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 second quarter
ended June 30, 2019.
“We are very excited with the progress we continue to make on
the ELZONRIS U.S. launch. Our commercial team continues to generate
strong momentum, as evidenced by robust sales, steady increases in
new patient starts and a broadening prescriber base,” stated Robert
Francomano, SVP and Global Head of Commercial. “Our entire
organization is focused on ensuring patients with BPDCN gain access
to ELZONRIS, and given the trends we are seeing, we remain poised
for a successful 2019 and beyond.”
Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented:
“We are very pleased with the continued strong commercial
performance and the rapid, broad-based adoption of ELZONRIS in the
marketplace. 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 building a leading biopharmaceutical company and
improving the lives of patients with cancer around the world.”
Second Quarter 2019 Financial Results ReviewNet
revenue for ELZONRIS was $13.0 million for the quarter ended June
30, 2019. Stemline began commercial sales of ELZONRIS within the
United States in January 2019.
Stemline ended the second quarter with $103.9 million in cash,
cash equivalents and investments. For the second quarter, Stemline
had a net loss of $16.8 million. The net cash expenditures for the
second quarter of 2019 was $20.5 million.
Research and development expenses were $10.9 million for the
second quarter of 2019, which reflects a decrease of $0.3 million
compared with $11.2 million for the second quarter of 2018. The
lower costs in the current period were primarily due to expenses in
the prior year related to our biologics license application (BLA)
filing for ELZONRIS with the FDA.
Selling, general and administrative expenses were $19.0 million
for the second quarter of 2019, which reflects an increase of $10.4
million compared with $8.6 million for the second quarter of 2018.
The increase in costs were primarily attributable to pre-launch and
launch expenses in support of the commercialization of ELZONRIS in
the U.S. and potential launch in the European Union.
Recent Business Highlights
Commercial
- Net revenue of ELZONRIS were $13.0 million during the second
quarter, representing a 157% increase over last quarter.
- The Centers for Medicare and Medicaid Services (CMS) recently
assigned a J-Code for ELZONRIS, which happened one quarter earlier
than we expected. The J-Code is a permanent code assigned to
ELZONRIS by CMS and used by Medicare, Medicaid, and commercial
payers for billing and claims processing. With a permanent J-code,
ELZONRIS billing becomes more efficient, particularly in the
outpatient setting.
- On the private payer side, ELZONRIS now has favorable coverage
for over 100 million lives, with coverage policy decisions to the
label for key commercial payers.
- We continue to execute on our disease awareness efforts which
are designed to raise the profile of BPDCN and underscore the
importance of CD123 testing.
Market Expansion Efforts
- Blastic plasmacytoid dendritic cell neoplasm (BPDCN)• Stemline
announced today that the Phase 2 investigator-sponsored clinical
trial of ELZONRIS in patients with BPDCN as maintenance therapy
post-stem cell transplant (SCT) has been granted regulatory
authorization to proceed. The trial will evaluate the safety and
feasibility of ELZONRIS in the maintenance setting for patients
with BPDCN after SCT. We expect to provide further program updates
later this year.
- Chronic myelomonocytic leukemia (CMML)• ELZONRIS clinical
data from its ongoing Phase 2 clinical trial in patients with CMML
were presented at the 2019 American Society of Clinical Oncology
(ASCO) annual meeting in Chicago, Illinois and at the 24th Congress
of the European Hematology Association (EHA) in Amsterdam,
Netherlands.• We plan to open an additional single-arm cohort,
Stage 3, of patients with previously-treated CMML to the currently
enrolling trial later this year. In the first part of Stage 3
(Stage 3a), enrichment strategies and certain efficacy endpoints,
including spleen size reduction and bone marrow complete response
with partial hematologic recovery, will be assessed for potential
inclusion in the confirmatory cohort (Stage 3b), that will aim to
provide the primary evidence of efficacy to support potential
registration.
- Myelofibrosis (MF)• ELZONRIS clinical data from its
ongoing Phase 2 clinical trial in patients with MF were presented
at the 2019 American Society of Clinical Oncology (ASCO) annual
meeting in Chicago, Illinois and at the 24th Congress of the
European Hematology Association (EHA) in Amsterdam,
Netherlands.• The trial continues to enroll and we expect to
provide further program updates later this year.
- Systemic sclerosis• ELZONRIS preclinical results in
systemic sclerosis, an autoimmune disorder in which CD123+
plasmacytoid dendritic cells (pDCs) play a role in disease
pathogenesis, were presented at the Annual European Congress of
Rheumatology (EULAR) in Madrid, Spain.
- Acute myeloid leukemia (AML) and others• ELZONRIS in
combination with other agents is currently being evaluated in an
investigator-sponsored Phase 1/2 trial of patients with AML and
high-risk myelodysplastic syndrome (MDS). Additional
investigator-sponsored trials of ELZONRIS in combination with other
agents in patients with subsets of AML that are enriched for CD123+
and/or BPDCN-like features are targeted to open in the 4Q19/1H20
timeframe. Other indications are also under consideration.
Ex-U.S.
- Stemline continues to build out a European commercial
infrastructure in advance of potential approval by the European
Medicines Agency (EMA). The ELZONRIS marketing authorization
application (MAA) is under review on a standard timeline. In June
2019, we received the day 120 list of questions relating to
chemistry, manufacturing and controls (CMC), quality, non-clinical,
and all stages of the clinical trial, including stage 4 largely
involving lyophilized drug product. We have requested, and
received, a clock stop extension. A scientific advisory group
meeting is being planned. Based on this timeline, we expect an
opinion from the Committee for Medicinal Products for Human Use
(CHMP) in 1H20. In anticipation of potential regulatory success, we
have started to hire personnel to meet the needs of a possible
mid-2020 European commercial launch.
