SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (“SELLAS” or the
“Company”), a clinical-stage biopharmaceutical company focused on
the development of novel cancer immunotherapies for a broad range
of cancer indications, today provided a business update and
reported financial results for the quarter ended June 30, 2018.
“During the second quarter of 2018 we made
significant progress in laying the foundation for executing on our
clinical programs by closing the second tranche of our sale of
Series A Preferred Stock and warrants and commencing the process
for a follow-on equity offering. We are pleased to have closed that
equity financing last month which, together with the proceeds from
the sale of the preferred stock and warrants, provides us with
funding to begin to advance our pipeline of novel cancer
immunotherapies, focusing first on galinpepimut-S (GPS),” said
Angelos Stergiou, MD, ScD h.c., President and Chief Executive
Officer of SELLAS. “We plan to initiate our Phase 1/2 basket trial
of GPS in combination with Keytruda® in a number of indications by
the end of the third quarter with the first patient in during the
fourth quarter and are actively finalizing our clinical plan for a
Phase 3 study of GPS in patients with acute myeloid leukemia.
Looking ahead, we are also excited to present our Phase 2b data of
Herceptin® +/- NeuVax™ in an oral presentation at the 2018 Annual
Meeting of the European Society for Medical Oncology (ESMO) in late
October as well as optimizing our regulatory strategy for NeuVax
with U.S. and European regulatory authorities and exploring
strategic partnering alternatives around NeuVax,” continued Dr.
Stergiou.
Second Quarter 2018 and Recent Business
Highlights
- In July 2018, SELLAS completed an underwritten public offering
of common stock and pre-funded warrants, together with accompanying
common stock warrants, for aggregate net proceeds of approximately
$21.6 million, after deducting underwriting discounts, commissions
and offering expenses.
- In July 2018, SELLAS announced that data on the adjuvant
treatment of women with triple-negative breast cancer (TNBC) with
the combination of trastuzumab (Herceptin®) +/- NeuVax™ from a
Phase 2b independent investigator-sponsored trial (IST) will be
presented at the 2018 ESMO Annual Meeting October 19-23 in Munich,
Germany.
- In July 2018, SELLAS announced that the U.S. Food and Drug
Administration (FDA) granted Fast Track designation to GPS for the
treatment of multiple myeloma (MM).
- In June 2018, SELLAS presented interim data from an open-label
Phase 1 IST of GPS in combination with nivolumab in patients with
Wilms Tumor 1 (WT1)+ ovarian cancer in second or third remission
after salvage chemotherapy at the 2018 annual meeting of American
Society of Clinical Oncology (ASCO). Exploratory efficacy interim
data showed that GPS, when combined with a PD-1 inhibitor,
demonstrated a progression-free survival rate of 64% at one year in
an intent to treat group of 11 evaluable patients with WT1+ ovarian
cancer in second or greater remission. Among patients who received
at least three doses of GPS in combination with nivolumab, PFS at
one year was 70% (7/10). The historical rates with best standard
treatment do not exceed 50% in this disease setting.
- In June 2018, SELLAS announced that the Phase 2b independent
IST of Herceptin® +/- NeuVax™ in HER2 1+/2+ breast cancer patients
achieved its key clinical development objectives and was being
discontinued, based in part on the recommendation of the
independent Data Safety Monitoring Board to further develop the
NeuVax™ + Herceptin® combination for patients with TNBC.
- In June 2018, the Company was issued U.S. Patent No. 9,993,538
which is a method of use patent that is part of the patent
portfolio for the GALE-301 and GALE-302 folate binding protein
derived peptides. The method claims cover a dosing regimen to
induce an immune response against a tumor expressing folate
receptor alpha (FR-alpha) using the GALE-301 peptide (peptide of
FR-alpha epitope E39) and the GALE-302 peptide booster (peptide of
FR-alpha epitope E39’). The patent will expire on May 31, 2036
and provides further patent protection on the initial GALE-302
patent family, which expires in 2022.
- In May 2018, SELLAS announced that the FDA granted orphan drug
designation to GPS for the treatment of MM.
- In May 2018, SELLAS completed the second tranche of its $10.7
million private placement transaction.
- In April 2018, SELLAS appointed Gene Mack as Chief Financial
Officer and Treasurer.
