Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
developing hematology and oncology therapeutics that address unmet
medical needs, today announced an update on the status of the
Company and its most advanced clinical development program.
Galena’s primary focus is the evaluation of strategic
alternatives initiated in the first quarter of this year.
With the support of Canaccord Genuity, Galena has had extensive
interactions with numerous companies to explore options for
monetizing some or all of its clinical development programs through
a license or sale of the assets, and/or transforming the Company
via a sale, merger, reverse merger, or business combination with
another company. While Galena is working through its strategic
alternatives process, management has significantly reduced the
staffing levels and certain operational expenses to preserve cash,
although work remains ongoing to advance its two core clinical
programs, GALE-401 and NeuVax™ (nelipepimut-S), and maintain their
value.
For NeuVax, Galena continues to support the ongoing investigator
sponsored studies, and today provided an update on the Phase 2b
trial in node positive and triple negative HER2 IHC 1+/2+ patients
in combination with trastuzumab. According to the latest report
from the clinical research organization (CRO) conducting the trial,
the study is nearly fully enrolled with 293 of the 300 patients
enrolled to date. At the current pace, the CRO expects
enrollment of the final 7 patients over the next few weeks with the
interim analysis performed by the Data Safety Monitoring Board to
occur six months after the final patient is
enrolled.
Separately, Galena filed an S-1 registration statement
(post effective amendment to S-3 on Form S-1) today to address our
current S-3 ineligibility. The purpose of the S-1
registration statement, as filed, is to register currently
outstanding warrants as we had notified warrant holders that we
would update the ineffective S-3 through such a filing. All
of the warrants are out of the money.
“While I am relatively new to Galena, I understand the road many
of our shareholders have traveled in their investment with the
Company, and I am very focused on seeking the best possible outcome
from our strategic process that will maximize the opportunity for a
financial return,” stated Stephen F. Ghiglieri, Interim Chief
Executive Officer and Chief Financial Officer. “Given the
challenges that Galena has faced, we are diligently addressing all
aspects of our business and proactively removing potential
impediments to executing a transaction. Reducing our expenses and
simplifying our capital structure is paramount for us as we work to
successfully complete the strategic alternative process. To
that end, I want to thank our shareholders for the ratification
vote we received on July 6, 2017, as it helps to clarify the
capital structure of the Company and should enable us to complete
our strategic alternatives process.”
Mr. Ghiglieri continued, “Thus far, we have had initial interest
in potential transactions from a number of companies. Though
this process is still evolving, we are committed to updating the
market as key events unfold. My goal is to find the best available
option, or options, for the Company and our assets to bring value
to our shareholders. We appreciate the patience and continued
support from our shareholders during this period.”
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed
cancer immunotherapy under evaluation to prevent breast cancer
recurrence after standard of care treatment in the adjuvant
setting. It is the immunodominant peptide derived from the
extracellular domain of the HER2 protein, a well-established target
for therapeutic intervention in breast carcinoma. The nelipepimut-S
sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs)
following binding to specific HLA molecules on antigen presenting
cells (APC). These activated specific CTLs recognize, neutralize
and destroy, through cell lysis, HER2 expressing cancer cells,
including occult cancer cells and micrometastatic foci. The
nelipepimut-S immune response can also generate CTLs to other
immunogenic peptides through inter- and intra-antigenic epitope
spreading. In clinical studies, NeuVax is combined with
recombinant granulocyte macrophage-colony stimulating factor
(GM-CSF).
NeuVax is currently in two breast cancer studies in combination
with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in
node positive and triple negative HER2 IHC 1+/2+
(clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial
in high risk, node positive or negative HER2 IHC 3+ patients
(clinicaltrials.gov identifier: NCT02297698). A Phase 2
clinical trial is also screening patients with NeuVax in patients
with ductal carcinoma in situ (DCIS) (clinicaltrials.gov
identifier: NCT02636582), and a Phase 2 trial is planned in
patients with gastric cancer.
About Breast Cancer1
New cases of breast cancer occur at an annual rate of 125 per
100,000 women in the U.S., with an estimated 246,660 new cases and
40,450 deaths in 2016. Approximately 89.7% of breast cancer
patients are expected to survive five years after diagnosis.
Approximately 12.4% of women will be diagnosed with breast cancer
at some point during their lifetime (2011 – 2013 data). The
prevalence data from 2013 showed an estimated 3,053,450 women
living with breast cancer in the United States. Of these
women, only about 25% are HER2 positive (IHC 3+). NeuVax targets
approximately 50%-60% of these women who are HER2 low to
intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission
with current standard of care, but have no available HER2-targeted
adjuvant treatment options to maintain their disease-free
status.
1National Cancer Institute Surveillance, Epidemiology, and End
Results Program
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company developing
hematology and oncology therapeutics that address unmet medical
needs. Galena’s pipeline consists of multiple mid-to-late-stage
clinical assets led by its hematology asset, GALE-401, and its
novel cancer immunotherapy programs including NeuVax™
(nelipepimut-S) and GALE-301/GALE-302. For more information, visit
www.galenabiopharma.com.
Forward-Looking Statements
This press release contains statements that include the words
“expect,” “intend,” “plan,” “believe,” “project,” “estimate,”
“may,” “should,” “anticipate,” “will” and similar statements of a
future or forward looking nature identify forward-looking
statements for purposes of the federal securities laws and
otherwise. Forward-looking statements are neither historical facts
nor assurances of future performance. Instead, they are based only
on our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, projections,
anticipated events and trends, the economy and other future
conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of our control. There are or will be important
factors that could cause actual results to differ materially from
those indicated in these statements. These forward-looking
statements include, but are not limited to, statements about the
potential outcome of voting on the proposals at our upcoming
special meeting of stockholders, strategic alternatives process
including the timeline, evaluation and completion of a potential
outcome of the process, the progress of the development of Galena’s
product candidates, patient enrollment in our clinical trials, the
progress and timing of our development activities, Galena’s current
and prospective financial condition, liquidity and access to
capital, present or future licensing, collaborative or financing
arrangements, expected outcomes with regulatory agencies, projected
market opportunities for product candidates, future expectations,
plans and prospects for the final agreements among the U.S.
Attorney’s Office for the District of New Jersey (“USAO NJ”) and
the Department of Justice (“DOJ”) and the Company, the settlement
terms among USAO NJ, DOJ and the Company, the settlement of any
claims that might be made by state agencies in the future, the
settlement terms with federal agencies such as U.S. Department of
Defense, the Office of Personnel Management, the Office of
Inspector General for the U.S. Department of Health and Human
Services, defense costs and potential settlements of shareholder
and derivative litigation, and other future events or that
otherwise relate to future periods. These forward-looking
statements are subject to a number of risks, uncertainties and
assumptions, including those identified under “Risk Factors” in
Galena’s Annual Report on Form 10-K for the year ended December 31,
2016, most recent Quarterly Reports on Form 10-Q, current reports
on Form 8-K, and the prospectus supplement filed with the SEC.
Actual results may differ materially from those contemplated by
these forward-looking statements. Galena does not undertake to
update any of these forward-looking statements to reflect a change
in its views or events or circumstances that occur after the date
of this press release.
NeuVax is a trademark of Galena Biopharma, Inc.
Source: Galena Biopharma, Inc.
Contact:
Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From Apr 2024 to May 2024
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From May 2023 to May 2024