SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the
“Company”), a late-stage clinical biopharmaceutical company focused
on developing novel cancer immunotherapies for a broad range of
indications, today reported its financial results for the full year
ended December 31, 2020 and provided a business update.
“Despite numerous challenges caused by the COVID-19 pandemic,
during 2020 SELLAS remained steadfast and focused on its core
mission to develop innovative cancer immunotherapies to prolong
patients’ lives. With this goal driving our efforts, the team
successfully signed an exclusive license agreement with 3D
Medicines to further develop and commercialize galinpepimut-S (GPS)
in Greater China, with potential to receive total payments under
the agreement of up to $202 million, including the $7.5 million
upfront license fee received at the end of 2020. This agreement
marks the first step in our commercialization strategy for GPS. We
look forward to progressing our GPS clinical program in 2021,
including the Phase 3 REGAL study of GPS in acute myeloid leukemia
(AML) patients which is currently underway in the United States and
Europe,” said Angelos Stergiou, MD, ScD. h.c., President and Chief
Executive Officer of SELLAS.
“The fourth quarter of 2020 brought a strong close to a
transformative year for SELLAS. Of significance, we successfully
strengthened our balance sheet through a registered direct
offering, the exercise of warrants and the upfront licensing fee
from our agreement with 3D Medicines, ending the year with cash and
cash equivalents of $35.3 million,” concluded Dr. Stergiou.
Pipeline Updates:
Galinpepimut-S (GPS)
- Following commencement of the Phase 3 REGAL study in AML
patients in early 2020, the Company began to initiate clinical
sites for the study in the United States and, later in 2020, in
Europe. As the global COVID-19 pandemic intensified, the Company
observed that clinical site initiations and patient enrollment, in
general, were delayed due to prioritization of hospital resources
towards the COVID-19 pandemic and as a result of the various
lockdowns, quarantines and other restrictions in the United States
and Europe. The Company took several steps to mitigate the effect
of these delays on the timeline for the REGAL study, including
increasing the expected number of clinical sites from 50 to up to
approximately 135, increasing the number of countries in which
sites were or will be initiated, and allocating additional
resources, including additional CROs and internal personnel, to the
REGAL study. Based upon the Company’s current assumptions,
including with respect to the continuing impact of COVID-19, the
Company anticipates that the planned interim safety and futility
analysis for the REGAL study is likely to occur in the first half
of 2022 provided that the assumptions regarding COVID-19, including
the duration thereof and the availability and uptake of COVID-19
vaccines, especially in Europe, remain unchanged.
- In late 2020, SELLAS manufactured the first of three
registration batches of GPS which will be required for regulatory
approval filings assuming positive data from the REGAL study. This
additional batch will be used in the GPS clinical programs and for
clinical supply required to be provided to 3D Medicines pursuant to
the license agreement with 3D Medicines.
- In the second half of 2020, the Company received approval from
each of the French and German regulatory authorities to
advance the REGAL study in those countries. Approvals from
additional European health authorities are expected in early 2021
which will allow the Company to expand AML patient enrollment for
the REGAL study in Europe.
- In December 2020, SELLAS announced initial data from two early
stage clinical studies of GPS in combination with checkpoint
inhibitor therapies. Early data from the Company’s Phase 1/2 basket
study of GPS in combination with Merck’s pembrolizumab in 2nd or
3rd line WT1(+) relapsed or refractory metastatic ovarian cancer
patients showed a disease control rate of 87.5% at a median
follow-up of 9.4 weeks and 100% progression free survival rate at 6
weeks post-therapy initiation in eight evaluable patients. In the
Phase 1 investigator sponsored study of GPS in combination with
nivolumab in patients with relapsed/refractory malignant pleural
mesothelioma (MPM), early data showed a median progression-free
survival rate of at least 10 weeks in three evaluable patients. Any
prolongation of progression-free interval greater than 8 weeks in
primary refractory MPM would be considered clinically meaningful.
Further clinical and immunobiological data from both of these
studies are expected in the first half of 2021.
- In December 2020, the Company announced an exclusive license
agreement with 3D Medicines Inc., a China-based biopharmaceutical
company developing next-generation immuno-oncology drugs, for the
development and commercialization of GPS, as well as the Company’s
next generation heptavalent immunotherapeutic GPS+, across all
therapeutic and diagnostic uses in the Greater China territory
(mainland China, Hong Kong, Macau and Taiwan). The potential
licensing fees and milestone payments to SELLAS under the
agreement, including an upfront license fee of $7.5 million paid in
December 2020, but exclusive of potential future royalties, could
total $202 million.
- In February 2021, SELLAS triggered a milestone in the amount of
$1.0 million related to completion of a technology transfer plan
under its license agreement with 3D Medicines. The Company expects
to receive payment of this milestone by the end of the first
quarter of 2021.
