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 fourth quarter
ended December 31, 2019.
Robert Francomano, Chief Commercial Officer of Stemline, stated,
“Overall, we are very pleased with the solid demand we generated
for ELZONRIS in the first year of launch and look to expand our
reach in the market as we continue to build a strong commercial
foundation. Importantly, new medical claims data align with our
independent analyses which support our market size estimates of the
BPDCN U.S. patient population. We believe there is significant
growth potential ahead and are poised to capture greater market
penetration. Based on market assessments, we have already started
to implement a new host of tactics to better situate ELZONRIS in
this dynamic and emerging market – all of which should benefit
growth later this year.”
Ivan Bergstein, CEO of Stemline, commented, “Our first year of
launch has created a strong foundation for the future growth of the
company. We are investing in multiple label expansion opportunities
for ELZONRIS in such indications as CMML, MF, and AML, as well as
advancing our other pipeline products including felezonexor, our
XPO1 inhibitor and SL-1001, our RET kinase inhibitor, toward key
inflection points over the coming year and beyond.”
Fourth Quarter 2019 Financial Results
Review
Net product revenue for ELZONRIS was $11.8 million for the
quarter ended December 31, 2019. Stemline began commercial sales of
ELZONRIS within the United States in January 2019.
Stemline ended the fourth quarter with $164.4 million in cash,
cash equivalents and short-term investments. For the fourth
quarter, Stemline reported a net loss of $17.7 million, with net
cash expenditures of $10.1 million.
Research and development expenses were $10.5 million for the
fourth quarter of 2019, which reflects decrease of $1.6 million
compared with $12.1 million for the fourth quarter of 2018. The
lower expenses are primarily attributable to higher costs incurred
during 4Q18 related to the ELZONRIS BLA filing and manufacturing of
ELZONRIS prior to FDA approval.
Selling, general and administrative expenses were $16.5 million
for the fourth quarter of 2019, which reflects an increase of $1.6
million compared with $14.9 million for the fourth quarter of 2018.
The increase in costs were primarily attributable to ongoing U.S.
launch expenses for ELZONRIS and pre-launch ELZONRIS-related costs
in support of a potential regulatory approval and launch in the
EU.
Corporate Highlights and Key Commercial and Clinical
Milestones
BPDCN
- $43.2 million in net revenues for ELZONRIS in 2019
- IQVIA medical claims data identified approximately 534 unique
patients in the U.S. in 2018 with at least one claim of Blastic
NK-Cell Lymphoma, a former name of BPDCN
- Marketing Authorization Application (MAA) under review by
European Medicines Agency (EMA) for potential approval in the
EU
- Phase 1/2 trial of ELZONRIS in patients with BPDCN in the
maintenance setting, post-stem cell transplant (SCT), open for
enrollment
Chronic Myelomonocytic Leukemia (CMML)
- The CMML expansion cohort, Stage 3a, is open for enrollment of
two patient populations: relapsed/refractory patients, and
first-line, poor prognosis patients not expected to benefit from
first line cytoreductive treatment
- Results from Stage 3a are expected to inform the design of the
subsequent Stage 3b confirmatory cohort for potential
registration
- We expect to provide updates from this trial in ~4Q20/1Q21
Myelofibrosis (MF)
- At ASH 2019, ELZONRIS data in patients with relapsed/refractory
MF was the subject of an oral presentation
- In the MF clinical trial, ELZONRIS demonstrated efficacy
(spleen size reductions and total symptom score [TSS] reductions)
with a predictable and manageable safety profile, including in
patients with poor prognostic factors, such as thrombocytopenia,
CMML-type features/monocytosis, and clonal evolution
- The MF cohort of the ongoing trial has been expanded to include
20-25 additional patients
- We are evaluating relapsed/refractory patients and specific
subsets of patients, including patients with monocytosis,
thrombocytopenia, and CD123 positivity
- We expect to provide updates from this trial in ~4Q20/1Q21
Acute Myeloid Leukemia (AML)
- A Phase 1/2 trial of ELZONRIS in combination with other agents
in patients with relapsed/refractory AML, treatment-naive AML unfit
for chemotherapy, and high-risk myelodysplastic syndrome (MDS) is
currently enrolling patients. CD123 expression levels are also
being evaluated. We expect to provide updates later this year
Conference Call Information
The company will host a conference call and webcast on Monday,
March 16, 2020 at 8:00 a.m. ET. The conference call can be accessed
by dialing 1-800-367-2403 (domestic) or 1-334-777-6978
(international) and referring to conference ID 7728185.
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), a targeted therapy directed to
CD123, 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 CD123+ indications, including chronic myelomonocytic
leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML),
and others are planned, including a CD123+ all-comers trial.
About BPDCN
BPDCN, formerly blastic NK-cell lymphoma, is an aggressive
hematologic malignancy, often with cutaneous manifestations, with
historically poor outcomes. 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.
