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 third quarter
ended September 30, 2019.
Robert Francomano, SVP and Global Head of Commercial, stated,
“We are very pleased with the sustained revenue generation and
significant progress we continue to make on the ELZONRIS launch.
Notably, we observed a greater than 20% increase in estimated new
patient starts quarter over quarter, which is a testament to our
execution and bodes very well for the future of the brand.
Additionally, we implemented a number of strategies designed to
increase the speed and accuracy of BPDCN diagnoses, not only in
hematology and hematopathology but also within the dermatology and
dermatopathology segments - where our data indicate the
preponderance of misdiagnoses occurs. Our entire organization is
focused on ensuring that patients with BPDCN gain access to
ELZONRIS, and we look to capitalize on the positive trends we are
seeing to ensure continued performance through 2020 and
beyond.”
Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented,
“We are very pleased with the continued commercial performance and
our efforts to realize additional value from ELZONRIS in other
indications. Based on encouraging clinical data observed in the
first stages of our clinical trial in chronic myelomonocytic
leukemia (CMML), combined with a strong rationale for targeting
CD123 in this disease setting, we view CMML as our next key
indication. We anticipate opening enrollment of the
registration-directed stage of the trial in the next few months. We
look forward to data and regulatory updates around this program,
including in both relapsed/refractory and first-line patients, by
the second half of 2020.”
Third Quarter 2019 Financial Results Review Net
revenue for ELZONRIS increased to $13.3 million for the quarter
ended September 30, 2019.
Stemline ended the third quarter with $174.5 million in cash,
cash equivalents and short-term investments. For the third quarter,
Stemline reported a net loss of $14.9 million, with net cash
expenditures of $11.8 million.
Research and development expenses were $12.3 million for the
third quarter of 2019, which reflects an increase of $0.5 million
compared with $11.8 million for the third quarter of 2018. The
higher costs were primarily due to increased investment as we
continue to explore new indications for ELZONRIS.
Selling, general and administrative expenses were $15.4 million
for the third quarter of 2019, which reflects an increase of $5.8
million compared with $9.6 million for the third quarter of 2018.
The increase in costs were primarily attributable to ongoing
commercial launch expenses for ELZONRIS.
Recent Business Highlights
Commercial
- We continue to create a positive reimbursement environment for
ELZONRIS that we expect will further enhance the value proposition
of the brand and generate more patient starts for the foreseeable
future. In particular,
- Awarding by the CMS (the Centers for Medicare and Medicaid
Services) of NTAP (New Technology Add-On Payment), granted to
therapies that are deemed to deliver a substantial clinical
improvement over existing therapies, for ELZONRIS went into effect
on October 1, 2019.
- Assignment of an ELZONRIS specific J-Code which makes billing
for treatment easier and speeds up claims processing time, also in
effect October 1st.
- With regard to private payers, ELZONRIS now has favorable
coverage for over 170 million lives, with policy decisions to the
label for key large commercial payers.
- We continue to execute on our brand and disease awareness
efforts which are designed to raise the profile of BPDCN and
underscore the importance of testing patients for CD123,
particularly within the dermatology and dermatopathology
segment.
ELZONRIS Product Line Extension Efforts
- In an ongoing effort to pursue market expansion opportunities,
ELZONRIS is being investigated in a variety of clinical trials and
indications, with a number of others planned. By the end of 2020,
we expect substantial data and regulatory updates, including in the
following programs:
Chronic myelomonocytic leukemia (CMML)
- We plan to open an additional single-arm cohort, Stage 3, of
patients with relapsed/refractory CMML to the currently enrolling
trial in the next few months. In the first part of Stage 3 (Stage
3a), enrichment strategies (e.g. high CD123 expression levels) and
certain potential efficacy endpoints, including spleen size
reduction, symptom score improvement, and bone marrow complete
response with partial hematologic recovery will be evaluated.
First-line CMML patients not expected to benefit from available
therapies will also be enrolled.
- Stage 3a endpoints 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.
