Stemline Therapeutics Reports Fourth Quarter 2016 Financial Results
17 March 2017 - 10:26AM
Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage
biopharmaceutical company developing novel therapeutics for
oncology indications of unmet medical need, announced today
financial results for the quarter ended December 31, 2016. The
company also reviewed clinical and regulatory events from the past
quarter, and outlined key upcoming milestones:
SL-401 In Blastic Plasmacytoid Dendritic
Cell Neoplasm (BPDCN)
- SL-401 Phase 2 clinical trial results in patients with blastic
plasmacytoid dendritic cell neoplasm (BPDCN) delivered as an oral
presentation at the 2016 American Society of Hematology (ASH)
annual meeting.
- After receipt of breakthrough therapy designation in 3Q16,
Stemline had a successful meeting with the U.S. Food and Drug
Administration (FDA) resulting in a defined registration pathway
for possible full approval in first-line BPDCN.- Stemline is
currently enrolling patients in a new cohort (Stage 3) that is
expected to enroll approximately 8-12 first-line BPDCN patients.-
Completion of enrollment of the Stage 3 cohort expected this
quarter. We plan to provide clinical results from this cohort in
the second half of this year.
Additional Clinical Trials
- SL-401 is being clinically evaluated in several additional
indications including certain high-risk myeloproliferative
neoplasms (MPN), acute myeloid leukemia (AML) in complete remission
with minimal residual disease, and with relapsed/refractory
multiple myeloma. SL-801 is being evaluated in a Phase 1 dose
escalation trial of advanced solid tumor patients. SL-701 has
completed dosing in a Phase 2 trial in second-line glioblastoma.
Updates from these studies are expected this year.
Fourth Quarter 2016 Financial Results
ReviewStemline ended the fourth quarter of 2016 with $67.6
million in cash, cash equivalents and investments, as compared to
$74.3 million as of September 30, 2016, which reflects a cash burn
of $6.7 million for the quarter. Subsequent to year end 2016,
Stemline completed a follow-on public offering during January 2017
raising $48.2 million in net cash proceeds bringing total cash,
cash equivalents and investments to approximately $110.0 million as
of March 16, 2017.
For the fourth quarter of 2016, Stemline had a net
loss of $10.0 million, or $0.56 per share, compared with a net loss
of $10.2 million, or $0.58 per share, for the same period in
2015.
Research and development expenses were $7.3 million
for the fourth quarter of 2016, which reflects a decrease of $0.6
million, or 8%, compared with $7.9 million for the fourth quarter
of 2015. The lower costs reflect a one-time payroll-related
expense in 2015 partially offset by higher non-cash stock based
compensation expense in 2016.
General and administrative expenses were $3.1
million for the fourth quarter of 2016, which reflects an increase
of $0.5 million, or 19%, compared with $2.6 million for the fourth
quarter of 2015. The increase in costs was primarily attributable
to higher non-cash stock based compensation expense and the
commencement of building infrastructure to support a potential
commercial launch of SL-401 for BPDCN.
About Stemline Therapeutics
Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical
company developing novel therapeutics for oncology indications of
unmet medical need. A Phase 2 pivotal trial with SL-401, a targeted
therapy directed to the interleukin-3 receptor (CD123), is
enrolling patients with blastic plasmacytoid dendritic cell
neoplasm (BPDCN), an indication for which SL-401 has been granted
Breakthrough Therapy Designation (BTD). Additional Phase 2 trials
with SL-401 are enrolling patients with other malignancies
including high-risk myeloproliferative neoplasms (MPN) and acute
myeloid leukemia (AML) in remission with minimal residual disease
(MRD). A Phase 1/2 trial of SL-401 in combination with pomalidomide
is enrolling patients with relapsed/refractory multiple myeloma. A
Phase 1 dose escalation trial is enrolling patients with advanced
tumors with SL-801, a novel oral small molecule reversible
inhibitor of XPO1. A Phase 2 trial with SL-701, an immunotherapy
designed to activate the immune system to attack tumors, has
completed dosing and patients with second-line glioblastoma are
being followed for survival.
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 clinical trials and preclinical studies for our
product candidates, including site initiation, internal 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
ultimately does not 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 Securities and Exchange Commission. 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.
