UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


 

FORM 8-K

 


 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): May 10, 2018

 

Stemline Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware
(State or Other Jurisdiction
of Incorporation)

 

001-35619
(Commission File Number)

 

45-0522567
(IRS Employer Identification No.)

 

750 Lexington Avenue

Eleventh Floor

New York, New York 10022

(Address of Principal Executive Offices)

 

(646) 502-2311

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o Written communications pursuant to Rule 425 under the Securities Act.

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act.

 

o Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act.

 

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).   Emerging growth company   x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.    x

 

 

 



 

Item 2.02. Results of Operations and Financial Condition.

 

On May 9, 2018, Stemline Therapeutics, Inc. issued a press release to provide a corporate update and to announce its financial results for the first quarter ended March 31, 2018. A copy of such press release is being furnished as Exhibit 99.1 to this report.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

The following exhibit is furnished herewith:

 

Exhibit
Number

 

Description

 

 

 

99.1

 

Press release issued by Stemline Therapeutics, Inc., dated May 9, 2018.

 

2



 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: May 10, 2018

Stemline Therapeutics, Inc.

 

(Registrant)

 

 

 

 

 

 

By

/s/ Kenneth Hoberman

 

 

Kenneth Hoberman

 

 

Chief Operating Officer

 

3


Exhibit 99.1

 

 

Stemline Therapeutics Reports First Quarter 2018 Financial Results

 

NEW YORK, May 9, 2018 (GLOBE NEWSWIRE) — Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, announced today financial results for the quarter ended March 31, 2018. The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

 

SL-401 in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

 

·                  In April, we announced initiation of a rolling Biologics License Application (BLA) submission for SL-401, and expect to complete the rolling submission in 2Q18.

 

·                  If our BLA is successful, we anticipate possible U.S. approval of SL-401 in the 4Q18/1Q19 timeframe.

 

·                  In preparation for possible approval, we continue to build out our pre-launch and commercial activities.

 

·                  At the upcoming American Society of Clinical Oncology (ASCO) annual meeting, we are sponsoring a BPDCN disease awareness booth designed to continue to build awareness around BPDCN and CD123.

 

·                  We anticipate feedback from the European Medicines Agency (EMA) regarding a potential regulatory filing in Europe, later this year.

 

Additional Clinical Trials

 

·                  SL-401 is also being evaluated in clinical trials in additional indications including myeloproliferative neoplasms (MPN) [focused on chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF)], acute myeloid leukemia (AML), and multiple myeloma.

 

·                  We are evaluating possible registration-directed trial designs in CMML and MF given the results observed to date. Updates relating to these programs are expected later this year.

 

·                  SL-801: the Phase 1 trial in patients with advanced solid tumors is ongoing, and dose escalation continues. Data from the SL-801 trial were selected for presentation at the upcoming ASCO meeting in June.

 

·                  SL-701: the Phase 2 trial in patients with second-line glioblastoma has completed. Data from the SL-701 trial were selected for presentation at the upcoming ASCO meeting in June.

 

Ivan Bergstein, MD, CEO of Stemline, commented “The initiation of our rolling BLA submission advances us ever closer to potential approval and commercialization of SL-401. We continue to build out our commercial infrastructure, including accelerating efforts to raise awareness around BPDCN and CD123. In parallel, we continue to pursue SL-401 in other CD123 positive malignancies and look forward to forging additional registrational opportunities. We expect clinical updates from each of our pipeline candidates this year - all with an eye towards achieving our goal of improving the lives of patients with cancer and building a leading biopharmaceutical company.”

 

First Quarter 2018 Financial Results Review

 

Stemline ended the first quarter of 2018 with $106.2 million in cash, cash equivalents and investments, as compared to $66.2 million as of December 31, 2017, which reflects a cash increase of $40.0 million for the quarter. The $40.0 million increase in cash represents the $55.7 million in net cash proceeds received from the Company’s follow-on public offering during January 2018 offset by $15.7 million of net cash expenditures during the first quarter 2018. The Company ended the first quarter of 2018 with 30.2 million shares outstanding.

 



 

For the first quarter of 2018, Stemline had a net loss of $18.4 million, or $0.69 per share, compared with a net loss of $14.6 million, or $0.67 per share, for the same period in 2017.

 

Research and development expense was $12.7 million for the quarter ended March 31, 2018, compared with $9.6 million for the quarter ended March 31, 2017, representing an increase of $3.1 million. The higher costs are primarily driven by an increase in regulatory and manufacturing expenses in support of our BLA filing and potential commercialization of SL-401.