Second Quarter 2018 Financial
Results
For accounting purposes, SELLAS Life Sciences
Group Ltd., a private Bermuda exempted company (SELLAS Ltd.), is
considered to have acquired the Company (which was formerly known
as Galena Biopharma, Inc. (Galena)) in the business combination
between SELLAS Ltd. and Galena (the Merger); therefore, upon the
Merger, the financial statements of Galena became those of SELLAS
Ltd. and the results reported are those of SELLAS Ltd. reflecting
the acquisition of Galena as of December 29, 2017.
Cash Position: As of June 30,
2018, cash and cash equivalents were $1.3 million, compared to $2.3
million as of December 31, 2017. Net cash used in operating
activities was $11.7 million for the first half of 2018, partially
offset by $8.9 million of net cash provided by financing
activities. On July 16, 2018, SELLAS completed an underwritten
public offering of common stock and pre-funded warrants, together
with accompanying common stock warrants, for aggregate net proceeds
of approximately $21.6 million, after deducting underwriting
discounts, commissions and offering expenses.
R&D Expenses: Research and
development expenses were $1.6 million for the second quarter of
2018, as compared to $1.8 million for the second quarter of 2017.
The decrease was primarily attributable to a decrease in licensing
fees, partially offset by a severance charge and an increase in
clinical and regulatory consulting services. Research and
development expenses for the six months ended June 30, 2018 were
$3.4 million, as compared to $4.0 million for the same period in
2017. The decrease was primarily attributable to a decrease in
licensing fees.
G&A Expenses: General and
administrative expenses were $4.9 million for the second quarter of
2018, as compared to $3.8 million for the second quarter of 2017.
The increase was primarily driven by an increase in legal fees
related to ongoing litigation and other legal matters related to
Galena’s business and operations, personnel related expenses and an
increase in insurance premiums. These increases were partially
offset by a decrease in stock-based compensation expense. General
and administrative expenses for the first half of 2018 were $8.8
million, as compared to $6.1 for the six months ended June 30,
2017. The increase during the period was primarily related to legal
and advisory fees associated with the Merger with Galena and
ongoing litigation and other legal matters related to Galena’s
business and operations.
Net Loss: Net loss attributable
to common stockholders was $8.5 million for the second quarter of
2018, or a basic and diluted loss per share attributable to common
stockholders of $1.26, as compared to a net loss attributable to
common stockholders of $5.9 million for the second quarter of 2017,
or a basic and diluted loss per share attributable to common
stockholders of $4.50. Net loss attributable to common stockholders
was $18.5 million for the six months ended June 30, 2018, or a
basic and diluted loss per share attributable to common
stockholders of $2.89, as compared to a net loss attributable to
common stockholders of $10.5 million for the prior period, or a
basic and diluted loss per share attributable to common
stockholders of $8.14.
About SELLAS Life Sciences Group,
Inc.
SELLAS is a clinical-stage biopharmaceutical
company focused on the development of 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 for
GPS in two indications, acute myeloid leukemia (AML) and malignant
pleural mesothelioma (MPM) and is also developing GPS as a
potential treatment for multiple myeloma (MM) and ovarian
cancer. SELLAS plans to study GPS in up to four additional
indications. SELLAS has received Orphan Drug designations for
GPS from the U.S. Food & Drug Administration (FDA) for AML,
MPM, and MM, as well as from the European Medicines Agency, for AML
and MPM; GPS also received Fast Track designation for AML, MPM and
MM from the FDA. SELLAS’ second product candidate, NeuVax™
(nelipepimut-S), is a HER2-directed cancer immunotherapy being
investigated for the prevention of the recurrence of breast cancer
after standard of care treatment in the adjuvant setting. NeuVax™
has received Fast Track status designation by FDA for the treatment
of patients with early stage breast cancer with low to intermediate
HER2 expression, otherwise known as HER2 1+ or 2+, following
standard of care.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Forward-Looking Statements
This press release contains forward-looking
statements. All statements other than statements of historical
facts are “forward-looking statements,” including those relating to
future events. In some cases, forward-looking statements can be
identified by terminology such as “plan,” “expect,” “anticipate,”
“may,” “might,” “will,” “should,” “project,” “believe,” “estimate,”
“predict,” “potential,” “intend,” or “continue” and other words or
terms of similar meaning. These statements, include, without
limitation, statements related to the timing and 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, risks and uncertainties related to
the timing of clinical trials, 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 Exhibit
99.1 in its Current Report on Form 8-K filed on July 18, 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 Contacts:Will
O’ConnorStern Investor Relations,
Inc.212-362-1200ir@sellaslife.com
David Moser, JDSELLAS Life Sciences Group,
Inc.813-864-2571info@sellaslife.com
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