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Stemline Therapeutics (STML) Files For $50 M Offering

By Aegis Capital

STML's goal is to maintain and fortify a leadership position in the discovery, acquisition and development of novel oncology therapies that target commercialization of CSC-directed oncology drugs.

STML aims to fortify our leadership position in the anti-CSC space including working to commercialize a CSC-directed oncology drug.

Develop and commercialize SL-401 in multiple hematological cancers. STML plan to complete a pivotal P2b single-arm trial of SL-401 in patients with relapsed or refractory BPDCN in North America and Europe, with overall response rate as the primary endpoint. STML also plan to complete a pivotal randomized P2b clinical trial of SL-401, with OS as the primary endpoint, in AML patients as a third-line treatment. BPDCN and AML are orphan indications, i.e., rare diseases or conditions affecting fewer than 200,000 people in the US, and each represent an unmet medical need. STML further plans to advance SL-401 into a P2 open label trials of additional rare IL-3R-expressing hematologic malignancies including hairy cell leukemia and malignancies and proliferative disorders of mast cell and basophil lineages. STML also plans to evaluate SL-401 in patients with relapsed or refractory multiple myeloma and high risk MDS in P2 trials that can be staged and expanded to serve as platform studies for potential registration.

STML may also evaluate SL-401 in several additional indications, under investigator-sponsored grant-funded studies, including earlier stages of AML (in combination with other agents), advanced CML, as well as non-Hodgkin's and Hodgkin's lymphoma. Accordingly, we believe that SL-401 could be active in multiple hematologic cancer indications thereby representing significant market opportunities for SL-401.

  • Develop and commercialize SL-701 in brain cancer. STML plans to complete P2b clinical trials of SL-701 for the treatment of pediatric patients with brainstem and non-brainstem glioma. STML also plan to complete a P2b clinical trial of SL-701 in adult second-line GBM, which will serve as the foundation for designing a subsequent P3 pivotal trial in this indication.
  • By leverage proprietary drug discovery platform, StemScreen®, to identify new therapeutics. STML intend to utilize proprietary discovery platform to identify new CSC-targeted drug candidates. STML may conduct some of these efforts internally and/or leverage our platform to engage in strategic collaborations. To date, STML has utilized StemScreen® to identify a number of drug candidates.

The Bottom Line: Investor demand for shares of Stemline Therapeutics (NASDAQ: STML) seems to be picking up tremendously, as the stock rallied 13.3% higher yesterday to reach a new high of $16.49 per share in yesterday's trading (May 1st, 2013). This represents a 65% premium over its IPO price of $10.00 per share, and shows that there has been significant investment interest from the market since January 2013. Through the public offering, Stemline collected $38.15 M in proceeds. Based on the statements of CEO Dr. Ivan Bergstein, this should provide the company with the funds needed to meet the next key milestones for its SL-401 and SL-701 development programs.

STML closed at $14.96 0n 5/3/13 and has 3.44 M shares outstanding and a float of 2.09 M. So, why … not at this price which will suffer a little by dilution. STML is already DOWN -$0.62 or -4.14% to $14.34 - look for it to even out at $14.00.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.