SELLAS Life Sciences Reports Corporate Highlights, Advancements for its Cancer Immunotherapy Pipeline and 2017 Financial Resu...
April 16 2018 - 09:00AM
SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (“SELLAS”), a
clinical-stage biopharmaceutical company focused on novel cancer
immunotherapies for a broad range of cancer indications, today
reported financial results for the year ended December 31, 2017 and
provided a business update.
“In recent months, we have made meaningful progress advancing
our business objectives, maturing SELLAS Life Sciences Group Ltd.
into a publicly-traded company following the business combination
and progressing our pipeline of cancer immunotherapies for patients
with limited treatment options,” said Angelos Stergiou, MD, ScD
h.c., President & Chief Executive Officer of SELLAS. “We are
particularly excited about our recent financing and the positive
interim results from the Phase 2b NeuVax™ + Herceptin study
announced earlier this month which we believe help position SELLAS
for continued success throughout the remainder of 2018. We
also look forward to commencing the Phase 1/2 clinical trial of
galinpepimut-S in combination with Keytruda® under our
collaboration and supply agreement with Merck and our planned Phase
3 Acute Myeloid Leukemia program.” Recent
Corporate and Pipeline Highlights
- In April 2018, SELLAS announced positive interim data from the
prospective, randomized, single-blinded, controlled Phase 2b
independent investigator-sponsored clinical trial (IST) of
trastuzumab (Herceptin®) +/-nelipepimut-S (NeuVax™) in HER 1+/2+
breast cancer patients in the adjuvant setting to prevent
recurrences.
- In March 2018, open label Phase 2 clinical and immunological
data for SELLAS’ lead product candidate, galinpepimut-S (GPS) in
patients with multiple myeloma (MM) was presented at the 2018
European Society for Blood and Marrow Transplantation (EBMT) 44th
Annual Meeting in Lisbon, Portugal. Median progression-free
survival (PFS) of 23.6 months was reported in the high-risk disease
setting, compared to historically inferior outcomes while on an
immunomodulatory drug (IMID) or proteasome inhibitor
post-autologous stem cell transplant maintenance.
- In March 2018, SELLAS appointed Barbara Wood as Executive Vice
President, General Counsel and Corporate Secretary.
- In March 2018, SELLAS entered into a definitive securities
purchase agreement to issue up to 10,700 shares of its Series A
convertible preferred stock and warrants to purchase 1,363,631
shares of its common stock in a private placement transaction to a
select group of institutional investors, in Europe and the United
States, for aggregate gross proceeds of $10.7 million. The
closing of the first tranche for approximately $6.0 million took
place on March 9, 2018. The closing of the second tranche for
approximately $4.7 million is expected to occur by the end of April
2018 following stockholder approval.
- In December 2017, SELLAS Life Sciences Group Ltd. (“SELLAS
Ltd.”), a privately-held Bermuda exempted company, completed a
business combination (the “Merger”) with Galena Biopharma, Inc.
(“Galena”). Upon completion of the Merger, Galena was renamed
“SELLAS Life Sciences Group, Inc.,” began trading under a new
ticker symbol “SLS” and the combined company now includes the
late-stage pipelines of novel cancer immunotherapies for both
hematologic and solid malignancies of SELLAS Ltd. and Galena.
- In October 2017, SELLAS Ltd. entered into a clinical trial
collaboration and supply agreement with Merck & Co. for a
combination clinical trial targeting multiple cancer types, in
which GPS will be administered in combination with Merck’s
anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a Phase 1/2 trial in
five cancer indications, including both hematologic malignancies
and solid tumors.
Year End 2017 Financial
Results
For accounting purposes, SELLAS Ltd. is
considered to have acquired Galena in the Merger; therefore, the
financial statements of Galena became those of SELLAS Ltd. and the
results reported are those of SELLAS Ltd.
Cash Position: As of December
31, 2017, cash and cash equivalents were $2.3 million, compared to
$6.0 million as of December 31, 2016. Net cash used in operating
activities was $11.0 million for the year ended December 31, 2017,
compared to $11.9 million for the year ended December 31, 2016.
R&D Expenses: Research and
development expenses were $6.1 million for the year ended December
31, 2017, as compared to $11.4 million for the year ended December
31, 2016. The $5.3 million decrease was primarily attributable to a
decrease of $2.5 million in fees due under licensing and
collaboration agreements, a decrease of $1.7 million in clinical
trial expense, a $1.3 million decrease in manufacturing expenses, a
$1.2 million decrease in consulting fees, and $0.2 million decrease
in regulatory expenses. These decreases were partially offset by a
$0.7 million increase in stock-based compensation and a $0.9
million increase in personnel related expenses. Overall, research
and development expenses were reduced in 2017 as SELLAS Ltd.
explored various strategic options.
