Stemline Therapeutics Reports First Quarter 2018 Financial Results
May 09 2018 - 4:00PM
Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage
biopharmaceutical company developing novel oncology therapeutics,
announced today financial results for the quarter ended March 31,
2018. The Company also reviewed recent clinical and regulatory
events, and outlined key upcoming milestones:
SL-401 in Blastic Plasmacytoid Dendritic Cell Neoplasm
(BPDCN)
- In April, we announced initiation of a rolling Biologics
License Application (BLA) submission for SL-401, and expect to
complete the rolling submission in 2Q18.
- If our BLA is successful, we anticipate possible U.S. approval
of SL-401 in the 4Q18/1Q19 timeframe.
- In preparation for possible approval, we continue to build out
our pre-launch and commercial activities.
- At the upcoming American Society of Clinical Oncology (ASCO)
annual meeting, we are sponsoring a BPDCN disease awareness booth
designed to continue to build awareness around BPDCN and CD123.
- We anticipate feedback from the European Medicines Agency (EMA)
regarding a potential regulatory filing in Europe, later this
year.
Additional Clinical Trials
- SL-401 is also being evaluated in clinical trials in additional
indications including myeloproliferative neoplasms (MPN) [focused
on chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF)],
acute myeloid leukemia (AML), and multiple myeloma.
- We are evaluating possible registration-directed trial designs
in CMML and MF given the results observed to date. Updates relating
to these programs are expected later this year.
- SL-801: the Phase 1 trial in patients with advanced solid
tumors is ongoing, and dose escalation continues. Data from the
SL-801 trial were selected for presentation at the upcoming ASCO
meeting in June.
- SL-701: the Phase 2 trial in patients with second-line
glioblastoma has completed. Data from the SL-701 trial were
selected for presentation at the upcoming ASCO meeting in
June.
Ivan Bergstein, MD, CEO of Stemline, commented “The initiation
of our rolling BLA submission advances us ever closer to potential
approval and commercialization of SL-401. We continue to build out
our commercial infrastructure, including accelerating efforts to
raise awareness around BPDCN and CD123. In parallel, we continue to
pursue SL-401 in other CD123 positive malignancies and look forward
to forging additional registrational opportunities. We expect
clinical updates from each of our pipeline candidates this year -
all with an eye towards achieving our goal of improving the lives
of patients with cancer and building a leading biopharmaceutical
company.”
First Quarter 2018 Financial Results
ReviewStemline ended the first quarter of 2018 with $106.2
million in cash, cash equivalents and investments, as compared to
$66.2 million as of December 31, 2017, which reflects a cash
increase of $40.0 million for the quarter. The $40.0 million
increase in cash represents the $55.7 million in net cash proceeds
received from the Company’s follow-on public offering during
January 2018 offset by $15.7 million of net cash expenditures
during the first quarter 2018. The Company ended the first quarter
of 2018 with 30.2 million shares outstanding.
For the first quarter of 2018, Stemline had a net loss of $18.4
million, or $0.69 per share, compared with a net loss of $14.6
million, or $0.67 per share, for the same period in 2017.
Research and development expense was $12.7 million for the
quarter ended March 31, 2018, compared with $9.6 million for the
quarter ended March 31, 2017, representing an increase of $3.1
million. The higher costs are primarily driven by an increase in
regulatory and manufacturing expenses in support of our BLA filing
and potential commercialization of SL-401.
General and administrative expense was $5.9 million for the
quarter ended March 31, 2018, compared with $5.4 million for the
quarter ended March 31, 2017, representing an increase of $0.5
million. The increase in expense was due to $0.9 million in higher
pre-launch expenses in support of preparing for a potential
commercialization of SL-401 in BPDCN, if marketing approval from
the FDA is received. Additionally, the higher costs also resulted
from a $0.9 million increase in non-cash stock-based compensation
expense and increased headcount. Partially offsetting the higher
costs was a decrease in legal expenses of $1.3 million.