- Stemline has instituted a global Early Access Program (EAP)
whereby physicians may seek access to ELZONRIS outside of a
clinical trial and/or before it is commercially available.
- ELZONRIS clinical trial data in patients with BPDCN continue to
be featured at prominent international hematological conferences
with recent presentations in Europe and an upcoming oral
presentation at a major medical meeting in Asia.
Additional Pipeline Candidates
- Stemline continues to advance its clinical stage assets,
including SL-801 (felezonexor), a reversible inhibitor of XPO1.
Updated Phase 1 data were selected for presentation at the upcoming
European Society for Medical Oncology (ESMO) meeting. Stemline is
also developing its preclinical assets SL-1001 (RET kinase
inhibitor) and SL-901 (kinase inhibitor), both of which are in
IND-enabling studies and are expected to enter the clinic next
year.
Conference Call InformationStemline will host a
conference call and live webcast today at 8:00 a.m. ET to discuss
second quarter 2019 financial results and recent business
activities. The conference call can be accessed by dialing
1-888-220-8451 (domestic) or 1-323-794-2588 (international) and
referring to conference ID 7887580.
The 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, and will be available live
and for replay 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
|
|
June
30, 2019(Unaudited) |
|
December 31, 2018 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
16,965,619 |
|
$ |
9,443,667 |
|
Short-term investments |
|
|
86,918,164 |
|
|
50,662,189 |
|
Accounts receivable |
|
|
15,093,121 |
|
|
— |
|
Inventories |
|
3,655,017 |
|
— |
|
Prepaid expenses and other current assets |
|
3,596,436 |
|
2,952,996 |
|
Total current assets |
|
126,228,357 |
|
63,058,852 |
|
Property and equipment,
net |
|
238,729 |
|
222,413 |
|
Right-of-use asset, net |
|
1,469,714 |
|
— |
|
Other assets |
|
212,305 |
|
212,305 |
|
Total assets |
|
$ |
128,149,105 |
|
$ |
63,493,570 |
|
Liabilities and stockholders’
equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
25,748,958 |
|
$ |
21,153,062 |
|
Right-of-use liability – current portion |
|
|
1,042,526 |
|
|
— |
|
Other current liabilities |
|
|
6,142 |
|
|
65,862 |
|
Total current liabilities |
|
26,797,626 |
|
21,218,924 |
|
Right-of-use liability |
|
550,496 |
|
— |
|
Other liabilities |
|
9,496 |
|
72,591 |
|
Total liabilities |
|
27,357,618 |
|
21,291,515 |
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock $0.0001 par value, 5,000,000 shares authorized,
none issued and outstanding at June 30, 2019 and December 31,
2018 |
|
— |
|
— |
|
Common stock $0.0001 par value, 83,750,000 shares authorized at
June 30, 2019 and 53,750,000 shares authorized at December 31,
2018. 43,875,679 shares issued and outstanding at June 30, 2019 and
31,943,186 shares issued and outstanding at
December 31, 2018 |
|
4,388 |
|
3,194 |
|
Additional paid-in capital |
|
434,071,363 |
|
331,343,484 |
|
Accumulated other comprehensive income (loss) |
|
52,488 |
|
(56,559 |
) |
Accumulated deficit |
|
(333,336,752 |
) |
(289,088,064 |
) |
Total stockholders’ equity |
|
100,791,487 |
|
42,202,055 |
|
Total liabilities and
stockholders’ equity |
|
$ |
128,149,105 |
|
$ |
63,493,570 |
|
|
|
|
|
|
|
|
|
Table 2. Stemline Therapeutics, Inc. - Statements of
Operations (Unaudited)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
13,006,709 |
|
|
— |
|
$ |
18,055,299 |
|
|
— |
|
Income: |
|
|
|
|
|
|
|
|
Grant income |
|
— |
|
$ |
500,000 |
|
|
— |
|
$ |
500,000 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of goods sold |
|
583,159 |
|
|
— |
|
|
668,888 |
|
|
— |
|
Research and development |
|
10,891,394 |
|
|
11,184,064 |
|
|
27,845,216 |
|
|
23,892,122 |
|
Selling, general and
administrative |
|
19,002,508 |
|
|
8,622,616 |
|
|
34,956,475 |
|
|
14,561,216 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
30,477,061 |
|
|
19,806,680 |
|
|
63,470,579 |
|
|
38,453,338 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(17,470,352 |
) |
|
(19,306,680 |
) |
|
(45,415,280 |
) |
|
(37,953,338 |
) |
|
|
|
|
|
|
|
|
|
Other expense |
|
(262 |
) |
|
(123 |
) |
|
(4,878 |
) |
|
(4,020 |
) |
Interest income |
|
610,692 |
|
|
378,100 |
|
|
1,149,276 |
|
|
611,902 |
|
Net loss before income taxes |
$ |
(16,859,922 |
) |
$ |
(18,928,703 |
) |
$ |
(44,270,882 |
) |
$ |
(37,345,456 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
18,500 |
|
|
— |
|
|
22,194 |
|
|
— |
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(16,841,422 |
) |
$ |
(18,928,703 |
) |
$ |
(44,248,688 |
) |
$ |
(37,345,456 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share:Basic
and Diluted |
$ |
(0.42 |
) |
$ |
(0.66 |
) |
$ |
(1.14 |
) |
$ |
(1.34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding:Basic and Diluted |
|
40,108,267 |
|
|
28,567,982 |
|
|
38,836,664 |
|
|
27,851,707 |
|
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