- We expect to provide data from Stage 3a, in both
relapsed/refractory and first-line patients, as well as further
regulatory updates by the end of 2020.
Myelofibrosis (MF)
- ELZONRIS clinical data from the ongoing Phase 1/2 trial in
patients with relapsed/refractory MF were selected for oral
presentation at the upcoming American Society of Hematology (ASH)
conference.
- We are encouraged by the clinical data thus far and are
expanding the Stage 2 cohort of the currently enrolling Phase 2
trial of ELZONRIS in patients with relapsed/refractory MF.
- We will continue to assess ELZONRIS in relapsed/refractory MF
patients as a whole as well as in certain patient subsets of
interest including patients with baseline thrombocytopenia (a
setting where other agents in this area may require dose
interruption or reduction), monocytosis (a potential poor
prognostic feature), and high CD123 expression levels.
- We expect to provide additional data, including in various
subsets of interest, by the end of 2020, and possibly before.
Maintenance therapy post-stem cell transplant (SCT) in
BPDCN
- The Phase 2 investigator-sponsored clinical trial of ELZONRIS
in patients with BPDCN as maintenance therapy post- 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 updates by the end of 2020, and possibly
before.
Acute myeloid leukemia (AML)
- A Phase 1/2 investigator-sponsored trial is currently ongoing
with ELZONRIS in combination with azacitidine and venetoclax in
patients with relapsed/refractory AML, elderly AML unfit for
chemotherapy, and high-risk myelodysplastic syndrome (MDS).
- Phase 1/2 investigator-sponsored trials are currently planned
with ELZONRIS in combination with other agents in patients with
relapsed/refractory AML and elderly AML unfit for chemotherapy,
with high CD123 expression levels and/or BPDCN-like features.
- We expect to provide updates by the end of 2020, and possibly
before.
Ex-U.S.
- In January 2019, Stemline submitted a Marketing Authorization
Application to the European Medicines Agency (EMA), seeking
approval of ELZONRIS for the treatment of adult patients with
BPDCN. We continue to interact with the EMA regarding the
application and a scientific advisory group meeting is expected to
occur in the first quarter of 2020. Based on this timeline, we
expect an opinion or further questions from the Committee for
Medicinal Products for Human Use (CHMP) in the first quarter
2020.
- ELZONRIS clinical trial data in BPDCN was presented via oral
presentation on October 13th at the Japanese Society of Hematology
(JSH) meeting in Tokyo, Japan.
Additional Pipeline Candidates
- Felezonexor (SL-801) is a reversible inhibitor of XPO1. Updated
Phase 1 data were presented at the European Society for Medical
Oncology (ESMO) meeting. The trial is ongoing, and we intend to
provide further updates as the Phase 1 trial continues.
- Stemline is also developing its preclinical assets, SL-1001
(RET kinase inhibitor) and SL-901 (kinase inhibitor), which are
both in IND-enabling studies and are expected to enter the clinic
next year.
