SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (“SELLAS” or the
“Company”), a late-stage clinical 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,
2020.
“We are pleased that our ongoing studies for
galinpepimut-S (GPS) – our Phase 3 REGAL study in patients with
acute myeloid leukemia (AML) who have achieved complete remission
after second-line anti-leukemic therapy (CR2), our Phase 1/2 basket
study of GPS in combination with Merck’s pembrolizumab (KEYTRUDA®),
and the Phase 1 investigator-sponsored clinical trial (IST) of GPS
in combination with Bristol-Myers Squibb’s anti-PD-1 therapy,
nivolumab (Opdivo®), in patients with malignant pleural
mesothelioma (MPM) - are all proceeding on track despite
these challenging times,” said Angelos Stergiou, MD, ScD h.c.,
President and Chief Executive Officer of SELLAS. “During the second
quarter of 2020, we established the independent Data Monitoring
Committee (DMC) for the REGAL study comprised of esteemed members
of the medical, scientific and biostatistical communities as well
as a Steering Committee for the study.”
Dr. Stergiou added, “We are also pleased to have
strengthened our balance sheet with the closing of our private
placement financing in early August, as the proceeds will be used
to continue to progress our GPS program.”
Second Quarter 2020 Pipeline
Highlights
- Galinpepimut-S (GPS) Program
- In May 2020, SELLAS announced the
formation of the Independent Data Monitoring Committee (DMC) for
its pivotal Phase 3 REGAL clinical trial in AML CR2
patients. The DMC, comprised of an independent group of
medical, scientific and biostatistics experts, is responsible for
reviewing and evaluating patient safety and efficacy data for the
REGAL study. The DMC currently consists of four members: Moshe
Talpaz, M.D., Associate Director of Translational Research and
Associate Chief of the Division of Hematology/Oncology at the
University of Michigan Comprehensive Cancer Center and Chair of the
DMC; Thomas Fleming, Ph.D., Professor and former department chair
of the University of Washington Department of Biostatistics, Member
of the Fred Hutchinson Cancer Research Center, former Director of
the Statistical Center for HIV/AIDS Prevention Trial Network,
NIAID, Special Government Employee for the FDA, and for more than
25 years, a regular member of several FDA Advisory Committees;
Miguel-Angel Perales, M.D., Chief, Adult Bone Marrow Transplant
Service at Memorial Sloan Kettering Cancer Center (MSKCC); and
Stephane de Botton, M.D., Head of the Hematology Department at the
Gustave Roussy Cancer Campus in Paris, France.
- In April 2020, the Company
announced the formation of the Steering Committee for the REGAL
study. The Steering Committee currently consists of three members:
Dr. Hagop Kantarjian, MD, Professor and Chair of the Department of
Leukemia at The University of Texas MD Anderson Cancer Center, and
Principal Investigator at MD Anderson for the REGAL study and Chair
of the REGAL Steering Committee; Dr. Javier Pinilla-Ibarz, MD, PhD,
Director of Immunotherapy for Malignant Hematology at the H. Lee
Moffitt Cancer Center and member of the SELLAS Scientific Advisory
Board; and Dr. Moshe Yair Levy, MD, Director of Hematologic
Malignancies at the Texas Oncology - Baylor Charles A. Sammons
Cancer Center.
- Initial data readout from the MPM
IST is expected by the end of 2020; initial data from the Phase 1/2
basket study is expected in the first half of 2021; and the planned
interim safety and futility analysis in the REGAL study is expected
to occur by the end of 2021.
Recent Corporate Highlights
- In July 2020, SELLAS announced a
private placement priced at-the-market of 2,744,078 shares of its
common stock and accompanying warrants to purchase an aggregate of
up to 2,744,078 shares of common stock, at a combined purchase
price of $3.335 per share and accompanying warrant, to certain
institutional and accredited investors, with gross proceeds to the
Company of approximately $9.2 million before deducting the
placement agent fee and related offering expenses.
Second Quarter 2020 Financial
Results
R&D Expenses: Research and
development expenses were $2.3 million for the second quarter of
2020, as compared to $1.4 million for the second quarter of 2019.
Research and development expenses for the first half of 2020 were
$4.1 million, as compared to $3.2 million for the same period in
2019. The increases in research and development expenses during the
second quarter and first half of 2020 compared to the same periods
in 2019 were primarily due to clinical trial expenses incurred for
the REGAL study commencing in 2020.
G&A Expense: General and
administrative expenses were $2.0 million for the second quarter of
2020, as compared to $2.6 million for the second quarter of 2019.
General and administrative expenses for the first half of 2020 were
$4.2 million, as compared to $5.1 million for the same period in
2019. The decreases during the second quarter and first half of
2020 compared to the same periods in 2019 were primarily due a
reduction in legal fees and personnel related expenses.
Net Loss: Net loss attributable
to common stockholders was $4.4 million for the second quarter of
2020, or a basic and diluted loss per share attributable to common
stockholders of $0.66, as compared to a net loss attributable to
common stockholders of $4.1 million for the second quarter of 2019,
or a basic and diluted loss per share attributable to common
stockholders of $6.33. Net loss attributable to common stockholders
was $8.6 million for the first half of 2020, or a basic and diluted
loss per share attributable to common stockholders of $1.32, as
compared to a net loss attributable to common stockholders of $9.1
million for the first half of 2019, or a basic and diluted loss per
share attributable to common stockholders of $16.56.
Cash Position: As of June 30,
2020, cash and cash equivalents totaled approximately $3.3 million.
Following the end of the quarter, on August 4, 2020, the Company
received gross proceeds of approximately $9.2 million from the
Company’s sale, through a private placement priced at-the-market,
of shares of common stock and accompanying common stock warrants to
purchase shares of common stock.
About SELLAS Life Sciences Group,
Inc.
SELLAS is a late-stage clinical
biopharmaceutical company focused on the development of novel
cancer immunotherapeutics for a broad range of cancer indications.
SELLAS’ lead product candidate, GPS, is licensed from MSKCC and
targets the 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’ second product candidate, nelipepimut-S,
is a HER2-directed cancer immunotherapy with potential for the
treatment of patients with early stage breast cancer with low to
intermediate HER2 expression, otherwise known as HER2 1+ or 2+,
which includes triple negative breast cancer patients, 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 Company’s plans for further
development of and regulatory plans for GPS, including the timing
of clinical results and the potential for GPS as a drug development
candidate. 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 include, without limitation, risks
and uncertainties associated with the COVID-19 pandemic and its
impact on the Company’s clinical plans and business strategy, risks
and uncertainties associated with immune-oncology product
development and clinical success thereof, the uncertainty of
regulatory approval, 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 March
13, 2020 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.
Keytruda® and Opdivo® are registered trademarks
of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Inc., Kenilworth, N.J., USA, and Bristol Myers Squibb,
respectively, and are not trademarks of SELLAS. The manufacturers
of these brands are not affiliated with and do not endorse SELLAS
or its products.
Investor ContactsAdam
Holdsworth PCG Advisory 646-862-4607 adamh@pcgadvisory.com
Investor RelationsSELLAS Life Sciences Group,
Inc.917-438-4353info@sellaslife.com
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