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): November 9, 2017

 

Stemline Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

001-35619

 

45-0522567

(State or Other Jurisdiction

 

(Commission File Number)

 

(IRS Employer Identification No.)

of Incorporation)

 

 

 

 

 

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 November 9, 2017, Stemline Therapeutics, Inc. issued a press release to provide a corporate update and to announce its financial results for the third quarter ended September 30, 2017. 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 November 9, 2017.

 

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: November 9, 2017

Stemline Therapeutics, Inc.

 

(Registrant)

 

 

 

By

/s/ Kenneth Hoberman

 

 

Kenneth Hoberman

 

 

Chief Operating Officer

 

3


Exhibit 99.1

 

 

Stemline Therapeutics Reports Third Quarter 2017 Financial Results

 

NEW YORK, NY, November 9, 2017 (GLOBE NEWSWIRE)—Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, announced today financial results for the quarter ended September 30, 2017. The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

 

Pivotal Trial of SL-401 In Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

 

·                  On October 31, 2017, we announced that the pivotal trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) met its primary endpoint.

 

·                  We anticipate that a Biologics License Application (BLA) submission could begin in the fourth quarter of 2017 or first quarter of 2018.

 

·                  We plan to have detailed data on this trial presented at the upcoming 2017 American Society of Hematology (ASH) Annual Meeting, being held December 9-12 in Atlanta, GA.

 

Additional Clinical Trials — SL-401, SL-801, SL-701

 

·                  SL-401 is also being evaluated in ongoing Phase 1/2 trials in additional indications including certain myeloproliferative neoplasms (MPN) (chronic myelomonocytic leukemia [CMML] and myelofibrosis [MF]), acute myeloid leukemia (AML), and multiple myeloma, as a single agent or in combination with other agents. We expect to provide updates on some of these studies at ASH and on into next year.

 

·                  SL-801 Phase 1 results in patients with advanced solid tumors were the subject of a presentation at the European Society of Medical Oncology (ESMO) Annual Congress in September. Dose escalation is ongoing, and the trial is currently enrolling patients in the eighth dosing cohort.

 

·                  SL-701 has completed dosing in a Phase 2 trial of patients with second-line glioblastoma. We plan to provide an update on the trial at the upcoming Society for Neuro-Oncology (SNO) meeting in November.

 

Third Quarter 2017 Financial Results Review

 

Stemline ended the third quarter of 2017 with $79.9 million in cash, cash equivalents and investments, as compared to $93.2 million as of June 30, 2017, which reflects cash expenditures of $13.3 million for the quarter. The company ended the third quarter of 2017 with 25.3 million shares outstanding.

 

For the third quarter of 2017, Stemline had a net loss of $16.1 million, or $0.68 per share, compared with a net loss of $9.9 million, or $0.56 per share, for the same period in 2016.

 

Research and development expense was $12.4 million for the quarter ended September 30, 2017, compared with $7.2 million for the quarter ended September 30, 2016, representing an increase of $5.2 million. The higher costs are primarily driven by an increase of $2.4 million in manufacturing expenses to support our upcoming potential BLA filing for SL-401. We also incurred $2.1 million in higher regulatory costs to support our potential BLA filing for SL-401.

 

General and administrative expense was $4.2 million for the quarter ended September 30, 2017, compared with $3.2 million for the quarter ended September 30, 2016, representing an increase of $1.0 million. The increase in expense was primarily attributable to $0.6 million in higher legal expenses. Additionally, the higher costs were due to $0.2 million of pre-launch expenses in support of a potential commercialization of SL-401 in BPDCN, if marketing approval from the FDA is received.

