STEMLINE THERAPEUTICS INC (STML) SPO
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|Company Name||STEMLINE THERAPEUTICS INC|
|Company Address||750 LEXINGTON AVENUE
NEW YORK, NY 10022
|Employees (as of 11/9/2017)||32|
|State of Inc||DE|
|Fiscal Year End||12/31|
|Shares Over Alloted||0|
|Shareholder Shares Offered||--|
|Lockup Period (days)||180|
|Quiet Period Expiration||3/5/2018|
We estimate that the net proceeds from our issuance and sale of 3,700,000 shares of our common stock in this offering will be approximately $ million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. If the underwriters exercise the option to purchase an additional 555,000 shares of our common stock in full, we estimate that the net proceeds from this offering will be approximately $ million, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds from this offering for (i) clinical, regulatory, manufacturing and, if and when approved, potential commercial activities of SL-401; (ii) clinical development of SL-801 and SL-701; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes such as those set forth below. SL-401. We have completed a pivotal study and are currently advancing SL-401 toward a potential BLA submission for BPDCN. If successful, we plan to commercialize SL-401 in the United States. We are also currently assessing SL-401 in other indications including certain myeloproliferative neoplasms, AML, and multiple myeloma as a single agent and in combination. We also plan to initiate additional clinical trials with SL-401 as a single agent and/or in combination in other cancers in the future. SL-801. We are enrolling patients with advanced solid tumors in a Phase 1 trial, and dose escalation is ongoing. We are also considering a Phase 1 trial in patients with advanced hematological cancers, as well as combination strategies with SL-801 and other agents, at some point in the future. SL-701. We have completed a Phase 2 trial of SL-701in second-line GBM and are following patients for outcomes including survival. We are considering next steps for the program, including conducting addition studies, including larger studies, either as a single agent or in combination studies with other agents, that could be conducted alone or via partnerships. We will continue to be opportunistic and evaluate assets in an effort to expand our clinical and preclinical pipeline via strategic acquisitions and licensing. Any remaining proceeds will be used for general corporate purposes. This expected use of the net proceeds from this offering represents our intentions based upon our current plans and business conditions. The amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our development efforts, the status of and results from clinical trials, as well as any collaborations that we may enter into with third parties for our product candidates, and any unforeseen cash needs. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering. While we do not expect that the net proceeds from this offering and our existing cash, cash equivalents and marketable securities will be sufficient to enable us to fund the completion of development of any product candidates we may develop, we do believe that our existing cash, cash equivalents, short-term investments and long-term investments, after this offering, will be sufficient to cover our cash flow requirements for at least the next two years. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment grade, interest bearing instruments and U.S. government securities.
The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. Additionally, there has been an increase in development of therapeutics targeting ultra orphan and rare oncologic indications, our main area of focus. While we believe that our scientific knowledge, technology, and development experience provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions. Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future. There are several biopharmaceutical companies whose primary focus appears to be developing therapies against CSCs, including Verastem, Inc., OncoMed Pharmaceuticals, Inc., Sumitomo Dainippon Pharma Co. Ltd., Bionomics Limited and Stemcentrx, Inc. (now an AbbVie, Inc., company). There are also several biopharmaceutical companies that do not appear to be primarily focused on CSCs, but may be developing at least one CSC-directed compound. These companies include Astellas Pharma US, Inc., Boehringer Ingelheim GmbH, Geron Corp., GlaxoSmithKline plc, Ignyta, Inc., Macrogenics Inc., Micromet, Inc. (an Amgen, Inc. company), Pfizer Inc., Roche Holding AG, Sanofi U.S. LLC, and others. Additionally, there are a number of companies