Lion Biotechnologies, Inc. (OTCQB:LBIO) announced that Chairman and
CEO, Manish Singh, Ph.D., has issued the following letter to the
shareholders.
Dear Shareholders,
When Lion Biotechnologies merged with Genesis in July 2013, the
company had a strong scientific and clinical research position, but
lacked the business infrastructure and financial resources to fully
leverage it. Six months later, we have a solid balance sheet, a
team of seasoned executives, and the backing of some of the most
respected names in life science investing.
As we enter 2014, we also have ambitious plans to advance and
deepen our pipeline as we continue to expand operations and explore
strategic business development opportunities. Following is a
summary of the progress we made over the last six months, as well
as an overview of our objectives for 2014.
2013 Highlights
To improve our profile in the investment community, we enacted a
1-for-100 reverse stock split in September that brought our share
price to a more attractive level for institutional investors, while
reducing our outstanding common shares from 1.5 billion to 15
million, thereby providing a more attractive capital
structure. We also changed the company name from Genesis
Biopharma to Lion Biotechnologies, reflecting the transition to a
new management team and board of directors, and more importantly,
the adoption of a broader growth strategy.
In November, we raised $21.6 million (net) in a private
financing with institutions and accredited
investors, including Quogue Capital LLC, Perceptive Advisors
LLC, VenBio Select Advisor, Three Arch Opportunity
Fund, and Broadfin Capital LLC. We believe this capital
is sufficient to continue building a top-tier management team,
expand our licensed patent portfolio, establish manufacturing
capability, and fund clinical trials planned in multiple
indications well into 2015. Our company's prior substantial
debt has also been retired, further strengthening our financial
position.
Finally, we added two key executives to our management team late
last year: Peter Ho, Ph.D., MBA, director of business development;
and James Bender, Ph.D., vice president of product development and
manufacturing. Both bring to Lion distinguished business and
clinical development expertise that will play a significant role in
the advancement of Lion's growth strategy.
2014 Outlook
Over the next 12 months, we intend to advance and report on
various clinical trials and R&D programs that will demonstrate
the potential of tumor infiltrating lymphocyte (TIL) based
therapies and advanced TIL technology that we are developing.
Clinical Progress
Second Phase 2 clinical trial -- We
expect to provide an update in the first quarter on enrollment in a
second Phase 2 trial under our cooperative research and development
agreement (CRADA) with NCI. A prior Phase 2 trial, which was
conducted at NCI between 2003 and 2011, demonstrated a 49%
objective response rate (ORR) when TILs were given after treating
patients with chemotherapy to ablate their immune system.
Importantly, when Total Body Irradiation (TBI) was added to
this regimen, the ORR increased to 72%. We are optimistic that
results of this second, randomized trial comparing the impact of
TBI on TIL therapy will further validate the results from the
previous study.
Combination trials: Zelboraf +
TILs -- In the second or third quarter,
we expect to report initial data from another trial combining
TILs with Zelboraf as a first line treatment for melanoma, which is
also being conducted at NCI. Although BRAF inhibitors such as
Zelboraf have shown good tumor regression results, a resistant
population appears to grow very rapidly, and within 6-9 months
almost all patients experience recurring tumor growth. We believe
there may be an opportunity to combine TILs with Zelboraf to
significantly delay tumor progression in patients with the BRAF
mutation.
Combination trials: TILs + Checkpoint
inhibitors -- Bristol-Myer Squibb's Yervoy and
anti-PD1 antibodies have proven highly effective in "taking the
brakes off T-cells" by blocking or turning off a natural inhibitory
mechanism. Two investigator-sponsored pilot trials are being
conducted by Moffitt Cancer Center combining TILs with either PD-1
or Yervoy as a first line treatment for metastatic
melanoma. Although we are not directly involved in running
these combination trials, we expect to see significant improvements
in the clinical efficacy when data from these trials is reported
later this year. If the clinical efficacy data reflects the
improvements we expect to see we intend to move this into larger
company sponsored clinical trials.
Next Generation TILS -- We are
working with NCI under our CRADA on the development of a
technology that allows for selection of T-cells that exhibit the
greatest anti-tumor activity. Fewer of these more potent
T-cells are needed to achieve the same effect, potentially
resulting in a faster and less expensive treatment.
Business Development
Licensing of Intellectual
Property -- Our plan is to license the new
"next-generation" TILs technology from NCI/NIH within the next 3-6
months to support further clinical development of specific
treatments for melanoma and strengthen our intellectual property
portfolio.
Development Partnerships -- As data
from the trials discussed above are generated and published, we
believe there will be significant interest from pharmaceutical
companies (including those developing checkpoint inhibitors) in
using T-cells to develop new treatments. Because Lion
Bio is the only public company solely focused on T-cell based
therapies, we expect to attract significant interest in potential
partnering and other strategic business development
opportunities.
Stock Market Uplisting -- Lion Bio currently
meets the share price and shareholder equity criteria for listing
its common stock on a national exchange, either Nasdaq or the New
York Stock Exchange MKT market. Based on other requirements
that we expect to satisfy in the coming months, we expect to be
eligible for listing in the second half of 2014.
While we are currently focused on metastatic melanoma, we
believe that over time the T-cell technology that we are developing
can be used to develop treatments for other difficult cancers,
including ovarian and lung cancer. We are excited to be
playing an important role in the development of TIL-based
immunotherapies, which we believe have the potential to become a
standard of care in eradicating cancer.
In closing, I would like to thank you, our shareholders, for
helping to put Lion in a position to build on its exceptional
scientific foundation. I look forward to reporting on our
progress during 2014.
Sincerely,
Manish Singh, Ph.D.
Chairman and Chief Executive Officer
About Lion Biotechnologies
Lion Biotechnologies, Inc. is engaged in the development of
T-cells and engineered T-cells for the treatment of various
cancers. The company's lead product candidate is a
ready-to-infuse autologous T-cell therapy utilizing
tumor-infiltrating lymphocytes (TILs) for the treatment of patients
with Stage IV metastatic melanoma, and is based on a clinical CRADA
with the National Cancer Institute along with physician-sponsored
investigational therapy at the MD Anderson Cancer Center and the H.
Lee Moffitt Cancer & Research Institute. For more information,
please visit http://www.lionbio.com.
Forward-Looking Statements
This shareholder letter contains forward-looking statements that
are based on management's current expectations and beliefs and are
subject to a number of risks, uncertainties and assumptions that
could cause actual results to differ materially from those
described. All statements, other than statements of historical
fact, are statements that could be deemed forward-looking
statements, including statements regarding clinical results, our
ability to enter into additional licenses or strategic
partnerships, our ability to change the market on which our common
stock is listed, and other such expectations and results. No
forward-looking statement can be guaranteed and actual results may
differ materially from those we expect. Development of new product
candidates cannot be guaranteed, and there can be no guarantee that
any particular product candidate will become a commercial
product. The scientific information discussed in this letter
is preliminary and investigative. Forward-looking statements
involve significant risks and uncertainties, including those
discussed and more fully described in the Securities and Exchange
Commission reports filed by us, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Please refer to Lion Biotechnologies,
Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional
information on the uncertainties and risk factors related to our
business. Unless otherwise noted, Lion Biotechnologies, Inc. is
providing this information as of February 3, 2014, and expressly
disclaims any duty to update information contained in this
letter.
CONTACT: IR Contact:
Gitanjali Jain Ogawa
The Trout Group, LLC
646-378-2949
gogawa@troutgroup.com