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 quarter
ended March 31, 2021 and provided a business update.
“Under our exclusive license agreement with 3D Medicines for the
development and commercialization of galinpepimut-S (GPS) in
Greater China, we advanced the technology transfer to 3D Medicines
during the first quarter of 2021. In February, our progress
triggered a milestone payment of $1.0 million. This achieved
milestone is the first of milestone payments that have the
potential to total $194.5 million over the life of the agreement.
In addition to the $1.0 million payment, we further strengthened
our balance sheet during the first quarter with approximately $3.0
million in net proceeds from warrant exercises,” said Angelos
Stergiou, MD, ScD. h.c., President and Chief Executive Officer of
SELLAS. “During the quarter, we continued to progress our GPS
clinical program with the activation of additional clinical sites
in the United States, and also preparations for opening clinical
sites and enrolling patients in European countries, for our Phase 3
REGAL study of GPS in patients with acute myeloid leukemia (AML).
Screening and enrollment of patients for the REGAL study is ongoing
in the United States.”
Pipeline Updates:
Galinpepimut-S (GPS)
- During the first quarter of 2021, SELLAS triggered and received
a milestone payment in the amount of $1.0 million related to the
completion of a technology transfer plan under its license
agreement with 3D Medicines.
- In April 2021, the Company received National Ethics Committee
approval in Greece for the Phase 3 REGAL study in patients with
AML. The Company expects to activate sites and begin enrolling
patients in France, Germany and Greece by the end of the second
quarter of 2021.
Nelipepimut-S (NPS)
- In January 2021, the data safety monitoring board for the
ongoing investigator sponsored study of NPS plus trastuzumab in
high risk HER2 3+ breast cancer patients recommended 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 for the First Quarter
2021:
- The Company received approximately $3.0 million in net proceeds
from the exercise of common stock warrants.
Financial Results for the First Quarter
2021:
Licensing revenue: During the first quarter of
2021 the Company recorded $5.7 million of licensing revenue which
consists of the recognition of revenue from the upfront license fee
received from 3D Medicines in 2020 and the milestone payment
received in the first quarter of 2021 from the achievement of a
milestone under the Company’s license agreement with 3D Medicines.
The Company did not record any licensing revenue for the first
quarter of 2020.
R&D Expenses: Research and development
expenses for the first quarter of 2021 were $4.3 million, as
compared to $1.9 million for the first quarter of 2020. The
increase was primarily due to a ramp up of the manufacture of
clinical trial materials and registration batches of GPS, a
technology transfer to a new contract manufacturer, and clinical
drug supply purchase costs in the European Union in preparation for
opening sites and enrolling patients in European Union
countries.
G&A Expenses: General and administrative
expenses for the first quarter of 2021 were $3.6 million, as
compared to $2.2 million for the first quarter of 2020. The
increase was primarily due to amortization expense associated with
the capitalized contract acquisition costs of the 3D Medicines
license agreement as well as an increase in legal fees.
Net Loss: Net loss attributable to common
stockholders was $2.4 million for the first quarter of 2021, or a
basic and diluted loss per share attributable to common
stockholders of $0.16, as compared to a net loss attributable to
common stockholders of $4.2 million for the first quarter of 2020,
or a basic and diluted loss per share attributable to common
stockholders of $0.66.
Cash Position: As of March 31, 2021, cash and
cash equivalents totaled approximately $28 million.
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, 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, 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, the
potential for regulatory approval and commercialization of GPS, the
potential for additional milestone payments under license
agreement, and the clinical development of NPS for breast cancer.
