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In The Spotlight: Stemline Therapeutics

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Shares of Stemline Therapeutics Inc. (STML), which have gained an impressive 80% in the last three months, are hovering around their 52 week high mark.

Stemline is a clinical stage biopharmaceutical company developing novel oncology therapeutics that target difficult to treat cancers. The Company has three investigational drugs in clinical development namely, SL-401, SL-801, and SL-701.

SL-401:

SL-401 is under a phase II potentially pivotal trial in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

BPDCN is a rare and aggressive hematologic malignancy of the bone marrow and blood that can affect other organs such as the lymph nodes, spleen, central nervous system, and skin. (Source: DANA-FARBER Cancer Institute).

Last month, the Company reported positive results from the phase II BPDCN trial. The trial consisted of 3 Stages - Stage 1 (lead-in, dose escalation), Stage 2 (expansion), and Stage 3 (pivotal, confirmatory.

Across all stages, lines, and doses in the trial, the complete response rate, i.e., the percentage of patients whose cancer shrunk or disappeared after treatment, was 60% while the overall response rate, i.e., the proportion of patients who had a partial or complete response to the treatment, was 82%.

Detailed results from the phase II trial are expected to be presented at the ASH 2017 Annual Meeting next month.

Stemline is slated to begin submission of its Biologics License Application for SL-401 in blastic plasmacytoid dendritic cell neoplasm this quarter or in the first quarter of 2018.

The potential of SL-401 is also being explored in myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML), and myeloma, and phase 1/2 trials in these indications are ongoing.

SL-701:

SL-701 is under a phase II study in adult patients with second-line glioblastoma multiforme (GBM).

Glioblastoma multiforme is a very aggressive type of brain cancer.

Dosing in the phase II trial of SL-701 has been completed, and an update on the trial is expected to be presented next week at the upcoming Society for Neuro-Oncology (SNO) meeting.

SL-801:

SL-801 is under a phase I trial in patients with advanced solid tumors.

Early data from the ongoing phase I trial were presented in September of this year, and it demonstrated manageable safety and tolerability profile of SL-801. This trial is currently enrolling patients in the eighth dosing cohort.

*Financial Summary:

Cash on hand: $79.9 million
Debt: $0.00
Shares Outstanding: 25.3 million

(*Data as of September 30, 2017).

STML has traded in a range of $5.50 to $14.60 in the last 1 year. The stock closed Friday's (Nov.10, 2017) trading at $14.00, up 5.66%.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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