Galena Biopharma, Inc. (NASDAQ:GALE) and SELLAS Life Sciences Group
Ltd, a privately-held, oncology-focused, clinical stage
biopharmaceutical company, today jointly announced they have
entered into an all stock definitive merger agreement under which
SELLAS will merge into and become an indirect, wholly-owned
subsidiary of Galena. The combined company will be renamed SELLAS
Life Science Group, Inc. The merger will result in a combined
company focused on the development of novel treatments for cancer.
The combined company will feature a late-stage
pipeline led by novel immunotherapies targeting a broad range of
indications in hematology and solid tumors. SELLAS licenses the
rights to its lead asset, galinpepimut-S, (GPS), a novel WT1
antigen-targeting immunotherapy. GPS is initially being developed
for the treatment of acute myeloid leukemia (AML) and is Phase
3-ready in this setting. SELLAS has also successfully completed a
Phase 2 study of GPS in malignant pleural mesothelioma (MPM), and
its end-of-Phase 2 meetings with the U.S. Food and Drug
Administration (FDA) for GPS in both indications. For both AML and
MPM, SELLAS has been granted orphan drug designation from the FDA
and the European Medicines Agency (EMA) and been given FDA fast
track status. In addition, SELLAS is currently conducting two Phase
2 trials of GPS in multiple myeloma, as well as a combination trial
in ovarian cancer with nivolumab (OPDIVO®; Bristol-Myers Squibb),
and is currently preparing for additional combination trials for
GPS in combination with another checkpoint inhibitor. Galena’s lead
immunotherapy program, NeuVax™ (nelipepimut-S), is currently in
three, Phase 2, investigator-sponsored clinical trials in breast
cancer, and these trials will remain ongoing. Galena’s other
development programs, GALE-401, a controlled release version of
anagrelide that is Phase 3-ready, and GALE-301/GALE-302, an earlier
stage cancer immunotherapy program targeting folate binding
protein, are currently being evaluated for potential internal
development or strategic partnership.
“This transaction with Galena is an important step
for SELLAS and the advancement of our lead product candidate, GPS,
through important development milestones,” said Dr. Angelos
Stergiou, SELLAS’s Chief Executive Officer. “We believe GPS has the
potential to benefit a wide range of cancer patients and become an
important piece of the cancer immunotherapy treatment landscape as
both a monotherapy and in combination with other agents,
particularly checkpoint inhibitors. NeuVax strengthens our platform
and may provide important value inflections as the clinical trials
progress. The combined pipeline, with significant near term
milestones, creates multiple development and partnering
opportunities to create value as these programs evolve.”
Stephen F. Ghiglieri, Galena’s Interim Chief
Executive Officer and Chief Financial Officer, added, “Following a
thorough review of strategic alternatives and extensive search for
a merger partner, we selected SELLAS due to the depth of their
cancer immunotherapy pipeline which is clearly complimentary to
Galena’s development programs. In evaluating many alternatives,
SELLAS stood out in terms of its vision, strategic alignment with
Galena’s cancer immunotherapy programs, and near term opportunity
for value creation for our shareholders. We are encouraged by the
GPS data generated to date and the potential advancement of that
program into clinical trials in several indications. I, and our
board of directors, believe that patients and our shareholders have
the opportunity to benefit greatly from the clinical development
efforts that the combined companies will undertake.”
About the Proposed Transaction
On January 31, 2017, Galena announced the
initiation of a process to explore a range of strategic
alternatives focused on maximizing shareholder value. After a
thorough review of available alternatives, and extensive diligence
and negotiation with SELLAS, Galena’s board of directors
unanimously approved to enter into a definitive merger agreement
with SELLAS.
Under the terms of the merger agreement, existing
SELLAS shareholders will receive newly issued shares of Galena
common stock. On a pro forma basis, assuming completion of the
proposed merger, Galena stock and warrant holders are expected to
own approximately 32.5%, and SELLAS shareholders will own
approximately 67.5% of the combined company.
The transaction has also been unanimously approved
by the SELLAS board of directors and a majority of SELLAS
shareholders have agreed to vote in favor of the transaction. The
proposed merger is expected to close in the fourth quarter of 2017,
subject to the approval of Galena stockholders and other customary
closing conditions.
