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 corporate update and
reported financial results for the quarter ended September 30,
2019.
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 (the
REGAL study) is on track to initiate by year end.
Further, the Company announced that follow-up
data from its Phase 1 clinical trial of GPS in combination with
nivolumab to treat Wilms Tumor 1 (WT1) positive patients with
ovarian cancer in second- or third-line remission continues to
support the development of GPS in combination with PD-1 inhibitors.
Topline data from this study at 10 months had been presented at the
June 2018 meeting of the American Society of Clinical Oncology.
These follow-up data now show that three of the 11 patients
enrolled in the study have continued to show no signs of disease
progression. The mean progression free survival (PFS) for these
three patients is 35.4 months from the initiation of salvage
chemotherapy or mean PFS of 30.1 months from the first
administration of GPS plus nivolumab. Based on this follow-up
information, the estimated two-year PFS rate for this study is now
27.3% for the intent-to-treat (ITT) patients (n=11) and
approximately 30% for patients who received greater than two doses
of GPS and nivolumab (n=10), as compared to a historical 3% to 10%
PFS rate for patients receiving only salvage chemotherapy. No
new serious adverse events were noted during the longer follow-up
period.
“Given these promising and clinically
significant follow-up data from our GPS in combination with a PD-1
inhibitor Phase 1 clinical trial, we are encouraged with regard to
the possible clinical activity of this combination approach and we
are looking forward to the initial clinical data from our Phase 1/2
basket study of GPS in combination with KEYTRUDA® (pembrolizumab)
in the second half of 2020 in a comparable ovarian cancer patient
population,” said Angelos Stergiou, MD, ScD h.c., President and
Chief Executive Officer of SELLAS. “We are also excited to initiate
our Phase 3 registrational study of GPS in patients with AML by
year end. We look forward to continued progress in our
clinical programs, and to discussing our GPS program in more detail
with key opinion leaders during our R&D Investor Event/KOL
Symposium to be held tomorrow, November 15, 2019. “
Recent Pipeline Highlights
• Galinpepimut-S (GPS) Program
- SELLAS expects that initial
clinical sites for its Phase 3 AML registrational study (the REGAL
study) will be activated by the end of 2019. This randomized,
open-label study will compare 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. Interim data from this study
is expected by the end of 2021. The Company entered into a Master
Services Agreement with Worldwide Clinical Trials Limited in August
2019 and in October 2019 entered into a work order for the Phase 3
AML clinical trial.
- 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 two initial indications being
studied in this basket study are ovarian cancer (second or third
line) and colorectal cancer (third or fourth 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 second half of
2020.
• 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 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. 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 September 2019, SELLAS submitted
to the U.S. Food and Drug Administration (FDA) a supplemental
regulatory package with additional information on the optimal
regulatory pathway for NPS in patients with triple negative breast
cancer (TNBC).
Recent Corporate Highlights
- On November 7, 2019, SELLAS
effected a 1-for-50 reverse split. Trading on a post-split basis
commenced on November 8, 2019. The Company’s stockholders had
previously approved a reverse split in the range of 1-for-20 to
1-for-60. The reverse stock split is intended to increase the per
share trading price of the Company’s common stock to satisfy the
$1.00 minimum bid price requirement for continued listing on The
Nasdaq Capital Market.
- On October 29, 2019, the Company
entered into an Equity Distribution Agreement with Maxim Group LLC,
as sales agent, in connection with an “at the market offering”
under which the Company from time to time may offer and sell shares
of its common stock, having an aggregate offering price of up to
$5,000,000. Shares sold under the Equity Distribution Agreement
will be offered and sold pursuant to the Company’s previously filed
and effective Registration Statement on Form S-3 and a prospectus
supplement and accompanying base prospectus that the Company filed
with the Securities and Exchange Commission. The Company intends to
use the net proceeds from the offering for working capital and
other general purposes, including the continued development of its
product candidates, including clinical trial activities.
R&D Investor Day
The Company will host its first R&D Investor
Day in New York, NY tomorrow, 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 global principal
investigator of the Phase 3 AML REGAL clinical
trial.
The event will be accessible via webcast on the
SELLAS website at www.sellaslifesciences.com. For more
information, please contact Will O’Connor, at
ir@sellaslife.com or 212.362.1600.
Third Quarter 2019 Financial
Results
Cash Position: As of September
30, 2019, cash and cash equivalents totaled approximately $9.1
million. Subsequent to the end of the third quarter, the Company
has issued and sold approximately $1.9 million of Common Stock
pursuant to the Equity Distribution Agreement.
R&D Expenses: Research and
development expenses were $1.8 million for the third quarter of
2019, as compared to $1.7 million for the third quarter of 2018.
The $0.1 million increase was primarily attributable to a $0.2
million increase in manufacturing related expenses for GPS and a
$0.1 million increase in clinical trial expenses due to the
Company’s basket trial of GPS in combination with pembrolizumab and
start-up costs for the GPS AML Phase 3 study, partially offset by a
$0.1 million decrease in personnel related expenses due to reduced
headcount. Research and development expenses for the nine months
ended September 30, 2019 were $5.0 million, as compared to $5.1
million for the same period in 2018. The decrease of $0.1 million
was primarily attributable to a $0.9 million decrease in personnel
related expenses resulting from reduced headcount and a $0.1
million decrease in other research and development expenses,
partially offset by a $0.5 million increase in manufacturing
related expense for GPS, a $0.3 million increase in licensing fees,
and a $0.1 increase in clinical trial expenses for the GPS basket
trial and start-up costs for the GPS AML Phase 3 study.
G&A Expense: General and
administrative expenses were $2.4 million for the third quarter of
2019, as compared to $1.3 million for the third quarter of 2018.
The $1.1 million increase was due to a $1.2 million increase in
legal fees and a $0.1 million increase in public company costs,
partially offset by $0.2 million decrease in personnel related
expenses due to reduced headcount. General and administrative
expenses for the nine months ended September 30, 2019 were $7.5
million, as compared to $10.1 million for the nine months ended
September 30, 2018. The $2.6 million decrease during the period was
primarily related to a $0.6 million decrease in legal fees, a $0.5
million decrease in personnel related expenses due to reduced
headcount, 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 outsourced consulting fees and a $0.3 million decrease
in other expenses.
Net Loss: Net loss attributable
to common stockholders was $11.5 million for the third quarter of
2019, or a basic and diluted loss per share attributable to common
stockholders of $2.68, as compared to a net loss attributable to
common stockholders of $9.4 million for the third quarter of 2018,
or a basic and diluted loss per share attributable to common
stockholders of $26.75. Net loss attributable to common
stockholders was $20.5 million for the nine months ended September
30, 2019, or a basic and diluted loss per share attributable to
common stockholders of $11.37, as compared to a net loss
attributable to common stockholders of $27.9 million for the nine
months ended September 30, 2018, or a basic and diluted loss per
share attributable to common stockholders of $137.43.
Keytruda® is a registered trademark of Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Kenilworth, N.J., USA, and is not a trademark of SELLAS. The
manufacturer of this brand is not affiliated with and does not
endorse SELLAS or its products.
About SELLAS Life Sciences Group,
Inc.
SELLAS is a late stage clinical
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 and regulatory plans for 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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