Stemline Therapeutics Reports Second Quarter 2017 Financial Results
SL-401 In Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- The SL-401 pivotal Phase 2 trial enrolled 45 BPDCN patients in Stages 1, 2 and 3. Stage 3 was prospectively designed to support potential registration.
- During the quarter, we presented updated data from Stages 1 and 2 of the Phase 2 trial at the 22nd
Congressof the European Hematology Association(EHA) in Madrid, Spain.
- Analysis of Phase 2 data, inclusive of Stage 3, is ongoing and we remain on track to announce top-line results in 2H17. We are also targeting a medical conference to present more detailed results later this year.
- To ensure ongoing patient access to SL-401, we are enrolling both first-line and relapsed/refractory BPDCN patients in an additional cohort.
- Depending on the data from the trial, we plan to use the results generated, along with other relevant data, to support the filing of a Biologics License Application (BLA) for approval in BPDCN. We continue to anticipate a possible BLA filing could begin in 4Q17 or 1Q18.
Additional Clinical Trials
- Clinical trials evaluating SL-401 are ongoing in additional indications including certain myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML), and multiple myeloma, as a single agent or in combination with other agents. We expect to provide updates on these studies later this year and into next year.
- SL-801, a novel XPO1 inhibitor, is being evaluated in a Phase 1 trial of patients with advanced solid tumors. SL-701 has completed dosing in a Phase 2 trial of patients with second-line glioblastoma. We are targeting medical conferences for updates on both of these studies later this year.
Second Quarter 2017 Financial Results Review
Stemline ended the second quarter of 2017 with
For the second quarter of 2017, Stemline had a net loss of
Research and development expenses were
General and administrative expenses were
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
|June 30, 2017
|December 31, 2016|
|Cash and cash equivalents||$||8,549,890||$||10,316,064|
|Prepaid expenses and other current assets||471,880||290,747|
|Total current assets||64,557,870||47,169,711|
|Furniture and fixtures, net||45,773||22,531|
Liabilities and stockholders’ equity
|Accounts payable and accrued expenses||$||13,523,018||$||9,284,514|
|Current portion of deferred grant revenue||299,397||898,199|
|Other current liabilities||71,100||71,100|
|Total current liabilities||13,893,515||10,253,813|
|Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at June 30, 2017 and December 31, 2016||—||—|
|Common stock $0.0001 par value, 53,750,000 shares authorized at June 30, 2017 and 33,750,000 shares authorized at December 31, 2016. 25,180,024 shares issued and outstanding at June 30, 2017 and 19,219,223 shares issued and outstanding at December 31, 2016||2,518||1,922|
|Additional paid-in capital||246,562,007||193,563,572|
|Accumulated other comprehensive loss||(120,897||)||(99,802||)|
|Total stockholders’ equity||79,973,386||57,723,085|
|Total liabilities and stockholders’ equity||$||93,973,551||$||68,119,098|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||11,479,030||6,875,970||21,099,354||13,408,700|
|General and administrative||4,480,630||2,860,639||9,848,406||5,726,761|
|Total operating expenses||15,959,660||9,736,609||30,947,760||19,135,461|
|Loss from operations||(15,660,259||)||(9,499,708||)||(30,348,958||)||(18,692,909||)|
|Net loss before income taxes||(15,456,936||)||(9,348,899||)||(30,022,946||)||(18,397,443||)|
|Income tax benefit||—||26,756||—||26,756|
|Net loss per common share:|
|Basic and Diluted||$||(0.66||)||$||(0.52||)||$||(1.33||)||$||(1.03||)|
|Weighted-average shares outstanding:
Basic and Diluted
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Stemline Therapeutics, Inc. 750 Lexington AvenueEleventh Floor New York, NY10022 Tel: 646-502-2307 Email: email@example.com