Galena’s financial advisor for the transaction is
Canaccord Genuity Inc. and Galena’s legal counsel are Paul Hastings
LLP and BeesMont Law Limited. SELLAS’ financial advisor for
the transaction is Guggenheim Securities, and SELLAS’ legal
counsels are Cooley LLP and Conyers Dill & Pearman.
Management and Organization
Angelos M. Stergiou, MD, SCD h.c., Chief Executive
Officer of SELLAS will become the Chief Executive Officer of the
combined company. Upon completion of the merger, Galena’s
board of directors will resign, and a new board of directors will
be constituted consisting of seven members that will include five
representatives appointed by SELLAS, two of whom will be
independent directors, and two representatives designated by Galena
subject to SELLAS’ approval. SELLAS’ management team will manage
the combined company.
Upon closing of the transaction, the name of the
combined company will become SELLAS Life Sciences Group, Inc. and
shares of the combined are expected to continue trading on the
NASDAQ Capital Market under a new ticker symbol, SLS.
Conference Call & Webcast
Galena and SELLAS will host a webcast and
conference call today at 5:00 a.m. P.T./8:00 a.m. E.T. to discuss
the proposed transaction. The live webcast will include
slides and can be accessed on Galena’s website under the Investors
section/Events and Presentations:
https://investors.galenabiopharma.com/investors/events-and-presentations/default.aspx.
The conference call can be accessed by dialing
(844) 825-4413 toll-free in the U.S., or (973) 638-3403 for
participants outside the U.S. The Conference ID number is:
66342165. The archived webcast replay will be available on
Galena’s website until the closing of the transaction.
About SELLAS Lead Product Candidate
Galinpepimut-S
Galinpepimut-S is a WT1 antigen-targeting
immunotherapy. The WT1 antigen is one of the most widely
expressed cancer antigens in multiple malignances.
Galinpepimut-S is a multi-peptide product with
heteroclitic-modifications that enhance the immunity and duration
of the immune response against the WT1 antigen independent of a
patient’s underlying genetics (HLA types) and elicits CD4 and CD8
immune responses with clinical efficacy and favorable safety
profile.
About SELLAS Life Sciences
Group
SELLAS Life Sciences Group Ltd is a late-stage
biopharmaceutical company focused on the development of novel
cancer immunotherapies and therapeutics for a broad range of cancer
indications. SELLAS’ lead product candidate, galinpepimut-S, is a
cancer immunotherapeutic agent licensed from Memorial Sloan
Kettering Cancer Center that targets a broad spectrum of
hematologic cancers and solid tumor indications. Galinpepimut-S is
expected to enter pivotal, Phase 3 clinical trials in patients with
AML and is also in various development phases in multiple myeloma
and ovarian cancer, and additional indications are expected as a
monotherapy or in combination with other immuno-oncology
agents. SELLAS recently received orphan drug designations
from the FDA, as well as the EMA, for galinpepimut-S in AML and
MPM; as well as fast track designation for AML and MPM from the
FDA.
SELLAS was founded in 2012 and is currently
headquartered in Hamilton, Bermuda, with additional operating
offices in New York City, NY.
For more information on SELLAS, please
visit www.sellaslifesciences.com.
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.
Safe Harbor Statements
Additional Information about the Proposed Merger
and Where to Find It
In connection with the proposed merger, Galena
Biopharma, Inc. and SELLAS Life Sciences Group Ltd intend to file
relevant materials with the Securities and Exchange Commission, or
the SEC, including a registration statement on Form S-4 that will
contain a proxy statement /prospectus / information
statement. Galena and SELLAS will mail the final
proxy statement / prospectus / information statement to their
respective stockholders. Investors and
stockholders of Galena and SELLAS are urged to read these materials
when they become available because they will contain important
information about Galena, SELLAS and the proposed merger.