 



 

About Stemline Therapeutics

 

Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers. 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), a cell surface receptor expressed on a variety of malignancies including blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive, lethal malignancy of unmet medical need, with no approved therapies. SL-401 was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with BPDCN. A pivotal Phase 2 trial with SL-401 in BPDCN has completed enrollment. An additional cohort is currently enrolling BPDCN patients to ensure continued access to SL-401. Additional Phase 1/2 trials with SL-401, including as a single agent or in combination with other agents, are ongoing in patients with other malignancies including myeloproliferative neoplasms (MPN) (focused on chronic myelomonocytic leukemia [CMML] and myelofibrosis [MF]), acute myeloid leukemia (AML), and multiple myeloma. A Phase 1 trial of SL-801, a novel oral small molecule reversible XPO1 inhibitor, is enrolling patients with advanced solid tumors. Results presented at the European Society of Medical Oncology (ESMO) Annual Congress in September 2017 included dose escalation data of SL-801 through 6 dosing cohorts without dose limiting toxicity. The ideal therapeutic dose of SL-801 has not yet been determined and dose escalation/schedule optimization continues. A Phase 2 trial of SL-701, an immunotherapeutic, has completed dosing of patients with second-line glioblastoma and patients are being followed for outcomes including survival.

 

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 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 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 Securities and Exchange Commission. 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

 

 

 

September 30, 2017
(Unaudited)

 

December 31, 2016

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

10,265,356

 

$

10,316,064

 

Short-term investments

 

55,259,923

 

36,562,900

 

Prepaid expenses and other current assets

 

598,356

 

290,747

 

Total current assets

 

66,123,635

 

47,169,711

 

Property and equipment, net

 

145,968

 

22,531

 

Long-term investments

 

14,348,432

 

20,714,551

 

Other Assets

 

212,305

 

212,305

 

Total assets

 

$

80,830,340

 

$

68,119,098

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses.

 

$

14,368,329

 

$

9,284,514

 

Current portion of deferred grant revenue

 

 

898,199

 

Other current liabilities

 

96,827

 

71,100

 

Total current liabilities

 

14,465,156

 

10,253,813

 

Other liabilities

 

121,033

 

142,200

 

Total liabilities

 

14,586,189

 

10,396,013

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at September 30, 2017 and December 31, 2016

 

 

 

Common stock $0.0001 par value, 53,750,000 shares authorized at September 30, 2017 and 33,750,000 shares authorized at December 31, 2016. 25,271,907 shares issued and outstanding at September 30, 2017 and 19,219,223 shares issued and outstanding at December 31, 2016

 

2,527

 

1,922

 

Additional paid-in capital

 

248,855,696

 

193,563,572

 

Accumulated other comprehensive loss

 

(87,683

)

(99,802

)

Accumulated deficit

 

(182,526,389

)

(135,742,607

)

Total stockholders’ equity

 

66,244,151

 

57,723,085

 

Total liabilities and stockholders’ equity

 

$

80,830,340

 

$

68,119,098

 

 



 

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

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

 

2017

 

2016

 

2017

 

2016

 

Revenues:

 

 

 

 

 

 

 

 

 

Grant revenue

 

$

299,397

 

$

299,401

 

$

898,199

 

$

741,953

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

12,417,652

 

7,176,960

 

33,517,006

 

20,585,659

 

General and administrative

 

4,152,449

 

3,187,869

 

14,000,854

 

8,914,630

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

16,570,101

 

10,364,829

 

47,517,860

 

29,500,289

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(16,270,704

)

(10,065,428

)

(46,619,661

)

(28,758,336

)

 

 

 

 

 

 

 

 

 

 

Other income

 

381

 

1,378

 

381

 

11,736

 

Other expense

 

(3,566

)

 

(3,566

)

 

Interest income

 

217,742

 

132,006

 

543,753

 

417,113

 

 

 

 

 

 

 

 

 

 

 

Net loss before income taxes

 

(16,056,147

)

(9,932,044

)

(46,079,093

)

(28,329,487

)

 

 

 

 

 

 

 

 

 

 

Income tax benefit

 

 

8,822

 

 

35,578

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(16,056,147

)

$

(9,923,222

)

$

(46,079,093

)

$

(28,293,909

)

 

 

 

 

 

 

 

 

 

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

$

(0.68

)

$

(0.56

)

$

(2.01

)

$

(1.59

)

 

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

23,464,505

 

17,831,022

 

22,901,883

 

17,777,675