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 March 31,
2019.
“Throughout 2019, as we have been progressing
the review of strategic alternatives, we also have been continuing
to advance our novel cancer immunotherapy clinical pipeline and are
excited to be presenting data on one of our clinical candidates,
nelipepimut-S (NPS), at the upcoming American Society of Clinical
Oncology (ASCO) Annual Meeting,” said Angelos Stergiou, MD, ScD
h.c., President and Chief Executive Officer of SELLAS.
American Society of Clinical Oncology
2019 Annual Meeting
Sellas will present immunologic response data
from the NPS/Trastuzumab Study will be presented at the upcoming
ASCO Annual Meeting being held May 31 – June 4, 2019 in Chicago,
IL. Details for the presentation are as follows:
- Title: Immunologic responses in
triple-negative breast cancer patients in a randomized phase IIb
trial of nelipepimut-S plus trastuzumab versus trastuzumab alone to
prevent recurrence
- Presenter: Jessica Campf, MD, San Antonio
Military Medical Center
- Abstract Number: 556
- Poster Session: “Breast Cancer –
Local/Regional/Adjuvant”
- Date and Time: June 2, 2019, 8:00 am – 11:00
am CDT
- Location: Hall A, McCormack Place, Chicago,
IL
First Quarter 2019 and Recent
Highlights
- Galinpeptimut-S (GPS) -- In February 2019, the Company
announced that Richard Maziarz, M.D., Medical Director of the Adult
Blood and Marrow Stem Cell Transplant & Cellular Therapy
Program at the Knight Cancer Institute and Professor of Medicine at
Oregon Health and Science University (OHSU), and Roisin
O'Cearbhaill, M.D., Assistant Attending Physician in Gynecologic
Medical Oncology Service at Memorial Sloan Kettering Cancer Center
(MSKCC), will serve as co-principal investigators of the Company’s
Phase 1/2 open-label, non-comparative, multicenter, multi-arm study
of GPS in combination with Merck’s anti-PD-1 therapy KEYTRUDA®
(pembrolizumab) in patients with selected WT1-positive advanced
cancers, including both hematologic malignancies and solid tumors.
The study is assessing the efficacy and safety of the combination,
with exploratory long-term follow-up for overall survival and
safety. -- In April 2019, the Company announced an
agreement with MSKCC to conduct an investigator-sponsored clinical
trial of GPS in combination with Bristol-Myers Squibb’s anti-PD-1
therapy, nivolumab, in patients with malignant pleural mesothelioma
(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.
- Nelipepimut-S (NPS) -- In February 2019, the Company
announced preliminary immune response data from an analysis of the
patterns of induction of NPS-specific T-cell responses over time in
a subgroup of patients with triple-negative breast cancer (TNBC)
from the prospective, randomized, single-blinded, controlled Phase
2b independent investigator-sponsored clinical study of the
combination of trastuzumab (Herceptin®) +/- NPS targeting HER2
low-expressing breast cancer patient cohorts (the NPS/Trastuzumab
Study). CD8+ cytotoxic T-lymphocytes (CTLs) from peripheral blood
samples from study patients with TNBC were measured using
specifically designed NPS-specific dextramers in a flow
cytometry-based assay in duplicate. In 64 evaluable TNBC patients
(39 in the NPS plus trastuzumab arm; 25 in the trastuzumab alone
arm) across a median of four time-points (including baseline), NPS
+ trastuzumab administration generated up to 3-fold higher
frequencies of NPS-specific CTLs compared to trastuzumab alone. CTL
frequencies were higher among non-recurrent patients compared with
those who recurred, on either arm. -- In March 2019,
SELLAS announced previously unreported disease free survival (DFS)
data from the NPS/Trastuzumab Study. In the 97-patient TNBC cohort,
the 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. In the intent-to-treat (ITT)
population (all HER2 low-expressing breast cancer patients; n=275),
and over the 24-month post-randomization follow-up period, the DFS
landmark rate was in favor of the combination arm (89.8%)
versus trastuzumab alone (83.8%).
