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): August 8, 2017

 

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 August 8, 2017, Stemline Therapeutics, Inc. issued a press release to provide a corporate update and to announce its financial results for the second quarter ended June 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 August 8, 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: August 8, 2017

Stemline Therapeutics, Inc.

 

(Registrant)

 

 

 

 

 

By

/s/ Kenneth Hoberman

 

 

Kenneth Hoberman

 

 

Chief Operating Officer

 

3



 

INDEX TO EXHIBITS

 

Exhibit
Number

 

Description

 

 

 

99.1

 

Press release issued by Stemline Therapeutics, Inc., dated August 8, 2017.

 

4


Exhibit 99.1

 

 

Stemline Therapeutics Reports Second Quarter 2017 Financial Results

 

NEW YORK, NY, August 8, 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 June 30, 2017. The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

 

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

 

·                  The SL-401 pivotal Phase 2 trial enrolled 45 BPDCN patients in Stages 1, 2 and 3. Stage 3 was prospectively designed to support potential registration.

 

·                  During the quarter, we presented updated data from Stages 1 and 2 of the Phase 2 trial at the 22nd Congress of the European Hematology Association (EHA) in Madrid, Spain.

 

·                  Analysis of Phase 2 data, inclusive of Stage 3, is ongoing and we remain on track to announce top-line results in 2H17. We are also targeting a medical conference to present more detailed results later this year.

 

·                  To ensure ongoing patient access to SL-401, we are enrolling both first-line and relapsed/refractory BPDCN patients in an additional cohort.

 

·                  Depending on the data from the trial, we plan to use the results generated, along with other relevant data, to support the filing of a Biologics License Application (BLA) for approval in BPDCN. We continue to anticipate a possible BLA filing could begin in 4Q17 or 1Q18.

 

Additional Clinical Trials

 

·                  Clinical trials evaluating SL-401 are ongoing in additional indications including certain myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML), and multiple myeloma, as a single agent or in combination with other agents. We expect to provide updates on these studies later this year and into next year.

 

·                  SL-801, a novel XPO1 inhibitor, is being evaluated in a Phase 1 trial of patients with advanced solid tumors. SL-701 has completed dosing in a Phase 2 trial of patients with second-line glioblastoma. We are targeting medical conferences for updates on both of these studies later this year.

 

Second Quarter 2017 Financial Results Review

 

Stemline ended the second quarter of 2017 with $93.2 million in cash, cash equivalents and investments, as compared to $105.8 million as of March 31, 2017, which reflects a use of cash of $12.6 million for the quarter. The company ended the second quarter of 2017 with 25.2 million shares outstanding.

 

For the second quarter of 2017, Stemline had a net loss of $15.5 million, or $0.66 per share, compared with a net loss of $9.3 million, or $0.52 per share, for the same period in 2016.

 

Research and development expenses were $11.5 million for the second quarter of 2017, which reflects an increase of $4.6 million, or 67%, compared with $6.9 million for the second quarter of 2016. The higher costs are primarily driven by an increase of $2.1 million in manufacturing expenses to support our potential BLA filing for SL-401. We also incurred $1.2 million in higher costs for regulatory support of our potential BLA filing for SL-401. Additionally, we incurred higher compensation expense as a result of increased headcount.

 



 

General and administrative expenses were $4.5 million for the second quarter of 2017, which reflects an increase of $1.6 million, or 57%, compared with $2.9 million for the second quarter of 2016. The increase in expense was primarily attributable to $0.7 million in pre-launch expenses in support of a potential commercialization of SL-401 in BPDCN, if marketing approval from the FDA is granted. The increase in costs was also driven by $0.4 million in higher legal expense as a result of the class action lawsuit, as well as a $0.3 million increase in non-cash stock-based compensation expense.