Conference Call Information The conference call
can be accessed by dialing 1-800-367-2403 (domestic) or
1-334-777-6978 (international) and referring to conference ID
9176352. 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. ELZONRISÒ (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 and
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: felezonexor (SL-801) (XPO1 inhibitor; Phase 1
in advanced solid tumor patients ongoing), SL-1001 (novel RET
kinase inhibitor, IND-enabling studies ongoing), SL-701
(immunotherapeutic; Phase 2 in glioblastoma patients completed),
and SL-901 (novel kinase inhibitor; prior abbreviated European
Phase 1, IND-enabling studies ongoing). 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 (Unaudited)
|
|
September 30, 2019 |
|
December 31, 2018 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
27,378,573 |
|
$ |
9,443,667 |
|
Short-term investments |
|
|
147,152,571 |
|
|
50,662,189 |
|
Accounts receivable |
|
|
16,566,838 |
|
|
— |
|
Inventories |
|
2,856,876 |
|
— |
|
Prepaid expenses and other current assets |
|
2,547,101 |
|
2,952,996 |
|
Total current assets |
|
196,501,959 |
|
63,058,852 |
|
Property and equipment,
net |
|
213,036 |
|
222,413 |
|
Operating lease right-of-use
assets |
|
1,240,455 |
|
— |
|
Other assets |
|
212,305 |
|
212,305 |
|
Total assets |
|
$ |
198,167,755 |
|
$ |
63,493,570 |
|
Liabilities and stockholders’
equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
21,376,369 |
|
$ |
21,153,062 |
|
Operating lease liabilities – current portion |
|
|
1,061,721 |
|
|
— |
|
Other current liabilities |
|
|
10,000 |
|
|
65,862 |
|
Total current liabilities |
|
22,448,090 |
|
21,218,924 |
|
Operating lease
liabilities |
|
277,758 |
|
— |
|
Other liabilities |
|
6,949 |
|
72,591 |
|
Total liabilities |
|
22,732,797 |
|
21,291,515 |
|
Stockholders’
equity: |
|
|
|
|
|
Preferred stock $0.0001 par value, 5,000,000 shares authorized,
none issued and outstanding at September 30, 2019 and December 31,
2018 |
|
— |
|
— |
|
Common stock $0.0001 par value, 83,750,000 shares authorized at
September 30, 2019 and 53,750,000 shares authorized at December 31,
2018. 50,010,233 shares issued and outstanding at September 30,
2019 and 31,943,186 shares issued and outstanding at
December 31, 2018 |
|
5,001 |
|
3,194 |
|
Additional paid-in capital |
|
523,656,945 |
|
331,343,484 |
|
Accumulated other comprehensive loss |
|
(1,724 |
) |
(56,559 |
) |
Accumulated deficit |
|
(348,225,264 |
) |
(289,088,064 |
) |
Total stockholders’ equity |
|
175,434,958 |
|
42,202,055 |
|
Total liabilities and stockholders’ equity |
|
$ |
198,167,755 |
|
$ |
63,493,570 |
|
Table 2. Stemline Therapeutics, Inc. - Statements of
Operations (Unaudited)
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
13,332,580 |
|
$ |
— |
|
$ |
31,387,878 |
|
$ |
— |
|
Income: |
|
|
|
|
|
|
|
|
Grant income |
|
— |
|
|
— |
|
|
— |
|
|
500,000 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of goods sold |
|
1,071,673 |
|
|
— |
|
|
1,740,560 |
|
|
— |
|
Research and development |
|
12,332,208 |
|
|
11,758,025 |
|
|
40,177,424 |
|
|
35,650,147 |
|
Selling, general and administrative |
|
15,413,688 |
|
|
9,647,336 |
|
|
50,370,163 |
|
|
24,208,551 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
28,817,569 |
|
|
21,405,361 |
|
|
92,288,147 |
|
|
59,858,698 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(15,484,989 |
) |
|
(21,405,361 |
) |
|
(60,900,269 |
) |
|
(59,358,698 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
714 |
|
|
— |
|
|
(3,610 |
) |
|
(3,897 |
) |
Interest income |
|
604,510 |
|
|
361,365 |
|
|
1,753,232 |
|
|
973,144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income taxes |
$ |
(14,879,765 |
) |
$ |
(21,043,996 |
) |
$ |
(59,150,647 |
) |
$ |
(58,389,451 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax (expense) benefit |
|
(8,747 |
) |
|
— |
|
|
13,447 |
|
|
— |
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(14,888,512 |
) |
$ |
(21,043,996 |
) |
$ |
(59,137,200 |
) |
$ |
(58,389,451 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share:Basic
and Diluted |
$ |
(0.34 |
) |
$ |
(0.73 |
) |
$ |
(1.46 |
) |
$ |
(2.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding:Basic and Diluted |
|
43,733,163 |
|
|
29,018,507 |
|
|
40,486,766 |
|
|
28,253,750 |
|
|
|
|
|
|
|
|
|
|
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