working to develop new treatments for hematologic cancers, which may compete with SL-401 and SL-801, including AbbVie, Inc., Ambit Biosciences Corporation (now a Daiichi Sankyo company), Amgen, Inc., Astex Pharmaceuticals (now an Otsuka Pharmaceutical company), Celator Pharmaceuticals, Inc., Celgene Corporation, Cellectis, Cyclacel Pharmaceuticals, Inc., Eisai Co. Ltd., Genzyme Corporation (now a Sanofi company), Immunogen, Inc., Janssen Pharmaceutical Companies of Johnson and Johnson, Karyopharm Therapeutics, Inc., Novartis AG, Seattle Genetics, Inc., and Sunesis Pharmaceuticals, Inc., among others. There are also a number of drugs used for the treatment of brain cancer that may compete with SL-701, including, Avastin® (Roche Holding AG), Gliadel® (Eisai Co. Ltd.), and Temodar® (Merck & Co., Inc.). There are a number of companies working to develop brain cancer therapeutics with programs in clinical testing, including Agenus Inc., Bristol-Myers Squibb, Inc., Cortice Biosciences, Inc., Celldex Therapeutics, Inc., CytRx Corporation, GenSpera, Inc., GlaxoSmithKline plc., ImmunoCellular Therapeutics, Ltd., Northwest Biotherapeutics, Inc., Novartis AG, Roche Holding AG and others. Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Small or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. The key competitive factors affecting the success of all of our product candidates, if approved, are likely to be their efficacy, safety, convenience, price, the level of generic competition and the availability of reimbursement from government and other third-party payors. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. Also, if our competitors receive marketing approval for a product for which it has an orphan designation, we may not be able to receive marketing approval for one of our products for the same indication unless it demonstrates clinical superiority to such product. Our ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic products. If our therapeutic product candidates are approved, we expect that they will be priced at a significant premium over any competitive generic products. The most common methods of treating patients with cancer are surgery, radiation and drug therapy, including chemotherapy, hormone therapy and targeted drug therapy. These therapies are numerous and varied in their design, therapeutic application and mechanism of action. As a result, they may provide significant competition for any of our product candidates for which we obtain market approval. In addition to currently marketed oncology therapies, there are also a number of products in late stage clinical development to treat cancer. These products in development may provide efficacy, safety, convenience and other benefits that are not provided by currently marketed therapies. As a result, they may provide significant competition for any of our product candidates for which we obtain market approval. Competition for SL-401 There are a number of companies working to develop new treatments for AML and other hematologic cancers, including Agios, Inc., Ambit Biosciences Corporation (now a Daiichi Sankyo company), Astex Pharmaceuticals (now an Otsuka Pharmaceutical company), Boehringer Ingelheim, Celator Pharmaceuticals, Inc. (now a Jazz Pharmaceuticals company), Celgene Corporation, Cellectis, Cyclacel Pharmaceuticals, Inc., Eisai Co. Ltd., Epizyme, Inc., Genzyme Corporation (now a Sanofi company), Immunogen, Inc., Janssen Pharmaceutical Companies of Johnson and Johnson, Seattle Genetics, Inc., and Sunesis Pharmaceuticals, Inc., among others. Competition for SL-801 Karyopharm Therapeutics is the only company, to our knowledge, that currently has XPO1 inhibitors in clinical development. Karyopharm’s selinexor is being evaluated in a number of clinical trials in both solid and hematologic cancers, with the most advanced clinical programs in AML, multiple myeloma and diffuse large B-Cell lymphoma, or DLBCL. Karyopharm has also advanced a second generation compound, KPT-8602, into clinical trials in relapsed/refractory multiple myeloma. Competition for SL-701 There are a limited number of drugs used for the treatment of brain cancer, including Temodar® (Merck & Co., Inc.), nitrosoureas including Gliadel® (Eisai Co., Inc.), and Avastin® (Roche Holding AG). There are a number of companies working to develop brain cancer therapeutics with programs in clinical testing including Agenus Inc., Bristol-Myers Squibb, Inc., Cortice Biosciences, Inc., Celldex Therapeutics, Inc., CytRx Corporation, GenSpera, Inc., GlaxoSmithKline plc., ImmunoCellular Therapeutics, Ltd., Northwest Biotherapeutics, Inc., Novartis AG, Roche Holding AG and others.