The proxy statement /prospectus / information statement and other
relevant materials (when they become available), and any other
documents filed by Galena with the SEC, may be obtained free of
charge at the SEC web site at www.sec.gov. In addition, copies of
the documents filed with the SEC by Galena will be available free
of charge on the Company’s website at
www.galenabiopharma.com (under “Investors” – “Financials”) or
by directing a written request to: Galena Biopharma, Inc., 2000
Crow Canyon Place, Suite 380, San Ramon, CA 94583, Attention:
Investor Relations or by email to: ir@galenabiopharma.com.
Investors and stockholders are urged to read the proxy statement /
prospectus / information statement and the other relevant materials
when they become available before making any voting or investment
decision with respect to the proposed merger.
Non-Solicitation
This communication shall not constitute an offer to
sell or the solicitation of an offer to sell or the solicitation of
an offer to buy any securities, nor shall there be any sale of
securities in any jurisdiction in which such offer, solicitation or
sale would be unlawful prior to registration or qualification under
the securities laws of any such jurisdiction. No offering of
securities in connection with the proposed merger shall be made
except by means of a prospectus meeting the requirements of Section
10 of the Securities Act of 1933, as amended.
Participants in the Solicitation
Galena and its directors and executive officers and
SELLAS and its directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders
of Galena in connection with the proposed transaction. Information
regarding the special interests of these directors and executive
officers in the proposed merger will be included in the proxy
statement / prospectus / information statement referred to above.
Additional information regarding the directors and executive
officers of Galena is also included in Galena Annual Report on Form
10-K for the year ended December 31, 2016 and the proxy statement
for Galena’s 2017 Annual Meeting of Stockholders. These documents
are available free of charge at the SEC website (www.sec.gov), the
Investors section of Galena Biopharma’s website at the address
above, and from Investor Relations at Galena at the mailing address
described above.
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.
All statements, other than statements of historical
facts, included in this release regarding strategy, future
operations, future financial position, prospects, plans and
objectives of management are forward-looking statements. Examples
of such statements include, but are not limited to, statements
relating to the structure, timing and completion of the proposed
merger; the combined company’s listing on the NASDAQ Capital Market
after closing of the proposed merger; expectations regarding the
capitalization, resources and ownership structure of the combined
company; the combined company’s ability to successfully initiate
and complete clinical trials; anticipated milestones; the nature,
strategy and focus of the combined company; the development and
commercial potential of any product candidates of the combined
company; the executive and board structure of the combined company;
and expectations regarding voting by Galena’s and SELLAS’
stockholders. The combined company may not actually achieve the
plans, carry out the intentions or meet the expectations or
projections disclosed in the forward-looking statements and you
should not place undue reliance on these forward-looking
statements. Such statements are based on management’s current
expectations and involve risks and uncertainties. Actual results
and performance could differ materially from those projected in the
forward-looking statements as a result of many factors, including,
without limitation, risks and uncertainties associated with
stockholder approval of and the ability to consummate the proposed
merger through the process being conducted by Galena and SELLAS,
the ability to project future cash utilization and reserves needed
for contingent future liabilities and business operations, the
availability of sufficient resources of the combined company to
meet its business objectives and operational requirements, the fact
that the results of earlier studies and trials may not be
predictive of future clinical trial results, the protection and
market exclusivity provided by SELLAS’ intellectual property, risks
related to the drug discovery and the regulatory approval process
and the impact of competitive products and technological changes.
Additional risks and uncertainties relating to Galena and its
business can be found under the caption “Risk Factors” and
elsewhere in the Company’s SEC filings and reports, including in
Galena’s Annual Report on Form 10-K, filed with the SEC on March
15, 2017 and the Quarterly Report on Form 10-Q, filed with the SEC
on May 10, 2017 and in subsequently filed Form 10-Qs. Galena and
SELLAS each disclaim any intent or obligation to update these
forward-looking statements to reflect events or circumstances that
exist after the date on which they were made.
OPDIVO® is a trademark of Bristol-Myers Squibb
Company.
NeuVax is a trademark of Galena Biopharma, Inc.
Source: Galena Biopharma, Inc.
Contact:
Sellas Life Sciences Group
David Moser, JD
(201) 394-4523
info@sellaslife.com
Galena Biopharma, Inc.
Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com
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