 

About Stemline Therapeutics

 

Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers. SL-401 is a targeted therapy directed to the interleukin-3 receptor (CD123), a cell surface receptor overexpressed on BPDCN and a variety of other hematologic cancers. SL-401 was granted Breakthrough Therapy Designation (BTD) for the treatment of patients with BPDCN. A pivotal Phase 2 trial with SL-401 in BPDCN has completed enrollment in Stages 1, 2 and 3 of the trial; to ensure ongoing patient access to SL-401, an additional cohort, Stage 4, is enrolling. Additional Phase 1/2 trials are assessing SL-401 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, as a single agent or in combination with other agents. SL-801, a novel oral small molecule reversible inhibitor of XPO1, is enrolling patients with advanced solid tumors in a Phase 1 trial. SL-701, an immunotherapeutic, has completed dosing of patients with second-line glioblastoma in a Phase 2 trial 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 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

 

 

 

June 30, 2017
(Unaudited)

 

December 31, 2016

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

8,549,890

 

$

10,316,064

 

Short-term investments

 

55,536,100

 

36,562,900

 

Prepaid expenses and other current assets

 

471,880

 

290,747

 

Total current assets

 

64,557,870

 

47,169,711

 

Furniture and fixtures, net

 

45,773

 

22,531

 

Long-term investments

 

29,157,603

 

20,714,551

 

Other Assets

 

212,305

 

212,305

 

Total assets

 

$

93,973,551

 

$

68,119,098

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses.

 

$

13,523,018

 

$

9,284,514

 

Current portion of deferred grant revenue

 

299,397

 

898,199

 

Other current liabilities

 

71,100

 

71,100

 

Total current liabilities

 

13,893,515

 

10,253,813

 

Other liabilities

 

106,650

 

142,200

 

Total liabilities

 

14,000,165

 

10,396,013

 

Stockholders’ equity:

 

 

 

 

 

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

 

 

 

Common stock $0.0001 par value, 53,750,000 shares authorized at June 30, 2017 and 33,750,000 shares authorized at December 31, 2016. 25,180,024 shares issued and outstanding at June 30, 2017 and 19,219,223 shares issued and outstanding at December 31, 2016

 

2,518

 

1,922

 

Additional paid-in capital

 

246,562,007

 

193,563,572

 

Accumulated other comprehensive loss

 

(120,897

)

(99,802

)

Accumulated deficit

 

(166,470,242

)

(135,742,607

)

Total stockholders’ equity

 

79,973,386

 

57,723,085

 

Total liabilities and stockholders’ equity

 

$

93,973,551

 

$

68,119,098

 

 



 

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

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2017

 

2016

 

2017

 

2016

 

Revenues:

 

 

 

 

 

 

 

 

 

Grant revenue

 

$

299,401

 

$

236,901

 

$

598,802

 

$

442,552

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

11,479,030

 

6,875,970

 

21,099,354

 

13,408,700

 

General and administrative

 

4,480,630

 

2,860,639

 

9,848,406

 

5,726,761

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

15,959,660

 

9,736,609

 

30,947,760

 

19,135,461

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(15,660,259

)

(9,499,708

)

(30,348,958

)

(18,692,909

)

 

 

 

 

 

 

 

 

 

 

Other income

 

 

10,359

 

 

10,359

 

Interest income

 

203,323

 

140,450

 

326,012

 

285,107

 

 

 

 

 

 

 

 

 

 

 

Net loss before income taxes

 

(15,456,936

)

(9,348,899

)

(30,022,946

)

(18,397,443

)

 

 

 

 

 

 

 

 

 

 

Income tax benefit

 

 

26,756

 

 

26,756

 

Net loss

 

$

(15,456,936

)

$

(9,322,143

)

$

(30,022,946

)

$

(18,370,687

)

 

 

 

 

 

 

 

 

 

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

$

(0.66

)

$

(0.52

)

$

(1.33

)

$

(1.03

)

 

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

23,412,409

 

17,785,406

 

22,615,909

 

17,750,709