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
SELLAS LIFE SCIENCES GROUP,
INC.CONSOLIDATED STATEMENTS OF
OPERATIONS(Amounts in thousands, except share and
per share data)(Unaudited)
|
Three Months Ended March 31, |
|
2021 |
|
2020 |
Licensing revenue |
$ |
5,700 |
|
|
|
$ |
— |
|
|
Operating expenses: |
|
|
|
Cost of licensing revenue |
100 |
|
|
|
— |
|
|
Research and development |
4,284 |
|
|
|
1,864 |
|
|
General and administrative |
3,561 |
|
|
|
2,200 |
|
|
Total operating expenses |
7,945 |
|
|
|
4,064 |
|
|
Operating loss |
(2,245 |
) |
|
|
(4,064 |
) |
|
Non-operating income (expense),
net: |
|
|
|
Change in fair value of warrant liability |
(31 |
) |
|
|
35 |
|
|
Change in fair value of contingent consideration |
(129 |
) |
|
|
(138 |
) |
|
Interest income, net |
2 |
|
|
|
24 |
|
|
Total non-operating income (expense), net |
(158 |
) |
|
|
(79 |
) |
|
Net loss |
(2,403 |
) |
|
|
(4,143 |
) |
|
Deemed dividend arising from
warrant modifications |
— |
|
|
|
(78 |
) |
|
Net loss attributable to common
stockholders |
$ |
(2,403 |
) |
|
|
$ |
(4,221 |
) |
|
|
|
|
|
Per share information: |
|
|
|
Net loss per common share
attributable to common stockholders, basic and diluted |
$ |
(0.16 |
) |
|
|
$ |
(0.66 |
) |
|
Weighted-average common shares
outstanding, basic and diluted |
14,877,317 |
|
|
|
6,374,979 |
|
|
SELLAS LIFE SCIENCES GROUP,
INC.CONSOLIDATED BALANCE
SHEETS(Amounts in thousands, except share and per
share data)(Unaudited)
|
March 31, 2021 |
|
December 31, 2020 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
28,033 |
|
|
|
$ |
35,302 |
|
|
Restricted cash and cash equivalents |
100 |
|
|
|
100 |
|
|
Contract asset |
282 |
|
|
|
1,128 |
|
|
Prepaid expenses and other current assets |
3,016 |
|
|
|
395 |
|
|
Total current assets |
31,431 |
|
|
|
36,925 |
|
|
Operating lease right-of-use
asset |
854 |
|
|
|
896 |
|
|
In-process research and
development |
5,700 |
|
|
|
5,700 |
|
|
Goodwill |
1,914 |
|
|
|
1,914 |
|
|
Deposits and other assets |
676 |
|
|
|
614 |
|
|
Total assets |
$ |
40,575 |
|
|
|
$ |
46,049 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,350 |
|
|
|
$ |
4,657 |
|
|
Accrued expense and other current liabilities |
2,547 |
|
|
|
1,913 |
|
|
Operating lease liability |
174 |
|
|
|
166 |
|
|
Deferred revenue |
900 |
|
|
|
5,600 |
|
|
Total current liabilities |
5,971 |
|
|
|
12,336 |
|
|
Operating lease liability,
non-current |
775 |
|
|
|
825 |
|
|
Deferred tax liability |
239 |
|
|
|
239 |
|
|
Warrant liability |
86 |
|
|
|
55 |
|
|
Contingent consideration |
4,762 |
|
|
|
4,633 |
|
|
Total liabilities |
11,833 |
|
|
|
18,088 |
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.0001 par value; 5,000,000 shares
authorized; Series A convertible preferred stock, 17,500 shares
designated; no shares issued and outstanding at March 31, 2021 and
December 31, 2020 |
— |
|
|
|
— |
|
|
Common stock, $0.0001 par value; 350,000,000 shares
authorized, 15,084,754 and 14,254,554 shares issued and
outstanding at March 31, 2021 and December 31, 2020,
respectively. |
2 |
|
|
|
1 |
|
|
Additional paid-in capital |
149,047 |
|
|
|
145,864 |
|
|
Accumulated deficit |
(120,307 |
) |
|
|
(117,904 |
) |
|
Total stockholders’ equity |
28,742 |
|
|
|
27,961 |
|
|
Total liabilities and stockholders’ equity |
$ |
40,575 |
|
|
|
$ |
46,049 |
|
|
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