-Looking Statements
This press release contains "forward-looking statements"
regarding, among other things, the Company's future goals, its operating and financial performance, additional studies and product
development, expansion of the company's research platform, and 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 if 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, the Company's ability to implement the
newly developed shorter manufacturing process, initiate a Phase 2 trial for LN-145 in 2017, its ability to continue to enroll patients
in the Phase 2 trial for LN-144, the initiation in 2017 by the Karolinska University Hospital of two Phase 1 trials and the conduct
thereafter of those trials, the further development of TIL under the CRADA. A further list and description of these and other risks,
uncertainties and other factors can be found in Lion Biotechnologies, Inc. most recent Annual Report on Form 10-K 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.
Stern Investor Relations, Inc.
Media Relations Contact:
Evan Smith/Kotaro Yoshida
212-850-5622/212-850-5690