Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics, announced today
financial results for the quarter ended December 31, 2018. The
Company also reviewed recent milestones:
ELZONRIS™ (tagraxofusp) – US Approval and Commercial
Launch
- ELZONRIS was FDA-approved on December 21, 2018 for the
treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN)
in adults and in pediatric patients, two years and older.
- ELZONRIS has been commercially available in the U.S. since the
end of January 2019, and patients are currently being treated with
ELZONRIS in the commercial setting.
- A Marketing Authorization Application (MAA) for ELZONRIS
seeking marketing approval in Europe was submitted to, and
subsequently validated by, the European Medicines Agency (EMA) in
January 2019. The MAA has been granted accelerated assessment and
is currently under review.
ELZONRIS – Market Expansion Efforts
- ELZONRIS is being evaluated in clinical trials in additional
indications, including chronic myelomonocytic leukemia (CMML),
myelofibrosis (MF), and acute myeloid leukemia (AML).
- Based on the clinical results observed in CMML and MF thus far,
we are evaluating potential registrational pathways in these
indications. For CMML, we intend to discuss registration-directed
plans with the FDA mid-year.
- We are also working towards expansion opportunities within the
BPDCN universe, including maintenance therapy after stem cell
transplant.
- In parallel, we plan to expand our clinical efforts later this
year and next into subsets of AML patients enriched for CD123+
expression.
- We expect to provide periodic updates on these initiatives
throughout this year and next at scientific conferences.
ASH Conference
- In December 2018, ELZONRIS data were selected for four
presentations at the 2018 American Society of Hematology (ASH)
conference. Presentations included results of the BPDCN pivotal
trial, delivered via oral presentation, and updated clinical trial
data in patients with CMML and MF.
- Additionally, we had an active clinical, medical affairs and
pre-commercial presence at ASH focused on BPDCN disease
awareness.
SL-801
- In October 2018, data from the ongoing Phase 1 trial of SL-801
in patients with advanced solid tumors were presented at the
European Society of Medical Oncology (ESMO) Annual Congress 2018.
We expect to provide further updates at upcoming conferences.
SL-701
- In November 2018, data from the Phase 2 trial of SL-701 in
patients with second-line glioblastoma (GBM) were delivered via
oral presentation at the 23rd Annual Meeting of the Society of
Neuro-Oncology (SNO). We expect to provide further updates on this
program later this year.
SL-901
- SL-901 is a novel kinase inhibitor that was evaluated in an
abbreviated Phase 1 trial of solid tumor patients in Europe.
Neither a dose limiting toxicity nor maximum tolerated dose was
identified, and there was one partial response (PR) in a patient
with advanced non-small cell lung cancer. We plan to re-initiate a
Phase 1 study by early 2020.
SL-1001
- In March 2019, we announced the in-licensing of SL-1001, a
novel, selective RET kinase inhibitor that demonstrated potent
preclinical in vitro and in vivo activity. We expect to begin
IND-enabling studies this year, with a Phase 1 clinical trial
targeted for 2020.
Robert Francomano, SVP and Global Head of Commercial, commented,
“2018 was a transformational year for Stemline as we invested in
building out a focused, world class, commercial organization ahead
of the FDA approval of ELZONRIS. We are excited to bring this
important new treatment to patients, and our highly talented team
is in the field, excited, engaged, and poised for success in
2019.”
Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented,
“We have built a solid foundation for growth in 2019 and beyond,
driven by the launch of ELZONRIS in BPDCN. ELZONRIS is the first
drug ever approved for BPDCN and brings to patients with BPDCN a
new treatment option and hope. In parallel, our team is working
diligently with the EMA in an effort to make ELZONRIS potentially
available to patients in Europe. We continue to aggressively pursue
market expansion efforts with ELZONRIS, while also building out our
overall pipeline, with the goal of improving the lives of patients
with cancer.”
Fourth Quarter 2018 Financial Results
ReviewStemline ended the fourth quarter of 2018 with $60.1
million in cash, cash equivalents and investments, as compared to
$78.5 million as of September 30, 2018, which reflects cash
expenditures of $18.4 million for the quarter. Subsequent to
year-end 2018, Stemline completed a follow-on public offering
during January 2019 raising $86.1 million in net cash proceeds
bringing total cash, cash equivalents and investments to $125.2
million as of March 15, 2019.
For the fourth quarter of 2018, Stemline had a net loss of $26.6
million, or $0.92 per share, compared with a net loss of $21.7
million, or $0.93 per share, for the same period in 2017.