We are a clinical stage biopharmaceutical company focused on discovering, acquiring, developing and potentially commercializing innovative oncology therapeutics that target difficult to treat cancers. We are currently developing three clinical stage product candidates: SL-401, SL-801 and
SL-701. SL-401 SL-401 is a targeted therapy directed to the interleukin-3 receptor, or IL-3R (CD123), a target present on a wide range of malignancies. A pivotal Phase 2 trial, comprised of 3 Stages, has completed enrollment of patients with blastic plasmacytoid dendritic cell neoplasm, or BPDCN. SL-401 is also being assessed in additional indications including in Phase 1/2 trials of patients with 1) certain myeloproliferative neoplasms, or MPN, focused on chronic myelomonocytic leukemia, or CMML, and myelofibrosis; 2) acute myeloid leukemia, or AML, in complete remission, or CR, with minimal residual disease, or MRD; and 3) relapsed/refractory multiple myeloma in combination with other agents. Factors that may impact next steps for SL-401 in these additional indications include enrollment trends, adverse events, safety and efficacy results, regulatory, competitive and other considerations. SL-401 was granted Breakthrough Therapy Designation, or BTD, by the U.S. Food and Drug Administration, or FDA, for BPDCN in August 2016. The FDA awarded Orphan Drug designation to SL-401 for the treatment of AML in February 2011 and for BPDCN in June 2013. The European Medicines Agency, or EMA, awarded Orphan Drug Designation to SL-401 for the treatment of AML in October 2015 and for BPDCN in November 2015. The pivotal Phase 2 trial of SL-401 in BPDCN is a multicenter, open label, non-randomized, single arm clinical trial. We believe this trial is the largest multicenter prospective study ever conducted in BPDCN. The trial enrolled 45 BPDCN (32 first-line, 13 relapsed/refractory) patients at 7 sites in the U.S. Patients received SL-401 dosed intravenously on days 1-5 of a 21-day cycle. The trial consisted of 3 Stages: Stage 1 (lead-in, dose escalation), Stage 2 (expansion), and Stage 3 (pivotal, confirmatory). To ensure ongoing patient access to SL-401, we are currently enrolling both first-line and relapsed/refractory BPDCN patients in an additional cohort, Stage 4. In December 2017, we presented detailed data from the pivotal trial of SL-401 in BPDCN at the 2017 American Society of Hematology (ASH) Annual Meeting and Exposition, in Atlanta, GA. Based on Stage 1 results in BPDCN patients, SL-401 dosed at 12 mcg/kg/day was selected for use in subsequent Stages. In first-line BPDCN patients who received SL-401 at 12 mcg/kg/day (Stages 1, 2, and 3; n=29), there was a 90% (26/29) overall response rate, or ORR, and a 72% (21/29) rate of CR + CRc + CRi (CR = complete response; CRc = clinical complete response: absence of gross disease with minimal residual skin abnormality; CRi = CR with incomplete hematologic recovery) by investigator assessment. 45% (13/29) of these patients were bridged to stem cell transplant, or SCT, following remission on SL-401. In relapsed/refractory BPDCN patients (all of whom received SL-401 at 12 mcg/kg/day in Stages 1 and 2; n=13), there was a 69% (9/13) ORR, and a 38% (5/13) CR + CRc + CRi rate. Stage 3 of the Phase 2 trial was designed to provide the pivotal, confirmatory evidence of efficacy of SL-401 in BPDCN. In Stage 3, 13 first-line BPDCN patients were enrolled and received SL-401 at 12 mcg/kg/day. Stage 3 met its primary endpoint, with a CR + CRc rate of 54% (7/13) (95% CI: 25.1, 80.8) by investigator assessment. The lower bound of the 95% confidence interval, or CI, of the primary endpoint exceeded the pre-specified 10% rate. ORR was 77% (10/13). 46% (6/13) of patients were bridged to SCT following remission on SL-401. 86% (6/7) of complete responders were relapse-free at 5+ to 8+ months, ongoing. The most common treatment-related adverse events, or TRAEs, with SL-401 in BPDCN (Stages 1, 2, and 3) at 12 mcg/kg/day (n=42) were alanine aminotransferase increase (52%), aspartate aminotransferase increase (50%), hypoalbuminemia (50%), and thrombocytopenia (38%). TRAEs included capillary leak syndrome (19%), which was grade 5 in 2.4% (1/42) of BPDCN patients at 12 mcg/kg/day, 2.6% (4/153) of all patients across all trials at all doses, and 1.7% (2/119) of patients across all trials at 12 mcg/kg/day. SL-401 potential biologics license application (BLA) We believe that the results of the pivotal trial could support pursuing marketing