The World Health Organization (WHO) termed this disease “BPDCN” in
2008; previous names included blastic NK cell lymphoma and
agranular CD4+/CD56+ hematodermic neoplasm. For more information,
please visit the BPDCN disease awareness website at
www.bpdcninfo.com.
About CD123
CD123 is a cell surface target expressed on a wide range of
malignancies 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 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+ cells have been detected in the tumor
microenvironment of several solid tumors as well as in certain
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 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) acute
myeloid leukemia (AML), and additional trials and indications are
planned. Additional pipeline candidates include: felezonexor
(SL-801) (XPO1 inhibitor; Phase 1 in advanced solid tumor patients
ongoing) and SL-1001 (RET kinase inhibitor, IND-enabling studies
ongoing). For more information, please visit the company’s website
at www.stemline.com.
Forward-Looking Statements
Some 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
|
|
December 31, 2019 |
|
December 31, 2018 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,561,712 |
|
$ |
9,443,667 |
|
Short-term investments |
|
|
150,869,056 |
|
|
50,662,189 |
|
Accounts receivable, net |
|
|
15,120,229 |
|
|
— |
|
Inventories, net |
|
1,151,373 |
|
— |
|
Prepaid expenses and other current assets |
|
4,459,127 |
|
2,952,996 |
|
Total current assets |
|
185,161,497 |
|
63,058,852 |
|
Property and equipment,
net |
|
191,158 |
|
222,413 |
|
Operating lease right-of-use
assets |
|
1,317,598 |
|
— |
|
Other assets |
|
308,751 |
|
212,305 |
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
186,979,004 |
|
$ |
63,493,570 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
21,952,048 |
|
$ |
21,153,062 |
|
Operating lease liabilities – current portion |
|
|
1,169,764 |
|
|
— |
|
Other current liabilities |
|
|
10,125 |
|
|
65,862 |
|
Total current liabilities |
|
23,131,937 |
|
21,218,924 |
|
Operating lease
liabilities |
|
226,306 |
|
— |
|
Other liabilities |
|
4,370 |
|
72,591 |
|
Total liabilities |
|
23,362,613 |
|
21,291,515 |
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock $0.0001 par value, 5,000,000 shares authorized,
none issued and outstanding at December 31, 2019 and December 31,
2018 |
|
— |
|
— |
|
Common stock $0.0001 par value, 83,750,000 shares authorized at
December 31, 2019 and 53,750,000 shares authorized at December 31,
2018. 50,349,150 shares issued and outstanding at December 31, 2019
and 31,943,186 shares issued and outstanding at
December 31, 2018 |
|
5,035 |
|
3,194 |
|
Additional paid-in capital |
|
529,488,474 |
|
331,343,484 |
|
Accumulated other comprehensive income (loss) |
|
28,171 |
|
(56,559 |
) |
Accumulated deficit |
|
(365,905,289 |
) |
(289,088,064 |
) |
Total stockholders’ equity |
|
163,616,391 |
|
42,202,055 |
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity |
|
$ |
186,979,004 |
|
$ |
63,493,570 |
|
Table 2. Stemline Therapeutics, Inc. - Statements of
Operations
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
11,828,984 |
|
$ |
— |
|
$ |
43,216,862 |
|
$ |
— |
|
Income: |
|
|
|
|
|
|
|
|
Grant income |
|
— |
|
|
— |
|
|
— |
|
|
500,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of goods sold |
|
3,152,779 |
|
|
— |
|
|
4,893,339 |
|
|
— |
|
Research and development |
|
10,546,987 |
|
|
12,074,872 |
|
|
50,724,411 |
|
|
47,725,019 |
|
Selling, general and
administrative |
|
16,476,470 |
|
|
14,853,116 |
|
|
66,846,633 |
|
|
39,061,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
30,176,236 |
|
|
26,927,988 |
|
|
122,464,383 |
|
|
86,786,686 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(18,347,252 |
) |
|
(26,927,988 |
) |
|
(79,247,521 |
) |
|
(86,286,686 |
) |
|
|
|
|
|
|
|
|
|
Other expense, net |
|
(44,087 |
) |
|
(3,608 |
) |
|
(47,697 |
) |
|
(7,505 |
) |
Interest expense |
|
(33,920 |
) |
|
(321 |
) |
|
(34,706 6 |
) |
|
(794 |
) |
Interest income |
|
784,255 |
|
|
297,003 |
|
|
2,538,273 |
|
|
1,270,620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income
taxes |
$ |
(17,641,004 |
) |
$ |
(26,634,914 |
) |
$ |
(76,791,651 |
) |
$ |
(85,024,365 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
(39,021 |
) |
|
— |
|
|
(25,574 |
) |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(17,680,025 |
) |
$ |
(26,634,914 |
) |
$ |
(76,817,225 |
) |
$ |
(85,024,365 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common
share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
$ |
(0.38 |
) |
$ |
(0.92 |
) |
$ |
(1.83 |
) |
$ |
(2.99 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
46,851,498 |
|
|
29,085,767 |
|
|
42,091,027 |
|
|
28,388,901 |
|
|
|
|
|
|
|
|
|
|
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