Research and development expenses were $12.1 million for the
fourth quarter of 2018, which reflects a decrease of $4.6 million
compared with $16.7 million for the fourth quarter of 2017. The
higher costs in 2017 were primarily due to manufacturing and
regulatory expenses in support of our BLA filing for ELZONRIS.
General and administrative expenses were $14.9 million for the
fourth quarter of 2018, which reflects an increase of $9.7 million
compared with $5.2 million for the fourth quarter of 2017. The
increase in costs were primarily attributable to pre-launch
expenses in support of the commercialization of ELZONRIS and
compensation costs related to an increase in headcount to support
the commercial launch.
About BPDCN BPDCN is an aggressive hematologic
malignancy with historically poor outcomes and an area of unmet
medical need. BPDCN typically presents in the bone marrow and/or
skin and may also involve lymph nodes and viscera. The BPDCN cell
of origin is the plasmacytoid dendritic cell (pDC) precursor. The
diagnosis of BPDCN is based on the immunophenotypic diagnostic
triad of CD123, CD4, and CD56, and other markers. For more
information, please visit the BPDCN disease awareness website at
www.bpdcninfo.com.
About ELZONRIS™ ELZONRIS (tagraxofusp), a
CD123-directed cytotoxin, was approved by the Food and Drug
Administration (FDA) on December 21, 2018 for the treatment of
adult and pediatric patients, two years and older, with blastic
plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing
information in the U.S., visit www.ELZONRIS.com. In November 2018,
the European Medicines Agency (EMA) granted ELZONRIS accelerated
assessment to the marketing authorization application (MAA), which
was submitted to, and validated by, the EMA in January 2019.
ELZONRIS is also being evaluated in additional clinical trials in
other indications including chronic myelomonocytic leukemia (CMML),
myelofibrosis (MF) and acute myeloid leukemia (AML).
About Stemline Therapeutics Stemline
Therapeutics, Inc. is a biopharmaceutical company focused on the
development and commercialization of novel oncology therapeutics.
In December 2018, the FDA approved ELZONRIS, a targeted therapy
directed to CD123, for the treatment of adult and pediatric
patients, two years or older, with blastic plasmacytoid dendritic
cell neoplasm (BPDCN). In November 2018, the European Medicines
Agency (EMA) granted accelerated assessment to the marketing
authorization application (MAA) of ELZONRIS for the treatment of
patients with BPDCN, which was submitted to, and validated by, the
EMA in January 2019. ELZONRIS is also being evaluated in clinical
trials in additional indications including chronic myelomonocytic
leukemia (CMML), myelofibrosis (MF) and acute myeloid leukemia
(AML). Additional pipeline candidates include: SL-701
(immunotherapeutic; Phase 2 in glioblastoma patients completed),
SL-801 (XPO1 inhibitor; Phase 1 in advanced solid tumor patients
ongoing), SL-901 (novel kinase inhibitor; prior abbreviated
European Phase 1, IND-enabling studies ongoing), and SL-1001 (novel
RET kinase inhibitor, IND-enabling studies pending).
Forward-Looking StatementsSome of the
statements included in this press release may be forward-looking
statements that involve a number of risks and uncertainties. For
those statements, we claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995. The factors that could cause our
actual results to differ materially include: the success of our MAA
submission to the EMA; the success and timing of our clinical
trials and preclinical studies for our product candidates,
including site initiation, institutional review board approval,
scientific review committee approval, patient accrual, safety,
tolerability and efficacy data observed, and input from regulatory
authorities including the risk that the FDA, EMA, or other ex-U.S.
national drug authority ultimately does not agree with our data,
find our data supportive of approval, or approve any of our product
candidates; the possibility that results of clinical trials are not
predictive of safety and efficacy results of our product candidates
in broader patient populations or of our products if approved; our
plans to develop and commercialize our product candidates,
including, but not limited to delays in arranging satisfactory
manufacturing capabilities and establishing commercial
infrastructure for ELZONRIS; product efficacy or safety concerns
resulting in product recalls or regulatory action; the risk that
estimates regarding the number of patients with the diseases that
our products and product candidates may treat are inaccurate;
inadequate market penetration of our products; our products not
gaining acceptance among patients (and providers or third party
payers) for certain indications (due to cost or otherwise); the
risk that third party payors (including governmental agencies) will
not reimburse for the use of ELZONRIS at acceptable rates or at
all; the company’s ability to produce, maintain or increase sales
of ELZONRIS; the company’s ability to develop and/or commercialize
ELZONRIS; the adequacy of our pharmacovigilance and drug safety
reporting processes; our available cash and investments; our
ability to obtain and maintain intellectual property protection for
our products and product candidates; delays, interruptions, or
failures in the manufacture and supply of our products and product
candidates; the performance of third-party businesses, including,
but not limited to, manufacturers, clinical research organizations,
clinical trial sponsors and clinical trial investigators; and other
risk factors identified from time to time in our reports filed with
the SEC. Any forward-looking statements set forth in this press
release speak only as of the date of this press release. We do not
intend to update any of these forward-looking statements to reflect
events or circumstances that occur after the date hereof.
