SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (“SELLAS” or the
“Company”), a late-stage biopharmaceutical company focused on the
development of novel cancer immunotherapies for a broad range of
cancer indications, today provided a corporate update and reported
financial results for the quarter ended June 30, 2019.
“In recent months, we have made clinical
advancements across our pipeline of novel cancer peptide vaccines,
particularly with our program for galinpepimut-S (GPS) in
combination with anti-PD-1 therapies where we believe these
treatments may be synergistic, ,” said Angelos Stergiou, MD, ScD
h.c., President and Chief Executive Officer of SELLAS. “As we look
forward, we anticipate the following key milestones during the
remainder of the year: (i) initiation of our Phase 3 registrational
study of GPS in patients with acute myeloid leukemia (AML), (ii)
first patient dosed in the investigator-sponsored study of GPS in
combination with nivolumab in patients with malignant pleural
mesothelioma (MPM), and (iii) initial clinical data from our Phase
2 trial of nelipepimut-S (NPS) in ductal carcinoma in situ (DCIS).
Additionally, in the first quarter of 2020, initial clinical data
is expected from our Phase 1/2 basket study of GPS in combination
with KEYTRUDA® (pembrolizumab).”
Dr. Stergiou added, “Importantly, with our
recent follow-on offering, we strengthened our balance sheet in
order to support our clinical development programs through what we
believe will be value-creating inflection points. We look forward
to hosting our first R&D Investor Day in November where we will
present our GPS immunotherapy programs in greater detail,
particularly the Phase 3 AML study, and key opinion leaders will
discuss the current treatments of solid tumors and hematologic
malignancies and the potential role of GPS in treating these
devastating diseases.”
Recent Pipeline Highlights
- Galinpeptimut-S (GPS) Program
- The Company’s planned Phase 3 registrational randomized,
open-label study comparing GPS in the maintenance setting to
investigators’ choice of best available treatment in adult AML
patients who have achieved hematologic complete remission, with or
without thrombocytopenia (CR2/CR2p), after second-line antileukemic
therapy and who are deemed ineligible for or unable to undergo
allogeneic stem-cell transplantation is expected to be initiated in
the fourth quarter of 2019.
- In July 2019, the Company announced the dosing of the first
patient in its Phase 1/2 open-label, non-comparative, multicenter,
multi-arm study of GPS in combination with Merck’s anti-PD-1
therapy, pembrolizumab, in patients with selected WT1-positive
advanced cancers, including both solid tumors and hematologic
malignancies. The study is initially evaluating patients with
ovarian cancer (second or third line) and colorectal cancer (third
or fourth line), to be followed by patients with AML who are unable
to attain deeper morphological response than partial on
hypomethylating agents and who are not eligible for allogeneic
hematopoietic stem cell transplant and patients with triple
negative breast cancer (TNBC) (second line), and small cell lung
cancer (second line). The primary endpoints of this study
include safety and overall response rate, and secondary endpoints
include progression-free survival, overall survival and immune
response correlates. Initial clinical data is expected from the
study in the first quarter of 2020.
- In April 2019, the Company announced an agreement with Memorial
Sloan Kettering Cancer Center to conduct an investigator-sponsored
clinical trial of GPS in combination with Bristol-Myers Squibb’s
anti-PD-1 therapy, nivolumab, in patients with MPM. The Phase 1
open-label clinical study will enroll patients with MPM who harbor
relapsed or refractory disease after having received frontline
standard of care multimodality therapy with study drug provided by
both SELLAS and Bristol-Myers Squibb.
- In April 2019, SELLAS was granted its first licensed patent in
China, covering additional analog peptides of the Wilms’ tumor
oncogene protein (WT1), shown to induce enhanced T cell responses.
- Nelipepimut-S (NPS) Program
- In August 2019, SELLAS announced completion of enrollment in a
Phase 2 investigator-sponsored trial of NPS in combination with
granulocyte-macrophage colony-stimulating factor (GM-CSF) in women
with 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.
The Phase 2 trial is sponsored and operated by the National Cancer
Institute to study NPS’ potential clinical effects in earlier-stage
disease. The primary endpoint of the trial is the difference in the
frequency of newly induced NPS-cytotoxic T lymphocytes (CTL; CD8+
T-cell) in peripheral blood between the two arms of the study,
using a dextramer assay. Initial data from this trial is expected
by the end of 2019.