Nelipepimut-S (NPS)
- In December 2020, SELLAS announced positive final data with up
to 6 months follow-up from an investigator-sponsored Phase 2
randomized trial (the VADIS study) of NPS in combination with
granulocyte-macrophage colony-stimulating factor (GM-CSF) in women
with ductal carcinoma in situ (DCIS) of the breast. Preliminary
data previously reported showed that treatment with even a single
dose of NPS was capable of newly inducing NPS-specific cytotoxic
T-lymphocytes (CTLs) in peripheral blood in DCIS patients. The
updated data, based on a 6-month follow-up, demonstrate that CD8+
T-cell responses persist long-term post-NPS treatment, with treated
patients retaining and modestly enhancing their antigen-specific
immune response. The relative change in NPS-CTL% mean values at 6
months post-vaccination was +1,300+450% for the NPS+GM-CSF group
vs. 250+150% in the GM-CSF alone group, which was highly
statistically significant in favor of the NPS+GM-CSF group:
p=0.000094.
- In January 2021, the data safety monitoring board recommended,
with respect to the ongoing investigator sponsored study of NPS
plus trastuzumab in high risk HER2 3+ breast cancer patients that,
given the small size of the study and in order to preserve the
statistical power of the study, the primary analysis of the study
be completed upon the completion of three years of follow-up on
every patient or until more events are collected. The Company
expects the primary analysis in this study to be completed by the
end of 2021.
- In February 2021, the subgroup analysis of the cohort of
patients with triple negative breast cancer (TNBC) from the Phase
2b investigator-sponsored study of NPS plus trastuzumab in HER2
low-expressing breast cancer patients was published in the
peer-reviewed journal Clinical Immunology. As previously reported,
the subset analysis identified significant improvement in 36-month
disease-free survival between NPS (n=55) and placebo (n=44) in
TNBC.
Corporate Highlights During and Subsequent to the Fourth
Quarter 2020:
- In December 2020, SELLAS closed a registered direct offering
receiving net proceeds of approximately $15.0 million, after
deducting placement agent fees and other estimated offering
expenses.
- In December 2020, the Company received a non-dilutive license
fee of $7.5 million from 3D Medicines, Inc. pursuant to the license
agreement discussed above.
- Between December 2020 and February 2021, the Company received
approximately $11.5 million in net proceeds from the exercise of
outstanding warrants.
Financial Results for the Full Year 2020:
Licensing revenue: Licensing revenue for the
year ended December 31, 2020 was $1.9 million which consists
entirely of the recognition of $1.9 million of revenue from the
$7.5 million upfront license fee received in 2020 from the
Company’s license agreement with 3D Medicines. The Company did not
record any licensing revenue for the year ended December 31,
2019.
R&D Expenses: Research and development
expenses for the year ended December 31, 2020 were $9.3 million, as
compared to $7.3 million for the year ended December 31, 2019. The
increase was primarily due to clinical trial expenses incurred in
connection with the initiation of the Phase 3 REGAL study in
2020.
G&A Expenses: General and administrative
expenses for the year ended December 31, 2020 were $9.6 million, as
compared to $9.9 million for the year December 31, 2019. The
decrease was primarily due to a reduction in legal fees and
personnel related expenses partially offset by an increase in
insurance premiums due to hardening insurance markets.
Net Loss: Net loss attributable to common
stockholders was $16.8 million for the year ended December 31,
2020, or a basic and diluted loss per share attributable to common
stockholders of $2.11, as compared to a net loss attributable to
common stockholders of $28.0 million for the year ended December
31, 2019, or a basic and diluted loss per share attributable to
common stockholders of $10.92.
Cash Position: As of December 31, 2020, cash
and cash equivalents totaled approximately $35.3 million. The
strengthened year-end balance sheet is a result of the proceeds
received in December 2020 from a registered direct offering,
warrant exercises and the upfront license fee from 3D
Medicines.
About SELLAS Life Sciences Group, Inc.SELLAS is
a late-stage clinical biopharmaceutical company focused on
developing novel cancer immunotherapeutics for a broad range of
indications. SELLAS’ lead product candidate, galinpepimut-S (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 both as a monotherapy and in combination to address a
broad spectrum of hematologic malignancies and solid tumor
indications. SELLAS’ second product candidate, nelipepimut-S (NPS),
is a HER2-directed cancer immunotherapy with potential to treat
patients with early-stage breast cancer with low to intermediate
HER2 expression, otherwise known as HER2 1+ or 2+, which includes
TNBC patients, following the standard of care.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Forward-Looking StatementsThis 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
clinical development of GPS for various cancer indications,
including AML, ovarian cancer and MPM, the potential for regulatory
approval and commercialization of GPS, statements related to the
clinical development of NPS for breast cancer, including DCIS.
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, 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 23, 2021 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.
For more information, please contact:
Investor ContactsValter Pinto / Allison
SossKCSA Strategic CommunicationsEmail: SELLAS@kcsa.com Phone:
914.907.2675 / 215.272.2707
Media ContactsCaitlin Kasunich / Raquel
ConaKCSA Strategic CommunicationsEmail: SELLAS@kcsa.com Phone:
212.896.1241 / 212.896.1276
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