- Corporate -- In February 2019, the Company announced
that it engaged Cantor Fitzgerald & Co. to act as its strategic
and financial advisor in conducting a review of strategic options.
This strategic review is ongoing and there can be no assurance that
this process will result in a transaction. -- In the
first quarter and early in the second quarter of 2019, the Company
received aggregate gross proceeds of $3.5 million from the exercise
of warrants from a holder pursuant to a Warrant Exercise Agreement
which reduced the exercise price of certain outstanding warrants
from $2.10 to $1.10 and provided for the issuance to the holder of
new warrants on a share-for-share basis in an amount equal to the
number of existing warrants that are cash exercised by the holder
prior to May 31, 2019.
First Quarter 2019 Financial
Results
R&D Expenses: Research and
development expenses were $1.9 million for the first quarter of
2019, as compared to $1.8 million for the first quarter of 2018.
The $0.1 million increase was primarily attributable to a $0.4
million increase in outsourced clinical and regulatory consulting
related to our ongoing discussions with the U.S. Food and Drug
Administration for further development of the combination of NPS
plus trastuzumab in TNBC and a $0.2 million increase in licensing
fees. These increases were partially offset by a $0.3 million
decrease in clinical expenses due to the completion of the Phase 2b
trial of NPS in combination with trastuzumab in 2018 and a $0.2
million decrease in personnel related expenses due to reduced
headcount.
G&A Expense: General and
administrative expenses were $2.5 million for the first quarter of
2019, as compared to $3.9 million for the first quarter of 2018.
The $1.4 million decrease was due to a $0.6 million decrease
in legal fees, a $0.2 million decrease in accounting and audit
fees, a $0.2 million decrease in outsourced consulting, a $0.2
million decrease in public company costs and a $0.2 million
decrease in other expenses. These decreases were driven by our
focus on reducing expenses as we explore a wide range of strategic
alternatives.
Net Loss: Net loss attributable
to common stockholders was $5.0 million for the first quarter of
2019, or a basic and diluted loss per share attributable to common
stockholders of $0.22, as compared to a net loss attributable to
common stockholders of $10.0 million for the first quarter of 2018,
or a basic and diluted loss per share attributable to common
stockholders of $1.67.
Cash Position: As of March 31,
2019, cash and cash equivalents totaled approximately $2.6 million.
Cash and cash equivalents as of March 31, 2018 totaled
approximately $5.4 million. Net cash used in operating activities
for the quarter was $5.0 million, compared to $5.4 million for the
quarter ended March 31, 2018. During the first quarter, SELLAS
received net proceeds of $2.2 million from the exercise of certain
warrants. SELLAS received an additional $1.1 million from the
exercise of warrants subsequent to March 31, 2019.
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 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 a Phase 3 clinical trial planned
(pending funding availability) for GPS in AML and is also studying
GPS in combination with pembrolizumab (Keytruda®) in multiple
indications. SELLAS has received Orphan Drug designations for GPS
from the FDA and the European Medicines Agency for AML, malignant
pleural mesothelioma (MPM), and multiple myeloma (MM); GPS has also
received Fast Track designation for AML, MPM and MM from the FDA.
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. NPS 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+, 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 to explore
strategic alternatives, the potential outcome and benefits of a
strategic transaction or a financing, the further development of
GPS and NPS, including the timing of clinical results, the
potential time to market for GPS and NPS, the potential results
from a clinical trial and interactions with the U.S. Food and Drug
Administration. 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 Company’s ability to identify
potential strategic and financial transactions and to complete any
transactions it pursues, whether SELLAS will be able to realize the
expected benefits from a strategic review or a strategic
transaction, immune-oncology product development and clinical
success thereof, the uncertainty of regulatory approval, the
uncertainty of finding potential partners for product candidate
development, 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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