Table 1. Stemline Therapeutics, Inc. - Balance
Sheets |
|
|
|
December 31, 2016 |
|
December 31, 2015 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
10,316,064 |
|
$ |
13,376,196 |
|
Short-term investments |
|
36,562,900 |
|
32,663,245 |
|
Prepaid
expenses and other current assets |
|
290,747 |
|
651,889 |
|
Total
current assets |
|
47,169,711 |
|
46,691,330 |
|
Furniture and fixtures,
net |
|
22,531 |
|
95,661 |
|
Long-term
investments |
|
20,714,551 |
|
51,428,632 |
|
Other Assets |
|
212,305 |
|
— |
|
Total
assets |
|
$ |
68,119,098 |
|
$ |
98,215,623 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
9,284,514 |
|
$ |
8,632,873 |
|
Current
portion of deferred grant revenue |
|
|
898,199 |
|
|
822,604 |
|
Other
current liabilities |
|
|
71,100 |
|
|
— |
|
Total
current liabilities |
|
10,253,813 |
|
9,455,477 |
|
Deferred grant revenue,
net of current portion |
|
— |
|
616,949 |
|
Other liabilities |
|
142,200 |
|
31,241 |
|
Total
liabilities |
|
10,396,013 |
|
10,103,667 |
|
Stockholders’
equity: |
|
|
|
|
|
Preferred
stock $0.0001 par value, 5,000,000 shares authorized, none issued
and outstanding at December 31, 2016 and 2015 |
|
— |
|
— |
|
Common
stock $0.0001 par value, 33,750,000 shares authorized at December
31, 2016 and 2015, 19,219,223 shares issued and
outstanding at December 31, 2016 and 18,235,020 shares
issued and outstanding at December 31, 2015 |
|
1,922 |
|
1,825 |
|
Additional paid-in capital |
|
193,563,572 |
|
185,703,423 |
|
Accumulated other comprehensive loss |
|
(99,802 |
) |
(153,690 |
) |
Accumulated deficit |
|
(135,742,607 |
) |
(97,439,602 |
) |
Total
stockholders’ equity |
|
57,723,085 |
|
88,111,956 |
|
Total
liabilities and stockholders’ equity |
|
$ |
68,119,098 |
|
$ |
98,215,623 |
|
Table 2. Stemline Therapeutics, Inc. - Statements of
Operations |
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Revenues: |
|
|
|
|
|
|
|
|
Grant revenue |
$ |
299,401 |
|
$ |
205,651 |
|
$ |
1,041,354 |
|
$ |
654,160 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
7,284,262 |
|
|
7,882,933 |
|
|
27,869,921 |
|
|
29,458,676 |
|
General and
administrative |
|
3,142,260 |
|
|
2,631,148 |
|
|
12,056,890 |
|
|
8,828,843 |
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
10,426,522 |
|
|
10,514,081 |
|
|
39,926,811 |
|
|
38,287,519 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(10,127,121 |
) |
|
(10,308,430 |
) |
|
(38,885,457 |
) |
|
(37,633,359 |
) |
|
|
|
|
|
|
|
|
|
Other (expense)
income |
|
(299 |
) |
|
— |
|
|
11,438 |
|
|
1,609 |
|
Interest income |
|
128,606 |
|
|
128,824 |
|
|
545,718 |
|
|
387,889 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income
taxes |
$ |
(9,998,814 |
) |
$ |
(10,179,606 |
) |
$ |
(38,328,301 |
) |
$ |
(37,243,861 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax (expense)
benefit |
|
(10,282 |
) |
|
— |
|
|
25,296 |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(10,009,096 |
) |
$ |
(10,179,606 |
) |
$ |
(38,303,005 |
) |
$ |
(37,243,861 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
$ |
(0.56 |
) |
$ |
(0.58 |
) |
$ |
(2.15 |
) |
$ |
(2.15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
17,885,113 |
|
|
17,562,559 |
|
|
17,804,681 |
|
|
17,289,021 |
|
|
|
|
|
|
|
|
|
|
Contact
Investor Relations
Stemline Therapeutics, Inc.
750 Lexington Avenue
Eleventh Floor
New York, NY 10022
Tel: 646-502-2307
Email: investorrelations@stemline.com
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