Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics, today reported
financial results and business highlights for the first quarter
ended March 31, 2019.
“Since ELZONRIS became commercially available in January, we
have been very pleased with the progress we have made executing our
launch plan,” stated Robert Francomano, SVP and Global Head of
Commercial. “Our entire organization is working hard to ensure
patients with BPDCN have access to ELZONRIS. Although still early,
we believe the launch is progressing extremely well and remain
poised for a very successful 2019 and beyond.”
Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented
“We have built a solid foundation for growth, driven by our launch
of ELZONRIS for patients with BPDCN. We are executing our
commercial plan, including pursuing ongoing efforts to unlock
additional value from ELZONRIS in other indications as well as from
our entire pipeline, all with the goal of improving the lives of
patients with cancer around the world.”
First Quarter 2019 Financial Results ReviewNet
revenue for ELZONRIS was $5.05 million for the quarter ended March
31, 2019. Stemline began commercial sales of ELZONRIS within the
United States in January 2019.
Stemline ended the first quarter with $124.4 million in cash,
cash equivalents and investments. For the first quarter, Stemline
had a net loss of $27.4 million. Cash expenditures for the first
quarter of 2019 was $21.9 million.
Research and development expenses were $17.0 million for the
first quarter of 2019, which reflects an increase of $4.3 million
compared with $12.7 million for the first quarter of 2018. The
higher cost was primarily driven by expense recorded related to
repayment of research funding as a result of the first commercial
sale of ELZONRIS.
Selling, general and administrative expenses were $16.0 million
for the first quarter of 2019, which reflects an increase of $10.1
million compared with $5.9 million for the first quarter of 2018.
The increase in costs were primarily attributable to launch
expenses in support of the commercialization of ELZONRIS.
Recent Corporate Developments and Program
Highlights
ELZONRIS™ (tagraxofusp) – Blastic plasmacytoid dendritic
cell neoplasm (BPDCN)
- ELZONRIS was approved by the FDA on December 21, 2018 and
commercially available for patients with BPDCN in the U.S. in
January 2019.
- The New England Journal of Medicine published the pivotal trial
results in its April 25th edition.
- We submitted a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) in January 2019 seeking marketing
approval in Europe. The MAA was granted accelerated assessment and
is currently under review.
ELZONRIS – Market Expansion Efforts
- We are conducting clinical trials to evaluate ELZONRIS in
additional indications, including chronic myelomonocytic leukemia
(CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).
- Based on clinical results observed in patients with CMML and
MF, we are evaluating next steps, including potential
registrational pathways. For CMML, we intend to provide our
registration-directed plans mid-year.
- We are also evaluating additional expansion opportunities,
including maintenance therapy after stem cell transplant in
patients with BPDCN.
- In parallel, we plan to expand our clinical efforts later this
year and next into subsets of AML patients, including those
enriched for CD123+ expression.
- We expect to provide periodic updates on these programs
throughout this year and next at scientific conferences.
ASCO Conference
- ELZONRIS clinical trial data in CMML and MF have been selected
for two poster presentations at the 2019 American Society of
Clinical Oncology (ASCO) conference in June.
Other pipeline candidates
- We expect to provide periodic updates on our other product
candidates, SL-701, SL-801, SL-901, and SL-1001, later this
year.
Conference Call InformationStemline will host a
conference call and live webcast today at 8:00 a.m. ET to discuss
first quarter 2019 financial results and recent business
activities. The conference call can be accessed by dialing
1-800-667-5617 (domestic) or 1-334-323-0509 (international) and
referring to conference ID 2090827.
The live webcast can be accessed via the company’s website
(www.stemline.com), at the bottom of the “Investors & Media”
section in the “News & Events” page. The webcast will be
archived and made available for replay on the company’s website
shortly after the event.
About ELZONRIS™ ELZONRIS (tagraxofusp-erzs), a
CD123-directed cytotoxin, is approved by the U.S. Food and Drug
Administration (FDA) and commercially available in the U.S. for the
treatment of adult and pediatric patients, two years or older, with
blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full
prescribing information in the U.S., visit www.ELZONRIS.com. In
Europe, a marketing authorization application (MAA) is under review
by the European Medicines Agency (EMA). 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 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, as well as other markers. For more
information, please visit the BPDCN disease awareness website at
www.bpdcninfo.com.
About CD123CD123 is a cell surface target
expressed on a wide range of myeloid tumors including blastic
plasmacytoid dendritic cell neoplasm (BPDCN), certain
myeloproliferative neoplasms (MPNs) including chronic
myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute
myeloid leukemia (AML) (and potentially enriched in certain AML
subsets), myelodysplastic syndrome (MDS), and chronic myeloid
leukemia (CML). CD123 has also been reported on certain lymphoid
malignancies including multiple myeloma (MM), acute lymphoid
leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL),
and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has
been detected on some solid tumors as well as autoimmune disorders
including cutaneous lupus and scleroderma.
