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Wired News – Stemline Therapeutics Initiates Rolling BLA Submission for SL-401

Stock Monitor: Cyclacel Pharma Post Earnings Reporting

LONDON, UK / ACCESSWIRE / April 09, 2018 / Active-Investors.com has just released a free research report on Stemline Therapeutics, Inc. (NASDAQ: STML) ("Stemline"). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=STML as the Company's latest news hit the wire. On April 05, 2018, the Company, which is a clinical-stage biopharmaceutical organization developing novel oncology therapeutics, declared that it has started its rolling submission of a Biologics License Application (BLA) for SL-401 to the US Food and Drug Administration (FDA). Register today and get access to over 1000 Free Research Reports by joining our site below:

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Active-Investors.com is currently working on the research report for Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC), which also belongs to the Healthcare sector as the Company Stemline Therapeutics. Do not miss out and become a member today for free to access this upcoming report at:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Stemline Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/?symbol=STML

About SL-401

SL-401 is one of the clinical stage product candidates of Stemline. 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), wherein it met its primary endpoint. Moreover, the FDA has granted a Breakthrough Therapy Designation (BTD) to SL-401 in BPDCN.

Besides, the product candidate is also being evaluated in clinical trials in additional indications such as chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and myeloma.

A Major Milestone for SL-401

Ivan Bergstein, MD, Chief Executive Officer (CEO) of Stemline, believes that the start of the rolling BLA submission is a significant milestone for the Company and the BPDCN patient community.

If SL-401 gets approved, it would be the first-drug ever approved for BPDCN and would have a transformative impact on the lives of patients suffering with this malignant disease. Looking forward, the Company intends to continue its clinical, regulatory, manufacturing, and commercial work to bring SL-401 to patients as soon as possible.

Stemline Reported Fourth Quarter 2017 Results

Stemline reported its financial results on March 16, 2018, for the fourth quarter and full fiscal year ended December 31, 2017.

  • The Company had a net loss of $21.75 million, or $0.93 loss per share, in Q4 FY17, compared to a net loss of $10.0 million, or $0.56 loss per share, in the same period of 2016.

  • The Company's operating expenses were $21.94 million in the reported quarter versus $10.43 million in the previous year's comparable quarter. The Company's research and development (R&D) expenses advanced 129.61% to $16.73 million y-o-y, and its general and administrative (G&A) expenses increased 65.91% to $5.21 million y-o-y in Q4 FY17.

  • Stemline had cash, cash equivalents, and investments of $66.2 million, 17.15% lower than $79.9 million as of September 30, 2017. The Company incurred a total capital expenditure of $13.7 million in the quarter under review.

  • During January 2018, Stemline completed a follow-on public offering, raising $55.5 million in net cash proceeds, which brought its total cash, cash equivalents, and investments to approximately $106.8 million as on March 16, 2018.

  • For the full fiscal year ended December 31, 2017, Stemline generated revenues of $0.9 million, 13.75% lower than $1.04 million in FY16. The Company incurred a net loss of $67.83 million in the reported year, 77.08% higher than $38.30 million in FY16.

Stock Performance Snapshot

April 06, 2018 - At Friday's closing bell, Stemline Therapeutics' stock was slightly down 0.66%, ending the trading session at $15.10.

Volume traded for the day: 212.28 thousand shares.

Stock performance in the previous six-month period – up 31.30%; and past twelve-month period – up 94.84%

After last Friday's close, Stemline Therapeutics' market cap was at $451.79 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.

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