 

General and administrative expense was $5.9 million for the quarter ended March 31, 2018, compared with $5.4 million for the quarter ended March 31, 2017, representing an increase of $0.5 million. The increase in expense was due to $0.9 million in higher pre-launch expenses in support of preparing for a potential commercialization of SL-401 in BPDCN, if marketing approval from the FDA is received. Additionally, the higher costs also resulted from a $0.9 million increase in non-cash stock-based compensation expense and increased headcount. Partially offsetting the higher costs was a decrease in legal expenses of $1.3 million.

 

About BPDCN

Please visit the BPDCN disease awareness booth (#4125) at ASCO 2018 and www.bpdcninfo.com.

 

About Stemline Therapeutics

 

Stemline Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel oncology therapeutics. Stemline is developing three clinical stage product candidates, SL-401, SL-801, and SL-701. 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), for which it was granted breakthrough therapy designation (BTD). The pivotal trial met its primary endpoint, and a rolling Biologics License Application (BLA) submission has been initiated. SL-401 is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and myeloma. SL-801 is a novel oral small molecule reversible inhibitor of XPO1 that is currently in a Phase 1 trial of patients with advanced solid tumors; dose escalation is ongoing. SL-701, an immunotherapeutic, has completed a Phase 2 trial in patients with second-line glioblastoma; data and next steps for the program are being evaluated.

 

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 FDA; the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, institutional review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities including the risk that the FDA or other ex-U.S. national drug authority ultimately does not agree with our data, find our data supportive of approval, or approve any of our product candidates; our plans to develop and commercialize our product candidates; market acceptance of our products; reimbursement available for our products; our available cash and investments; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to manufacture; the performance of third-party manufacturers, clinical research organizations, clinical trial sponsors and clinical trial investigators; and other risk factors identified from time to time in our reports filed with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release.

 



 

We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

 

Contact

 

Investor Relations

Stemline Therapeutics, Inc.

750 Lexington Avenue

Eleventh Floor

New York, NY 10022

Tel: 646-502-2307

Email: investorrelations@stemline.com

 



 

Table 1. Stemline Therapeutics, Inc. - Balance Sheets

 

 

 

March 31, 2018
(Unaudited)

 

December 31, 2017

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

15,230,838

 

$

4,795,098

 

Short-term investments

 

84,276,796

 

46,924,612

 

Prepaid expenses and other current assets

 

1,097,642

 

469,067

 

Total current assets

 

100,605,276

 

52,188,777

 

Property and equipment, net

 

124,886

 

136,672

 

Long-term investments

 

6,733,137

 

14,468,414

 

Other Assets

 

212,305

 

212,305

 

 

 

 

 

 

 

Total assets

 

$

107,675,604

 

$

67,006,168

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

 

$

19,488,507

 

$

19,742,087

 

Other current liabilities

 

96,827

 

96,826

 

Total current liabilities

 

19,585,334

 

19,838,913

 

Other liabilities

 

72,620

 

96,826

 

Total liabilities

 

19,657,954

 

19,935,739

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at March 31, 2018 and December 31, 2017

 

 

 

Common stock $0.0001 par value, 53,750,000 shares authorized at March 31, 2018 and December 31, 2017. 30,216,530 shares issued and outstanding at March 31, 2018 and 25,313,595 shares issued and outstanding at December 31, 2017

 

3,022

 

2,531

 

Additional paid-in capital

 

310,857,448

 

251,489,546

 

Accumulated other comprehensive loss

 

(150,377

)

(145,958

)

Accumulated deficit

 

(222,692,443

)

(204,275,690

)

Total stockholders’ equity

 

88,017,650

 

47,070,429

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

107,675,604

 

$

67,006,168

 

 



 

Table 2. Stemline Therapeutics, Inc. - Statements of Operations (Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2018

 

2017

 

Income:

 

 

 

 

 

Grant Income

 

$

 

$

299,401

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

Research and development

 

12,708,058

 

9,620,324

 

General and administrative

 

5,938,600

 

5,367,775

 

Total operating expenses

 

18,646,658

 

14,988,099

 

 

 

 

 

 

 

Loss from operations

 

(18,646,658

)

(14,688,698

)

Other expense

 

(3,897

)

 

Interest income

 

233,802

 

122,688

 

Net loss

 

$

(18,416,753

)

$

(14,566,010

)

 

 

 

 

 

 

Net loss per common share:

 

 

 

 

 

Basic and Diluted

 

$

(0.69

)

$

(0.67

)

 

 

 

 

 

 

Weighted-average shares outstanding:

 

 

 

 

 

Basic and Diluted

 

26,845,983

 

21,810,559