Stemline Therapeutics Reports First Quarter 2017 Financial Results
May 10 2017 - 5:13PM
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 March 31, 2017. 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)
- During the quarter, we announced completion of enrollment in
the Stage 3 cohort of the Phase 2 trial. Stage 3 enrolled 13
patients, and statistical analysis will be conducted on evaluable
first-line BPDCN patients.
- Depending on the data from the trial, we plan to use the
results generated, along with other relevant data, to support the
potential filing of a Biologics License Application (BLA) for
approval in BPDCN. A possible BLA filing could begin in 4Q17 or
1Q18.
- To ensure ongoing patient access to SL-401, we are enrolling
both first-line and relapsed/refractory BPDCN patients under the
current protocol in a Stage 4 cohort.
- We plan to provide an update on Stage 1 and 2 patients mid-year
at an upcoming hematology-focused medical conference and on Stage 3
patients in the second half of the year.
Additional Clinical Trials
- Clinical trials evaluating SL-401 are ongoing in additional
indications including certain myeloproliferative neoplasms (MPN),
acute myeloid leukemia (AML) in complete remission with minimal
residual disease, and relapsed/refractory multiple myeloma, and we
expect to provide updates on these studies later this year and into
next year.
- SL-801 is being evaluated in a Phase 1 dose escalation trial of
advanced solid tumor patients, and we recently opened the sixth
dosing cohort. SL-701 has completed dosing in a Phase 2 trial in
second-line glioblastoma. Updates from both of these studies are
expected later this year and into next year.
First Quarter 2017 Financial Results
ReviewStemline ended the first quarter of 2017 with $105.8
million in cash, cash equivalents and investments, as compared to
$67.6 million as of December 31, 2016, which reflects a cash
increase of $38.2 million for the quarter. The $38.2 million
increase in cash represents the $48.2 million in net cash proceeds
received from the company’s follow-on public offering during
January 2017 offset by a $10.0 million cash burn for operating
activities during the first quarter 2017. The company ended the
first quarter of 2017 with 25.1 million shares outstanding.
For the first quarter of 2017, Stemline had a net loss of $14.6
million, or $0.67 per share, compared with a net loss of $9.0
million, or $0.51 per share, for the same period in 2016.
Research and development expenses were $9.6 million for the
first quarter of 2017, which reflects an increase of $3.1 million,
or 47%, compared with $6.5 million for the first quarter of 2016.
The higher costs are primarily driven by an increase of $2.3
million in manufacturing development expenses to support our
upcoming potential BLA filing for SL-401. The manufacturing
development costs include process characterization and process
development work relating to the manufacture of drug substance and
drug product for SL-401. Additionally, we incurred an increase in
costs due to higher compensation expense as a result of increased
headcount. Partially offsetting these higher expenses was a
decrease in clinical trial costs for SL-701 resulting from the
study attaining full patient enrollment during 2016.
General and administrative expenses were $5.4 million for the
first quarter of 2017, which reflects an increase of $2.5 million,
or 87%, compared with $2.9 million for the first quarter of 2016.
The increase in expense was attributable to higher legal and audit
fees of $1.9 million as a result of the class action lawsuits filed
against us arising from our January 2017 follow-on public
offering. Additionally, the higher costs were driven by $0.5
million in commercial-related pre-launch expenses in support of
preparing for a potential product launch of SL-401 in BPDCN if
marketing approval from the FDA is received.
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), has
completed enrollment of patients with blastic plasmacytoid
dendritic cell neoplasm (BPDCN) in the Stage 3 cohort, and patients
continue to be followed. SL-401 has been granted Breakthrough
Therapy Designation (BTD) for the treatment of BPDCN. Additional
Phase 1/2 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 with SL-801, a
novel oral small molecule reversible inhibitor of XPO1, is
enrolling patients with advanced solid tumors. 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 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 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 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
|
|
March
31, 2017(Unaudited) |
|
December 31, 2016 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
57,129,787 |
|
$ |
10,316,064 |
|
Short-term investments |
|
32,524,812 |
|
36,562,900 |
|
Prepaid
expenses and other current assets |
|
516,510 |
|
290,747 |
|
Total
current assets |
|
90,171,109 |
|
47,169,711 |
|
Furniture and fixtures,
net |
|
21,579 |
|
22,531 |
|
Long-term
investments |
|
16,140,705 |
|
20,714,551 |
|
Other Assets |
|
212,305 |
|
212,305 |
|
Total
assets |
|
$ |
106,545,698 |
|
$ |
68,119,098 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
12,535,261 |
|
$ |
9,284,514 |
|
Current
portion of deferred revenue |
|
|
598,798 |
|
|
898,199 |
|
Other
current liabilities |
|
|
71,100 |
|
|
71,100 |
|
Total
current liabilities |
|
13,205,159 |
|
10,253,813 |
|
Other liabilities |
|
124,425 |
|
142,200 |
|
Total
liabilities |
|
13,329,584 |
|
10,396,013 |
|
Stockholders’
equity: |
|
|
|
|
|
Preferred
stock $0.0001 par value, 5,000,000 shares authorized, none issued
and outstanding at March 31, 2017 and December 31, 2016 |
|
— |
|
— |
|
Common
stock $0.0001 par value, 33,750,000 shares authorized at March 31,
2017 and December 31, 2016, 25,096,214 shares issued and
outstanding at March 31, 2017 and 19,219,223 shares
issued and outstanding at December 31, 2016 |
|
2,510 |
|
1,922 |
|
Additional paid-in capital |
|
244,319,102 |
|
193,563,572 |
|
Accumulated other comprehensive loss |
|
(92,192 |
) |
(99,802 |
) |
Accumulated deficit |
|
(151,013,306 |
) |
(135,742,607 |
) |
Total
stockholders’ equity |
|
93,216,114 |
|
57,723,085 |
|
Total liabilities and
stockholders’ equity |
|
$ |
106,545,698 |
|
$ |
68,119,098 |
|
Table 2. Stemline Therapeutics, Inc. - Statements of
Operations (Unaudited)
|
Three Months Ended March 31, |
|
|
2017 |
|
2016 |
|
Revenues: |
|
|
|
|
Grant revenue |
$ |
299,401 |
|
$ |
205,651 |
|
Operating
expenses: |
|
|
|
|
Research and
development |
|
9,620,324 |
|
|
6,532,730 |
|
General and
administrative |
|
5,367,775 |
|
|
2,866,122 |
|
Total operating
expenses |
|
14,988,099 |
|
|
9,398,852 |
|
Loss from
operations |
|
(14,688,698 |
) |
|
(9,193,201 |
) |
Interest income |
|
122,688 |
|
|
144,657 |
|
Net loss |
$ |
(14,566,010 |
) |
$ |
(9,048,544 |
) |
Net loss per common
share: |
|
|
|
|
Basic and Diluted |
$ |
(0.67 |
) |
$ |
(0.51 |
) |
Weighted-average shares
outstanding:Basic and Diluted |
|
21,810,559 |
|
|
17,716,012 |
|
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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