Stemline Therapeutics Reports Third Quarter 2018 Financial Results
November 08 2018 - 4:01PM
Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical
company focused on the development and potential commercialization
of novel oncology therapeutics, announced today financial results
for the quarter ended September 30, 2018. The Company also reviewed
recent clinical and regulatory events, and outlined key upcoming
milestones:
ELZONRIS – Potential Approval and Pre-Commercial
Activities
- The FDA accepted, for filing, the Company’s Biologics License
Application (BLA) for ELZONRISTM (tagraxofusp; SL-401) for the
treatment of patients with blastic plasmacytoid dendritic cell
neoplasm (BPDCN). The FDA also granted Priority Review for the BLA
and set a target action date of February 21, 2019, under the
Prescription Drug User Fee Act (PDUFA).
- In preparation for potential US approval, we continue to build
out our pre-launch activities. These efforts include ramping up our
disease awareness campaign targeting key stakeholders including
hematologist-oncologists, dermatologists, and pathologists.
- During the quarter, we conducted meetings with our assigned
Rapporteurs and the European Medicines Agency (EMA). Based on
feedback from these meetings, we plan to submit a Marketing
Authorization Application (MAA) to the EMA for ELZONRIS in the
first quarter of 2019 seeking marketing approval in Europe.
ELZONRIS – Market Expansion Efforts
- ELZONRIS is being evaluated in clinical trials in additional
indications, with a focus on chronic myelomonocytic leukemia (CMML)
and myelofibrosis (MF).
- Based on the clinical results observed in CMML and MF thus far,
we are finalizing registrational plans in these indications. We
plan to seek regulatory advice in early 2019 with the goal of
initiating pivotal trials, or cohorts, to follow. Ahead of this,
the ongoing trial continues to enroll CMML and MF patients, and
periodic updates at upcoming conferences will be provided.
ASH Conference
- At the upcoming American Society of Hematology (ASH) conference
in December, ELZONRIS data were selected for four presentations,
including an oral presentation. Presentations include results of
the BPDCN pivotal trial and updated clinical trial data in patients
with chronic myelomonocytic leukemia (CMML) and myelofibrosis
(MF).
- Additionally, we expect to have a robust clinical, medical
affairs and pre-commercial presence at ASH, including hosting an
investor/analyst event on December 3rd.
SL-801
- In October, 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.
- Patient enrollment and dose escalation continues. We expect to
provide further updates at upcoming conferences.
SL-701
- In October, data from the Phase 2 trial of SL-701 in patients
with second-line glioblastoma (GBM) were delivered via oral
presentation at the European Society of Medical Oncology (ESMO)
Annual Congress 2018.
- Discussions around next steps to unlock potential value from
the program are ongoing, and we expect to provide further updates
at upcoming conferences.
Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented
“This is an extremely exciting time for Stemline, as we gear up for
the possible approval and near-term launch of ELZONRIS for BPDCN.
We have nearly completed the full build-out of our U.S. sales force
and commercial infrastructure in preparation for potential launch
of ELZONRIS. In parallel, we continue to generate very promising
clinical data in CMML and MF, additional areas of unmet medical
need. Overall, the ability to effectively target CD123 with an
acceptable safety profile we believe opens up significant
developmental and commercial opportunities for Stemline.”
Third Quarter 2018 Financial Results Review
Stemline ended the third quarter of 2018 with $78.5 million in
cash, cash equivalents and investments, representing cash use of
$18.6 million in the third quarter. The Company ended the third
quarter of 2018 with 31.7 million shares outstanding. For the third
quarter of 2018, Stemline had a net loss of $21.0 million, or $0.73
per share, compared with a net loss of $16.1 million, or $0.68 per
share, for the same period in 2017.
Research and development expenses were $11.8 million for the
quarter ended September 30, 2018, compared with $12.4 million for
the quarter ended September 30, 2017.
General and administrative expenses were $9.6 million for the
quarter ended September 30, 2018, compared with $4.2 million for
the quarter ended September 30, 2017, representing an increase of
$5.4 million. The higher expenses were primarily attributed to a
$4.6 million increase in pre-launch expenses to support a potential
commercialization of ELZONRIS in BPDCN, if marketing approval from
the FDA is obtained. Additionally, the higher expense was also due
to an increase in non-cash stock-based compensation and increased
headcount.
About BPDCNPlease visit the BPDCN disease
awareness booth (#205) at ASH 2018, and the BPDCN disease awareness
website at www.bpdcninfo.com.
About Stemline TherapeuticsStemline
Therapeutics, Inc. is a biopharmaceutical company focused on the
development and potential commercialization of novel oncology
therapeutics. Stemline is developing three clinical stage product
candidates, ELZONRISTM (tagraxofusp; SL-401), SL-801, and SL-701.
