Full Press Release Details
SELLAS Life Sciences Highlights 2020
Business and Clinical Progress and 2021 Milestones
3 REGAL Study of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) Patients Underway in United States and Europe -
- License Agreement with 3D Medicines for Development and Commercialization of GPS in China Initiates Commercialization Strategy
Sheet Significantly Strengthened in 2020 with Preliminary and Unaudited Cash and Cash Equivalents of $35.3 Million as of December
NEW YORK, January 14, 2021 (GLOBE NEWSWIRE)
-- 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 highlighted its
business and clinical progress in 2020 and expected 2021 milestones.
"2020 was a transformative year for
SELLAS as we commenced the pivotal Phase 3 REGAL study of GPS in patients with AML who have achieved complete remission after second-line
anti-leukemic therapy (CR2) in the United States and Europe and also announced important clinical data in the same patient cohort
from our completed Phase 2 study showing a median overall survival of 21 months vs. 5.4 months in favor of patients who received
GPS, with a p-value of 0.02. We are also intrigued by the recently announced initial data from two studies of GPS in combination
with checkpoint inhibitors in ovarian and malignant pleural mesothelioma indications, and we look forward to providing further
data from these studies in the first half of 2021. We were also pleased to present last month at the 2020 San Antonio Breast Cancer
Symposium positive final data with up to 6 months follow-up from the randomized Phase
2 trial (the VADIS study) of nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF)
in women with ductal carcinoma in-situ of the breast showing immune stimulation augmented by +1,300% at 6-months post-NPS treatment
and a statistically significant difference of duration of immune response of NPS vs. control with a p-value of 0.000094,"
stated Angelos Stergiou, MD, ScD h.c, President and Chief Executive Officer of SELLAS.
"Additionally, we began preparations
for the commercialization of GPS, assuming we achieve positive data from the REGAL study, with a collaboration with 3D Medicines
Inc. for the development and commercialization of GPS in Greater China which we announced at the end of 2020. This licensing transaction
with 3D Medicines for GPS has been ranked by PharmaCube, a leading Chinese database, as one of the top ten life sciences licensing
transactions in China in 2020 in terms of the total financial consideration," commented Dr. Stergiou.
"Importantly, we strengthened our
balance sheet in 2020 with gross proceeds of approximately $47.9 million from the sale of securities, exercise of warrants, and
the upfront payment from 3D Medicines and we ended the year with approximately $35.3 million in cash and cash equivalents. The
proceeds from these transactions will significantly support the GPS clinical programs," added Dr. Stergiou.
2020 Clinical Highlights and 2021
Galinpepimut-S (GPS)
The Company's preliminary and unaudited
cash and cash equivalents as of December 31, 2020 was approximately $35.3 million. The estimated cash and cash equivalents as of
December 31, 2020 are preliminary and may change, are based on information available to management as of the date of this press
release, and are subject to completion by management of the financial statements as of and for the year ended December 31, 2020.
There can be no assurance that the cash and cash equivalents as of December 31, 2020 will not differ from these estimates. Complete
annual results will be included in the Company's Annual Report on Form 10-K for the year ended December 31, 2020.
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.
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. Opdivo is
a registered trademark of Bristol Myers Squibb, and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated
with and does not endorse SELLAS or its products.
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 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 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.
SELLAS Life Sciences Group, Inc.