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 reported financial results for
the first quarter of 2020 and provided a business update.
“The first quarter of 2020 brought unprecedented times with the
onset of the COVID-19 global pandemic. Our key priorities are to
focus on the health and safety of our patients, investigators,
employees and other stakeholders as well as diligently executing
our business operations. We have been fortunate to be able to
continue to progress our clinical development program for
galinpepimut-S (GPS), including our Phase 3 REGAL study in acute
myeloid leukemia (AML), our Phase 1/2 basket study in combination
with pembrolizumab (KEYTRUDA®), and our Phase 1 trial in
combination with nivolumab (Opdivo®) in malignant pleural
mesothelioma (MPM) despite the uncertainty and disruption caused by
the pandemic. Our activities around the REGAL study, including
those for additional site activations in the United States and
Europe, have continued unabated. Screening is continuing in the
basket study and dosing of enrolled patients is continuing in the
MPM Phase 1 study,” said Angelos Stergiou, MD, ScD h.c., President
and Chief Executive Officer of SELLAS. “Additionally, we are
continuing our business development efforts to pursue out-licensing
opportunities for further clinical development of nelipepimut-S
(NPS).”
First Quarter 2020 and Recent Pipeline
Highlights
Galinpepimut-S (GPS) Program
- In April 2020, SELLAS announced the formation of the Steering
Committee for its Phase 3 REGAL clinical trial of GPS in patients
with AML who have achieved complete remission after second-line
anti-leukemic therapy (CR2). 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 multi-center Phase 3 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.
- In February 2020, SELLAS announced positive follow-up data from
its Phase 1/2 study of GPS in CR2 AML patients. The final data show
a median overall survival (OS) of 21.0 months, at a median
follow-up of 30.8 months, in patients receiving GPS compared to 5.4
months in patients treated with best standard care (p-value <
0.02). GPS therapy continued to be well-tolerated throughout the
study.
- In February 2020, SELLAS announced the enrollment of the first
patient in an investigator-sponsored clinical trial of GPS in
combination with Bristol-Myers Squibb’s anti-PD-1 therapy,
nivolumab (Opdivo®), in patients with MPM.
- In January 2020, SELLAS announced that it commenced patient
screening for its pivotal Phase 3 REGAL study of GPS in patients
with AML in CR2.
Nelipepimut-S (NPS) Program
- In March 2020, SELLAS announced preliminary antigen-specific
immune response data from a Phase 2 randomized
investigator-sponsored trial of NPS in combination with
granulocyte-macrophage colony-stimulating factor (GM-CSF) in women
with ductal carcinoma in situ (DCIS) of the breast who are HLA-A2+
or A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are
pre- or post-menopausal. Preliminary data show an 11-fold increase
in a CD8 cytotoxic T-lymphocytes immune response in patients who
received a single dose of NPS compared to baseline. The final data
is being further analyzed by the National Institute of Health, MD
Anderson Cancer Center and the study principal investigator, Dr.
Elizabeth Mittendorf, MD, PhD of the Dana-Farber/Brigham and
Women’s Cancer Center, and will be presented at an upcoming medical
conference.
- In March 2020, SELLAS announced that final results from the
efficacy and safety data analysis of the Phase 2b independent
investigator-sponsored clinical trial of the combination of
trastuzumab (Herceptin®) +/- NPS targeting HER2 low-expressing
breast cancer patient cohorts, including patients with triple
negative breast cancer (TNBC), were recently published in the peer
reviewed journal, Clinical Cancer Research. With regard to the TNBC
patient cohort, the data analysis shows:- Disease-free
survival (DFS) landmark rate at 24 months for patients treated with
NPS plus trastuzumab (n=53) was 92.6% compared to 70.2% for those
treated with trastuzumab alone (n=44), a clinically and
statistically significant improvement.- There was a
statistically significant reduction of 71.9% (p=0.01) in the
frequency of clinically detected recurrences in patients treated
with the combination (NPS plus trastuzumab) versus trastuzumab
alone.- The combination was generally well-tolerated and
there were no clinicopathologic differences between the study
groups.
- In February 2020, SELLAS announced that it had finalized the
design and plan for a Phase 3 registration-enabling study of NPS in
combination with trastuzumab for the treatment of patients with
TNBC in the adjuvant setting after standard treatment, following
feedback from a Type C review with the FDA. SELLAS is actively
pursuing out-licensing opportunities to fund and conduct the future
clinical development of NPS.
Recent Corporate Highlights
- In April 2020, SELLAS retained PCG Advisory Inc., a leading
investor relations and digital strategies firm, to serve as an
advisor for investor relations and strategic communications.
- In February 2020, SELLAS announced the appointment of Dragan
Cicic, MD, as Senior Vice President, Clinical Development.
First Quarter 2020 Financial Results
Cash Position: As of March 31, 2020, cash and
cash equivalents totaled approximately $6.7 million, compared to
$2.6 million as of March 31, 2019. Net cash used in operating
activities was $6.8 million for the three months ended March 31,
2020, compared to $5.0 million for the three months ended March 31,
2019. Net cash provided by financing activities was $6.3 million
for the three months ended March 31, 2020, which was attributable
to $6.0 million in net proceeds from a registered direct offering
of shares of common stock and warrants to purchase common shares in
a concurrent private placement consummated in January 2020, and
$0.3 million from the collection of a stock subscription
receivable. During the three months ended March 31, 2019, the
Company generated $2.2 million of net cash from financing
activities from the exercise of certain common stock
warrants.
R&D Expenses: Research and development
expenses were $1.9 million for the first quarter of 2020, as
compared to $1.9 million for the three months ended March 31, 2019.
While relatively unchanged from the previous year quarter, for the
three months ended March 31, 2020 there was a $0.2 million increase
in clinical trial expenses, a $0.1 million increase in
manufacturing related expenses for GPS due to the Company’s ongoing
basket trial of GPS in combination with pembrolizumab and the Phase
3 REGAL study of GPS as a monotherapy in AML, and a $0.1 million
increase in other research and development expenses, partially
offset by a $0.2 million decrease in personnel related expenses due
to reduced headcount and a $0.2 million decrease in licensing
fees.
G&A Expenses: General and administrative
expenses were $2.2 million for the three months ended March 31,
2020, as compared to $2.5 million for the three months ended March
31, 2019. The $0.3 million decrease was primarily due to a $0.3
million decrease in legal fees, a $0.2 million decrease in
accounting fees, and a $0.1 million decrease in personnel related
expenses due to reduced headcount. These decreases were partially
offset by a $0.2 million increase in premiums for directors and
officers liability insurance and a $0.1 million increase in
outsourced consulting and public company costs.
Net Loss: Net loss attributable
to common stockholders was $4.2 million for the first 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 $5.0 million for the first quarter of 2019,
or a basic and diluted loss per share attributable to common
stockholders of $11.12.
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 Memorial Sloan Kettering Cancer Center 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, NPS, 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
TNBC 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, the potential for GPS as a drug development
candidate, plans for further development of and regulatory plans
for NPS, statements regarding the outcome of discussions with the
FDA regarding NPS and statements about the Company’s strategy and
plans for out-licensing NPS. 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®, Opdivo® and Herceptin® are registered trademarks of
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Inc., Kenilworth, N.J., USA, Bristol Myers Squibb and Genentech,
Inc., 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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