Stemline Therapeutics Reports Second Quarter 2018 Financial Results
ELZONRIS™ (SL-401, tagraxofusp) – BLA submission completed
- We completed submission of a rolling Biologics License Application (BLA) to the
U.S. Food and Drug Administration (FDA ) for ELZONRIS, which has been granted breakthrough therapy designation (BTD), for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). If successful, we anticipate acceptance of our BLA within 60 days of submission (i.e. in the coming weeks) and potential U.S. marketing approval by 1Q19, or possibly sooner. - Data from our pivotal trial in patients with BPDCN was the subject of an oral presentation at the 23rd
Congress of theEuropean Hematology Association (EHA) inStockholm, Sweden . - We anticipate feedback from the
European Medicines Agency (EMA) later this year regarding a potential ELZONRIS regulatory filing inEurope . - In preparation for potential marketing approval, we continue to build out our pre-launch and commercial activities, including our disease awareness campaign targeting key stakeholders including hematologist-oncologists, dermatologists, and pathologists.
ELZONRIS – Other potential indications
- ELZONRIS is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF).
- Clinical data from ongoing trials in patients with CMML and MF were selected for presentation at EHA in June.
- In relapsed/refractory CMML (n=16 patients), ELZONRIS demonstrated 100% (8/8) spleen responses in evaluable patients with baseline splenomegaly by physical exam and 2 bone marrow complete responses (BMCRs), coupled with a tolerable safety profile. Given the results observed to date, we are currently formulating registrational trial designs.
- In relapsed/refractory MF (n=15 patients), ELZONRIS demonstrated 50% (6/12) spleen responses in evaluable patients with baseline splenomegaly (>5 cm palpable below the costal margin by physical exam), coupled with a tolerable safety profile. Given the results observed to date, we are currently evaluating next steps including possible registrational trial designs.
- In relapsed/refractory CMML (n=16 patients), ELZONRIS demonstrated 100% (8/8) spleen responses in evaluable patients with baseline splenomegaly by physical exam and 2 bone marrow complete responses (BMCRs), coupled with a tolerable safety profile. Given the results observed to date, we are currently formulating registrational trial designs.
SL-801
- Data from the ongoing Phase 1 trial of SL-801 in patients with advanced solid tumors were presented at the 2018
American Society of Clinical Oncology (ASCO ) annual meeting in June. Patient enrollment and dose escalation continues.
SL-701
- Data from the Phase 2 trial of SL-701 in patients with second-line glioblastoma (GBM) were presented at the 2018
ASCO meeting in June. Notably, there were long-term (>12 month) overall survivors in the SL-701+bevacizumab cohort which consisted primarily of patients who demonstrated an elevated immune response (i.e. potentially representing an “immunocompetent” population). Further analyses, including registration-directed designs are ongoing.
Second Quarter 2018 Financial Results Review
Stemline ended the second quarter of 2018 with
Research and development expense was
General and administrative expense was
About BPDCN
Please visit the BPDCN disease awareness website: www.bpdcninfo.com.
About
Forward-Looking Statements
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 BLA submission to the
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Email: investorrelations@stemline.com
Table 1.
June 30, 2018 (Unaudited) |
December 31, 2017 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 16,909,400 | $ | 4,795,098 | |||
Short-term investments | 79,232,550 | 46,924,612 | |||||
Prepaid expenses and other current assets | 2,221,982 | 469,067 | |||||
Total current assets | 98,363,932 | 52,188,777 | |||||
Property and equipment, net | 142,137 | 136,672 | |||||
Long-term investments | 992,317 | 14,468,414 | |||||
Other Assets | 212,305 | 212,305 | |||||
Total assets | $ | 99,710,691 | $ | 67,006,168 | |||
Liabilities and stockholders’ equity |
|||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 18,179,418 | $ | 19,742,087 | |||
Other current liabilities | 106,222 | 96,826 | |||||
Total current liabilities | 18,285,640 | 19,838,913 | |||||
Other liabilities | 67,785 | 96,826 | |||||
Total liabilities | 18,353,425 | 19,935,739 | |||||
Stockholders’ equity: | |||||||
Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at June 30, 2018 and December 31, 2017 | — | — | |||||
Common stock $0.0001 par value, 53,750,000 shares authorized at June 30, 2018 and December 31, 2017. 30,917,705 shares issued and outstanding at June 30, 2018 and 25,313,595 shares issued and outstanding at December 31, 2017 |
3,092 | 2,531 | |||||
Additional paid-in capital | 322,886,302 | 251,489,546 | |||||
Accumulated other comprehensive loss | (122,973 | ) | (145,958 | ) | |||
Accumulated deficit | (241,409,155 | ) | (204,275,690 | ) | |||
Total stockholders’ equity | 81,357,266 | 47,070,429 | |||||
Total liabilities and stockholders’ equity | $ | 99,710,691 | $ | 67,006,168 | |||
Table 2.
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2018 |
2017 | 2018 |
2017 |
||||||||||||
Revenues: | |||||||||||||||
Grant income | $ | 500,000 | $ | 299,401 | $ | 500,000 | $ | 598,802 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 11,184,064 | 11,479,030 | 23,892,122 | 21,099,354 | |||||||||||
General and administrative | 8,622,616 | 4,480,630 | 14,561,216 | 9,848,406 | |||||||||||
Total operating expenses | 19,806,680 | 15,959,660 | 38,453,338 | 30,947,760 | |||||||||||
Loss from operations | (19,306,680 | ) | (15,660,259 | ) | (37,953,338 | ) | (30,348,958 | ) | |||||||
Other expense | — | — | (3,897 | ) | — | ||||||||||
Interest expense | (123 | ) | — | (123 | ) | — | |||||||||
Interest income | 378,100 | 203,323 | 611,902 | 326,012 | |||||||||||
Net loss | $ | (18,928,703 | ) | $ | (15,456,936 | ) | $ | (37,345,456 | ) | $ | (30,022,946 | ) | |||
Net loss per common share: | |||||||||||||||
Basic and Diluted | $ | (0.66 | ) | $ | (0.66 | ) | $ | (1.34 | ) | $ | (1.33 | ) | |||
Weighted-average shares outstanding: | |||||||||||||||
Basic and Diluted | 28,567,982 | 23,412,409 | 27,851,707 | 22,615,909 | |||||||||||
Source: Stemline Therapeutics, Inc.