ELZONRIS is a targeted therapy directed to the interleukin-3
receptor (CD123) present on a range of malignancies. ELZONRIS has
completed a pivotal trial in blastic plasmacytoid dendritic cell
neoplasm (BPDCN), for which it was granted breakthrough therapy
designation (BTD). The pivotal trial met its primary endpoint, and
a Biologics License Application (BLA) has been accepted for filing
and granted Priority Review by the FDA. ELZONRIS is also being
evaluated in clinical trials in additional indications including
chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and
others. SL-801 is a novel oral small molecule reversible inhibitor
of XPO1 that is currently in a Phase 1 trial of patients with
advanced solid tumors; dose escalation is ongoing. SL-701, an
immunotherapeutic, has completed a Phase 2 trial in patients with
second-line glioblastoma; data and next steps for the program are
being evaluated.
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 and timing
of our BLA submission to the FDA; 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 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; our plans to develop and commercialize our product
candidates; market acceptance of our products; reimbursement
available for our products; our available cash and investments; our
ability to obtain and maintain intellectual property protection for
our product candidates; our ability to manufacture; the performance
of third-party 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.
ContactInvestor RelationsStemline Therapeutics,
Inc.750 Lexington AvenueEleventh FloorNew York, NY 10022Tel:
646-502-2307Email: investorrelations@stemline.com
Table 1. Stemline Therapeutics, Inc. -
Balance Sheets
|
|
September 30, 2018
(Unaudited) |
|
December 31, 2017 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,677,741 |
|
$ |
4,795,098 |
|
Short-term investments |
|
66,856,499 |
|
46,924,612 |
|
Prepaid expenses and other current
assets |
|
1,996,235 |
|
469,067 |
|
Total current assets |
|
80,530,475 |
|
52,188,777 |
|
Property and equipment, net |
|
221,820 |
|
136,672 |
|
Long-term investments |
|
— |
|
14,468,414 |
|
Other Assets |
|
212,305 |
|
212,305 |
|
Total assets |
|
$ |
80,964,600 |
|
$ |
67,006,168 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
17,202,090 |
|
$ |
19,742,087 |
|
Other current liabilities |
|
|
133,170 |
|
|
96,826 |
|
Total current liabilities |
|
17,335,260 |
|
19,838,913 |
|
Other liabilities |
|
91,174 |
|
96,826 |
|
Total liabilities |
|
17,426,434 |
|
19,935,739 |
|
Commitments and ContingenciesStockholders’ equity: |
|
|
|
|
|
Preferred stock $0.0001 par value, 5,000,000 shares
authorized, none issued and outstanding at September 30, 2018 and
December 31, 2017 |
|
— |
|
— |
|
Common stock $0.0001 par value, 53,750,000 shares
authorized at September 30, 2018 and December 31,
2017. 31,671,552 shares issued and outstanding at
September 30, 2018 and 25,313,595 shares
issued and outstanding at December 31,
2017 |
|
3,167 |
|
2,531 |
|
Additional paid-in capital |
|
326,084,695 |
|
251,489,546 |
|
Accumulated other comprehensive loss |
|
(96,546 |
) |
(145,958 |
) |
Accumulated deficit |
|
(262,453,150 |
) |
(204,275,690 |
) |
Total stockholders’ equity |
|
63,538,166 |
|
47,070,429 |
|
Total liabilities and stockholders’
equity |
|
$ |
80,964,600 |
|
$ |
67,006,168 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Table 2. Stemline Therapeutics, Inc. - Statements of
Operations (Unaudited)
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
|
2017 |
|
Income: |
|
|
|
|
|
|
|
|
Grant income |
$ |
— |
|
$ |
299,397 |
|
$ |
500,000 |
|
|
$ |
898,199 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
11,758,025 |
|
|
12,417,652 |
|
|
35,650,147 |
|
|
|
33,517,006 |
|
General and
administrative |
|
9,647,336 |
|
|
4,152,449 |
|
|
24,208,551 |
|
|
|
14,000,854 |
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
21,405,361 |
|
|
16,570,101 |
|
|
59,858,698 |
|
|
|
47,517,860 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(21,405,361 |
) |
|
(16,270,704 |
) |
|
(59,358,698 |
) |
|
|
(46,619,661 |
) |
Other income |
|
— |
|
|
381 |
|
|
— |
|
|
|
381 |
|
Other expense |
|
— |
|
|
(3,566 |
) |
|
(3,897 |
) |
|
|
(3,566 |
) |
Interest expense |
|
(350 |
) |
|
— |
|
|
(473 |
) |
|
|
— |
|
Interest income |
|
361,715 |
|
|
217,742 |
|
|
973,617 |
|
|
|
543,753 |
|
Net loss |
$ |
(21,043,996 |
) |
$ |
(16,056,147 |
) |
$ |
(58,389,451 |
) |
|
$ |
(46,079,093 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
$ |
(0.73 |
) |
$ |
(0.68 |
) |
$ |
(2.07 |
) |
|
$ |
(2.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding: Basic and Diluted |
|
29,018,507 |
|
|
23,464,505 |
|
|
28,253,750 |
|
|
|
22,901,883 |
|
|
|
|
|
|
|
|
|
|
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