G&A Expenses: General and
administrative expenses were $15.1 million for the year ended
December 31, 2017, as compared to $4.6 million for the year ended
December 31, 2016. The $10.5 million increase was primarily due to
$5.7 million of transaction costs related to the Merger and a $2.1
million increase in stock-based compensation from the acceleration
of restricted stock units, and a $1.5 million increase in personnel
related expenses due to an increase in headcount, $0.6 million
increase in accounting and audit fees, and $0.6 million in outside
consulting services. The $5.7 million of transactions costs consist
of $2.9 million of banking fees, $1.6 million in legal fees,
$1.0 million incentive fee payable through approximately
$0.1 million in cash and the issuance of 119,672 shares of our
common stock upon consummation, and $0.2 million in accounting and
audit fees. The transaction costs incurred related to the Merger
are non-recurring expenses for the year 2017.
Non-recurring Severance Costs:
Severance costs incurred during the year ended December 31,
2017 include employee-related costs for severance of former Galena
employees of $1.9 million.
Net Loss: Net loss was $23.8
million and loss attributable to common stockholders was $24.4
million for the year ended December 31, 2017, or a basic and
diluted loss per share to common stockholders of $10.44, as
compared to a net loss and loss attributable to common stockholders
of $17.7 million for the year ended December 31, 2016, or a basic
and diluted loss per share to common stock holders of $18.66.
About SELLAS Life Sciences Group
SELLAS is a clinical-stage biopharmaceutical company focused on
novel cancer immunotherapeutics for a broad range of cancer
indications. SELLAS’ lead product candidate, galinpepimut-S (GPS),
is licensed from Memorial Sloan Kettering Cancer Center and targets
the Wilms Tumor 1 (WT1) protein, which is present in an array of
tumor types. GPS has potential as a monotherapy or in
combination to address a broad spectrum of hematologic malignancies
and solid tumor indications. SELLAS has Phase 3 clinical trials
planned (pending funding availability) for GPS in two indications,
acute myeloid leukemia (AML) and malignant plural mesotheliomia
(MPM) and is also developing GPS as a potential treatment for
multiple myeloma and ovarian cancer. SELLAS plans to study
GPS in up to four additional indications. SELLAS has received
Orphan Drug designations from the U.S. Food & Drug
Administration (FDA), as well as the European Medicines Agency, for
GPS in AML and MPM; GPS also received Fast Track designation for
AML and MPM from the FDA. NeuVax™ (nelipepimut-S), a
first-in-class, HER2-directed cancer immunotherapy, is also being
investigated for the prevention of the recurrence of breast cancer
after standard of care treatment in the adjuvant setting.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Forward-Looking Statements
This press release contains forward-looking
statements, including, but not limited to, statements related to
the financial performance and expectations of SELLAS, results of
clinical studies and as to further development of Neuvax and GPS
for a broad range of cancer indications. These forward-looking
statements are based on current plans, objectives, estimates,
expectations and intentions, and inherently involve significant
risks and uncertainties. Actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which risks include, without limitation, risks and
uncertainties associated with immune-oncology product development
and clinical success thereof, uncertainties related to timing and
ability to obtain needed stockholder consent in a timely manner,
the uncertainty of regulatory approval, the uncertainty of
partnering its clinical assets, and other risks and uncertainties
affecting SELLAS and its development programs as set forth under
the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K
filed on April 12, 2018 and in its other SEC filings. Other risks
and uncertainties of which SELLAS is not currently aware may also
affect SELLAS’ forward-looking statements and may cause actual
results and the timing of events to differ materially from those
anticipated. The forward-looking statements herein are made only as
of the date hereof. SELLAS undertakes no obligation to update or
supplement any forward-looking statements to reflect actual
results, new information, future events, changes in its
expectations or other circumstances that exist after the date as of
which the forward-looking statements were made.
Investor Contact:Will O’ConnorStern Investor
Relations, Inc.212-362-1200ir@sellaslife.com
David Moser, JDSELLAS Life Sciences Group,
Inc.813-864-2571info@sellaslife.com
Source: SELLAS Life Sciences Group, Inc.
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