Contact: Investor RelationsStemline
Therapeutics, Inc.750 Lexington AvenueEleventh FloorNew York, NY
10022Tel:
646-502-2307Email: investorrelations@stemline.com
Table 1. Stemline Therapeutics, Inc. -
Balance Sheets
|
|
December 31, 2018 |
|
December 31, 2017 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
9,443,667 |
|
$ |
4,795,098 |
|
Short-term investments |
|
50,662,189 |
|
46,924,612 |
|
Prepaid
expenses and other current assets |
|
2,952,996 |
|
469,067 |
|
Total
current assets |
|
63,058,852 |
|
52,188,777 |
|
Property and equipment,
net |
|
222,413 |
|
136,672 |
|
Long-term
investments |
|
— |
|
14,468,414 |
|
Other Assets |
|
212,305 |
|
212,305 |
|
|
|
|
|
|
|
Total
assets |
|
$ |
63,493,570 |
|
$ |
67,006,168 |
|
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
21,153,062 |
|
$ |
19,742,087 |
|
Other
current liabilities |
|
|
65,862 |
|
|
96,826 |
|
Total
current liabilities |
|
21,218,924 |
|
19,838,913 |
|
Other liabilities |
|
72,591 |
|
96,826 |
|
Total
liabilities |
|
21,291,515 |
|
19,935,739 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
Preferred
stock $0.0001 par value, 5,000,000 shares authorized, none issued
and outstanding at December 31, 2018 and 2017 |
|
— |
|
— |
|
Common
stock $0.0001 par value, 53,750,000 shares authorized at December
31, 2018 and December 31, 2017. 31,943,186 shares issued and
outstanding at December 31, 2018 and 25,313,595 shares issued and
outstanding at December 31, 2017 |
|
3,194 |
|
2,531 |
|
Additional paid-in capital |
|
331,343,484 |
|
251,489,546 |
|
Accumulated other comprehensive loss |
|
(56,559 |
) |
(145,958 |
) |
Accumulated deficit |
|
(289,088,064 |
) |
(204,275,690 |
) |
Total
stockholders’ equity |
|
42,202,055 |
|
47,070,429 |
|
|
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
63,493,570 |
|
$ |
67,006,168 |
|
|
|
|
|
|
|
|
|
Table 2. Stemline Therapeutics, Inc. - Statements of
Operations
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
Income: |
|
|
|
|
|
|
|
|
Grant income |
$ |
— |
|
$ |
— |
|
$ |
500,000 |
|
$ |
898,199 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
12,074,872 |
|
|
16,725,380 |
|
|
47,725,019 |
|
|
50,242,386 |
|
General and
administrative |
|
14,853,116 |
|
|
5,213,353 |
|
|
39,061,667 |
|
|
19,214,207 |
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
26,927,988 |
|
|
21,938,733 |
|
|
86,786,686 |
|
|
69,456,593 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(26,927,988 |
) |
|
(21,938,733 |
) |
|
(86,286,686 |
) |
|
(68,558,394 |
) |
|
|
|
|
|
|
|
|
|
Other expense |
|
(3,608 |
) |
|
(3,145 |
) |
|
(7,505 |
) |
|
(6,330 |
) |
Interest expense |
|
(321 |
) |
|
— |
|
|
(794 |
) |
|
— |
|
Interest income |
|
297,003 |
|
|
192,577 |
|
|
1,270,620 |
|
|
736,330 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(26,634,914 |
) |
$ |
(21,749,301 |
) |
$ |
(85,024,365 |
) |
$ |
(67,828,394 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
$ |
(0.92 |
) |
$ |
(0.93 |
) |
$ |
(2.99 |
) |
$ |
(2.94 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
29,085,767 |
|
|
23,517,007 |
|
|
28,388,901 |
|
|
23,056,928 |
|
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