- In June 2019, immune response data from a preplanned analysis
in the cohort of patients with TNBC from the prospective,
randomized, single-blinded, controlled Phase 2b independent
investigator-sponsored clinical trial of NPS +/- trastuzumab
(Herceptin®) targeting HER2 low-expressing breast cancer patients
were presented at the 55th Annual ASCO Meeting. The data showed
highly clinically indicative increases in immune responses in the
NPS plus trastuzumab patients as compared to the trastuzumab-alone
arm.
Recent Corporate Highlights
- In June 2019, SELLAS announced the closing of an underwritten
public offering of (i) 26,367,200 shares of common stock together
with common stock warrants (common warrants) to purchase 26,367,200
shares of common stock and (ii) 73,632,800 pre-funded warrants,
with each pre-funded warrant exercisable for one share of common
stock, together with common warrants to purchase 73,632,800 shares
of common stock, for net proceeds of approximately $13.4
million.
R&D Investor Day
Scheduled
The Company will host its first R&D Investor
Day in New York, NY on Friday, November 15, 2019. The agenda
includes updates regarding the GPS Phase 3 AML clinical trial and
Phase 1/2 basket study in combination with pembrolizumab, and
scientific discussions from key opinion leaders in cancer
immunotherapeutics, including Dr. Hagop M. Kantarjian, MD,
Professor and Chair of the Department of Leukemia at the University
of Texas MD Anderson Cancer Center, and principal investigator of
the Phase 3 AML clinical trial.
Second Quarter 2019 Financial
Results
Cash Position: As of June 30,
2019, cash and cash equivalents totaled approximately $12.8
million, which includes the net proceeds of approximately $13.4
million from the Company’s underwritten public offering of shares
of common stock and pre-funded warrants and accompanying common
stock warrants to purchase shares of common stock consummated in
June 2019.
R&D Expenses: Research and
development expenses were $1.4 million for the second quarter of
2019, as compared to $1.6 million for the second quarter of 2018.
The $0.2 million decrease was primarily attributable to a $0.5
million decrease in personnel related expenses due to reduced
headcount and a $0.3 million decrease in outsourced clinical and
regulatory consulting services. These decreases were partially
offset by a $0.5 million increase in clinical trial expenses
related to the Company’s ongoing basket trial of GPS in combination
with pembrolizumab and a $0.1 million increase in licensing fees.
Research and development expenses for the six months ended June 30,
2019 were $3.2 million, as compared to $3.4 million for the same
period in 2018. The decrease of $0.2 million was primarily
attributable to a $0.8 million decrease in personnel related
expenses resulting from reduced headcount, partially offset by a
$0.3 million increase in clinical trial expenses for the GPS basket
trial and an increase of $0.3 million in licensing fees.
G&A Expense: General and
administrative expenses were $2.6 million for the second quarter of
2019, as compared to $4.9 million for the second quarter of 2018.
The $2.3 million decrease was primarily due to a $1.3 million
decrease in legal fees, a $0.4 million decrease in public company
costs, a $0.3 million decrease in personnel related expenses due to
reduced headcount and a $0.3 million decrease in other expenses.
General and administrative expenses for the first half of
2019 were $5.1 million, as compared to $8.8 million for the six
months ended June 30, 2018. The $3.7 million decrease during the
period was primarily related to a $1.8 million decrease in legal
fees, a $0.5 million decrease in public company costs, a $0.4
million decrease in accounting and audit fees, a $0.3 million
decrease in personnel related expenses due to reduced headcount, a
$0.3 million decrease in outsourced consulting fees and a $0.4
million decrease in other expenses.
Net Loss: Net loss attributable
to common stockholders was $4.1 million for the second quarter of
2019, or a basic and diluted loss per share attributable to common
stockholders of $0.13, as compared to a net loss attributable to
common stockholders of $8.5 million for the second quarter of 2018,
or a basic and diluted loss per share attributable to common
stockholders of $1.26. Net loss attributable to common stockholders
was $9.1 million for the six months ended June 30, 2019, or a basic
and diluted loss per share attributable to common stockholders of
$0.33, as compared to a net loss attributable to common
stockholders of $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.
Keytruda® and Herceptin® are registered
trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck
& Co., Inc., Kenilworth, N.J., USA, 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.
About SELLAS Life Sciences Group,
Inc.
SELLAS is a clinical-stage biopharmaceutical
company focused on 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.
SELLAS’ second product candidate, NPS, 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.
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 GPS and NPS, including the timing of clinical
results. 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 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
22, 2019 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
Investors RelationsSELLAS Life Sciences Group,
Inc. 917.438.4353info@sellaslife.com
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