approval, and we plan to include such results as part of a Biologics License Application, or BLA, that seeks U.S. marketing approval. We anticipate such a submission could be completed in the first half of 2018. If successful, we project marketing approval could be attained in the second half of 2018, or soon thereafter. SL-801 SL-801 is a structurally novel, oral, small molecule, reversible inhibitor of Exportin-1, or XPO1, a nuclear transport protein implicated in tumorigenesis. SL-801 has demonstrated preclinical in vitro and in vivo antitumor activity against a wide array of solid and hematologic cancers. SL-801's potential ability to reversibly bind XPO1 may offer the possibility to mitigate side effects and help optimize the therapeutic index. We are currently enrolling patients with advanced solid tumors in a Phase 1 dose escalation trial of single agent SL-801. In September 2017, we presented an update on the SL-801 Phase 1 trial in patients with advanced solid tumors at the European Society of Medical Oncology, or ESMO, Annual Congress 2017 in Madrid, Spain. No dose limiting toxicity, or DLT, or maximum tolerated dose, or MTD, was identified. The most common TRAEs, through six dosing cohorts, include nausea (42%), fatigue (29%), diarrhea (21%), vomiting (17%), and decreased appetite (17%). The most common TRAEs, grade 3, were nausea (4%) and diarrhea (4%). There were no grade 4+ TRAEs. Through these six dosing cohorts, stable disease, or SD, was reported in 38% (9/24) of patients, with tumor shrinkages (range: 3% to 21%) noted in some heavily pre-treated patients. Dose escalation is ongoing, with the eighth dosing cohort currently enrolling. SL-701 SL-701 is an immunotherapy designed to direct the immune system to attack targets present on certain malignancies including brain cancer. SL-701 is comprised of 3 short synthetic peptides that correspond to epitopes of targets including IL-13R†2, EphA2, and survivin; two of these synthetic peptides (IL-13R†2 and survivin) are mutant and believed to enhance immune activity. We completed a Phase 2 trial of SL-701 in adult patients with second-line glioblastoma, or GBM. Several previous investigator-sponsored trials utilizing an earlier version of SL-701 demonstrated clinical activity and manageable safety in adults and children with advanced brain cancers. We subsequently conducted and completed a corporate-sponsored Phase 2 trial, which consisted of 2 stages (Stage 1 and Stage 2). In Stage 1 of this trial (n=46 patients), SL-701 was administered as a single agent, with the immunostimulants GM-CSF and Imiquimod. In Stage 2 of the trial (n=28 patients), SL-701 was administered in combination with bevacizumab, with the immunostimulant poly-ICLC. Both Stages of the trial have completed enrollment and dosing, and patients are being followed for outcomes including survival. In November 2017, we presented data from Stages 1 and 2 at the Society for Neuro-Oncology, or SNO, Annual Meeting in San Francisco, CA. In Stage 1, one patient had a partial response, or PR, of 18+ month duration (ongoing), and there were 15 stable diseases, or SD, 6 of which were at least 5 months duration (range: 5 to 28+ months, ongoing). In Stage 2, 2 patients had complete responses, or CR, and 4 patients had PRs, for an ORR of 21% (6/28). SL-701 was generally well-tolerated. The most common treatment-related adverse events, or TRAEs, were fatigue (22%) and injection site reaction (18%). In Stage 2, the median overall survival, or OS, was 11.6 months with a 48% 12-month OS. In addition, preliminary analyses indicate that SL-701 generated target-specific CD8+ T-cell responses in some patients that experienced clinical benefit, consistent with its mechanism of action. Survival trends and other data will continue to be considered when deciding next steps for the program. These steps may include conducting larger studies, including randomized studies, single arm studies, further combination studies with novel agents, (e.g., checkpoint inhibitors), that could be conducted alone or via partnerships. SL-701 was awarded Orphan Drug designation from the FDA for the treatment of glioma in January 2015. --- We were incorporated under the laws of the State of Delaware in August 2003. Our principal executive office is located at 750 Lexington Avenue, Eleventh Floor, New York, New York 10022 and our telephone number is (646) 502-2311. Our website address is www.stemline.com.
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