About BPDCN Please visit the BPDCN disease
awareness booth (#4125) at ASCO 2018 and www.bpdcninfo.com.
About Stemline TherapeuticsStemline
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing novel oncology therapeutics. Stemline is developing
three clinical stage product candidates, SL-401, SL-801, and
SL-701. SL-401 is a targeted therapy directed to the interleukin-3
receptor (CD123) present on a range of malignancies. SL-401 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 rolling Biologics License Application (BLA) submission has been
initiated. SL-401 is also being evaluated in clinical trials in
additional indications including chronic myelomonocytic leukemia
(CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and
myeloma. 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 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
|
|
|
March
31, 2018(Unaudited) |
|
December 31, 2017 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
15,230,838 |
|
$ |
4,795,098 |
|
Short-term investments |
|
84,276,796 |
|
46,924,612 |
|
Prepaid
expenses and other current assets |
|
1,097,642 |
|
469,067 |
|
Total
current assets |
|
100,605,276 |
|
52,188,777 |
|
Property and equipment,
net |
|
124,886 |
|
136,672 |
|
Long-term
investments |
|
6,733,137 |
|
14,468,414 |
|
Other Assets |
|
212,305 |
|
212,305 |
|
Total assets |
|
$ |
107,675,604 |
|
$ |
67,006,168 |
|
Liabilities and stockholders’
equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
19,488,507 |
|
$ |
19,742,087 |
|
Other
current liabilities |
|
|
96,827 |
|
|
96,826 |
|
Total
current liabilities |
|
19,585,334 |
|
19,838,913 |
|
Other liabilities |
|
72,620 |
|
96,826 |
|
Total
liabilities |
|
19,657,954 |
|
19,935,739 |
|
Stockholders’
equity: |
|
|
|
|
|
Preferred
stock $0.0001 par value, 5,000,000 shares authorized, none
issued and outstanding at March 31, 2018 and December
31, 2017 |
|
— |
|
— |
|
Common
stock $0.0001 par value, 53,750,000 shares authorized at March
31, 2018 and December 31, 2017. 30,216,530 shares
issued and outstanding at March 31, 2018 and 25,313,595
shares issued and outstanding at
December 31, 2017 |
|
3,022 |
|
2,531 |
|
Additional paid-in capital |
|
310,857,448 |
|
251,489,546 |
|
Accumulated other comprehensive loss |
|
(150,377 |
) |
(145,958 |
) |
Accumulated deficit |
|
(222,692,443 |
) |
(204,275,690 |
) |
Total
stockholders’ equity |
|
88,017,650 |
|
47,070,429 |
|
Total liabilities and stockholders’ equity |
|
$ |
107,675,604 |
|
$ |
67,006,168 |
|
|
|
|
Table 2. Stemline Therapeutics, Inc. - Statements of
Operations (Unaudited)
|
Three Months Ended March 31, |
|
|
2018 |
|
2017 |
|
Income: |
|
|
|
|
Grant Income |
$ |
— |
|
$ |
299,401 |
|
Operating
expenses: |
|
|
|
|
Research and
development |
|
12,708,058 |
|
|
9,620,324 |
|
General and
administrative |
|
5,938,600 |
|
|
5,367,775 |
|
Total operating
expenses |
|
18,646,658 |
|
|
14,988,099 |
|
Loss from
operations |
|
(18,646,658 |
) |
|
(14,688,698 |
) |
Other expense |
|
(3,897 |
) |
|
— |
|
Interest income |
|
233,802 |
|
|
122,688 |
|
Net loss |
$ |
(18,416,753 |
) |
$ |
(14,566,010 |
) |
Net loss per
common share: |
|
|
|
|
Basic and Diluted |
$ |
(0.69 |
) |
$ |
(0.67 |
) |
Weighted-average
shares outstanding:Basic and Diluted |
|
26,845,983 |
|
|
21,810,559 |
|
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