About Stemline Therapeutics Stemline
Therapeutics, Inc. is a commercial-stage biopharmaceutical company
focused on the development and commercialization of novel oncology
therapeutics. ELZONRIS™ (tagraxofusp), a targeted therapy directed
to CD123, is FDA-approved and commercially available in the U.S.
for the treatment of adult and pediatric patients, two years or
older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
In Europe, a marketing authorization application (MAA) is under
review by the European Medicines Agency (EMA). 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). For more information, please visit the company’s
website at www.stemline.com.
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
U.S. launch and commercialization; the success of our MAA
submission to the EMA and potential launch in Europe; the success
and timing of our clinical trials and preclinical studies for our
product and product candidates, including ELZONRIS in additional
indications and our other pipeline 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 product 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
payors) 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 product and product candidates; delays, interruptions, or
failures in the manufacture and supply of our product 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
|
|
March
31, 2019(Unaudited) |
|
December 31, 2018 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
24,014,510 |
|
$ |
9,443,667 |
|
Short-term investments |
|
|
100,337,983 |
|
|
50,662,189 |
|
Accounts receivable |
|
|
5,618,900 |
|
|
— |
|
Inventories |
|
848,493 |
|
— |
|
Prepaid expenses and other current assets |
|
3,120,926 |
|
2,952,996 |
|
Total current assets |
|
133,940,812 |
|
63,058,852 |
|
Property and equipment,
net |
|
273,399 |
|
222,413 |
|
Right-of-use asset, net |
|
1,738,680 |
|
— |
|
Other Assets |
|
212,305 |
|
212,305 |
|
Total assets |
|
$ |
136,165,196 |
|
$ |
63,493,570 |
|
Liabilities and stockholders’
equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
25,413,021 |
|
$ |
21,153,062 |
|
Right-of-use liability – current portion |
|
|
1,023,678 |
|
|
— |
|
Other current liabilities |
|
|
6,021 |
|
|
65,862 |
|
Total current liabilities |
|
26,442,720 |
|
21,218,924 |
|
Right-of-use liability |
|
818,303 |
|
— |
|
Other liabilities |
|
12,011 |
|
72,591 |
|
Total liabilities |
|
27,273,034 |
|
21,291,515 |
|
Stockholders’
equity: |
|
|
|
|
|
Preferred stock $0.0001 par value, 5,000,000 shares authorized,
none issued and outstanding at March 31, 2019 and December 31,
2018 |
|
— |
|
— |
|
Common stock $0.0001 par value, 53,750,000 shares authorized at
March 31, 2019 and December 31, 2018. 43,576,081 shares issued and
outstanding at March 31, 2019 and 31,943,186 shares
issued and outstanding at December 31,
2018 |
|
4,358 |
|
3,194 |
|
Additional paid-in capital |
|
425,410,295 |
|
331,343,484 |
|
Accumulated other comprehensive loss |
|
(27,161 |
) |
(56,559 |
) |
Accumulated deficit |
|
(316,495,330 |
) |
(289,088,064 |
) |
Total stockholders’ equity |
|
108,892,162 |
|
42,202,055 |
|
Total liabilities and
stockholders’ equity |
|
$ |
136,165,196 |
|
$ |
63,493,570 |
|
|
|
|
|
|
|
|
|
Table 2. Stemline Therapeutics, Inc. - Statements of
Operations (Unaudited)
|
Three Months Ended March 31, |
|
|
|
2019 |
|
|
2018 |
|
Revenues: |
|
|
|
|
Product revenue, net |
$ |
5,048,590 |
|
$ |
— |
|
Operating expenses:Cost
of goods sold |
|
85,728 |
|
|
— |
|
Research and development |
|
16,953,822 |
|
|
12,708,058 |
|
Selling, general and
administrative |
|
15,953,968 |
|
|
5,938,600 |
|
Total operating expenses |
|
32,993,518 |
|
|
18,646,658 |
|
Loss from
operations |
|
(27,944,928 |
) |
|
(18,646,658 |
) |
Other expense |
|
(4,616 |
) |
|
(3,897 |
) |
Interest income |
|
538,584 |
|
|
233,802 |
|
Net loss before income
taxes |
|
(27,410,960 |
) |
|
(18,416,753 |
) |
|
|
|
|
|
Income tax benefit |
|
3,694 |
|
|
— |
|
|
|
|
|
|
Net loss |
$ |
(27,407,266 |
) |
$ |
(18,416,753 |
) |
Net loss per common
share: |
|
|
|
|
Basic and Diluted |
$ |
(0.73 |
) |
$ |
(0.69 |
) |
Weighted-average shares
outstanding:Basic and Diluted |
|
37,550,931 |
|
|
26,845,983 |
|
|
|
|
|
|
|
|
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