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 business update and
reported financial results for the quarter ended September 30,
2020.
“In the third quarter, we announced an important
milestone for our Phase 3 REGAL study of galinpepimut-S (GPS) in
acute myeloid leukemia (AML) when we received approval from the
French regulatory authorities for our Investigational Medicinal
Product Dossier (IMPD), which allows SELLAS to commence patient
enrollment for the REGAL study in France,” said Angelos M.
Stergiou, MD, ScD h.c., President and Chief Executive Officer of
SELLAS. “We also strengthened our balance sheet during the quarter
with a $9.2 million private placement of shares and warrants priced
at-the-market. We are using the proceeds from the financing to
continue to progress our ongoing GPS studies, as the Company moves
closer to the multiple data readouts that are expected over the
next 18 months, including the initial data review of our
mesothelioma study by year end.”
Pipeline Highlights
- Galinpepimut-S (GPS)
- In September
2020, SELLAS announced the approval of its Investigational
Medicinal Product Dossier (IMPD) from Agence Nationale de Sécurité
du Médicament et des Produits de Santé (ANSM), the French
regulatory authority, to advance the enrollment in France for the
Phase 3 REGAL study of GPS in patients with AML who have achieved
complete remission after second-line anti-leukemic therapy
(CR2).
- Nelipepimut-S
- Finalized data
from the National Cancer Institute-sponsored Phase 2 randomized
trial of nelipepimut-S (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 VADIS study will be presented in a
Spotlight Poster-Discussion Session, PD11-09, at the 2020 San
Antonio Breast Cancer Symposium, December 8-12,
2020: https://www.sabcs.org/Program/Spotlight-Sessions/Spotlight-Poster-Discussion-11
Session Date – Time: Friday, December 11, 2020: 2:15 pm – 3:30
pm
Corporate Highlights
- In August 2020,
SELLAS received gross proceeds of approximately $9.2 million from a
private placement financing with certain institutional and
accredited investors.
Third Quarter 2020 Financial
Results
R&D Expenses: Research and
development expenses were $2.4 million for the third quarter of
2020, as compared to $1.8 million for the third quarter of 2019.
Research and development expenses for the nine months ended
September 30, 2020 were $6.5 million, as compared to $5.0 million
for the same period in 2019. The increases in research and
development expenses during the third quarter and the nine months
ended September 30, 2020 compared to the same periods in 2019 were
primarily due to clinical trial expenses incurred for the REGAL
study commencing in 2020.
G&A Expense: General and
administrative expenses were $2.1 million for the third quarter of
2020, as compared to $2.4 million for the third quarter of 2019.
General and administrative expenses for the nine months ended
September 30, 2020 were $6.3 million, as compared to $7.5 million
for the same period in 2019. The decreases during the third quarter
and the nine months ended September 30, 2020 compared to the same
periods in 2019 were 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 $4.5 million for the third quarter of
2020, or a basic and diluted loss per share attributable to common
stockholders of $0.53, as compared to a net loss attributable to
common stockholders of $11.5 million for the third quarter of 2019,
or a basic and diluted loss per share attributable to common
stockholders of $2.68. Net loss attributable to common stockholders
was $13.1 million for the nine months ended September 30, 2020, or
a basic and diluted loss per share attributable to common
stockholders of $1.83, as compared to a net loss attributable to
common stockholders of $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.
Cash Position: As of September
30, 2020, cash and cash equivalents totaled approximately $8.2
million.
Impact of COVID-19
During the third quarter of 2020, the Company
continued to initiate additional sites for its GPS clinical program
as planned. However, the Company has observed that clinical site
initiations and patient enrollment may be delayed due to
prioritization of hospital resources towards the COVID-19 pandemic.
Clinicians and patients may not be able to comply with clinical
trial protocols if quarantines impede patient movement or interrupt
the operations at sites. Additionally, several European Union
countries in which the Company plans to initiate clinical sites,
including Germany, France, and Italy, have imposed new "lockdown"
restrictions in response to the recent surge in coronavirus cases
throughout the European Union and coronavirus cases in the United
States continue to accelerate. Because of the uncertainty as to the
impact that the surge in coronavirus cases could have on the
operations of newly initiated sites in the United States and the
European Union, which could then impact the projected timelines for
the REGAL study, the Company now believes that the planned interim
safety and futility analysis for the REGAL study may occur by the
end of 2021 or early 2022.
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 triple negative
breast cancer 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 and the potential for GPS as a drug development
candidate. 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.
Investor ContactsAdam HoldsworthPCG
Advisory646-862-4607adamh@pcgadvisory.com
Investor RelationsSELLAS Life Sciences Group,
Inc.917-438-4353info@sellaslife.com
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