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 9, 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 August 9, 2018, 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, 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 August 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: August 9, 2018

Stemline Therapeutics, Inc.

 

(Registrant)

 

 

 

 

 

 

By

/s/ Kenneth Hoberman

 

 

Kenneth Hoberman

 

 

Chief Operating Officer

 

3


Exhibit 99.1

 

 

Stemline Therapeutics Reports Second Quarter 2018 Financial Results

 

NEW YORK, August 9, 2018 (GLOBE NEWSWIRE) — Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, announced today its financial results for the quarter ended June 30, 2018. The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

 

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 the European Hematology Association (EHA) in Stockholm, Sweden.

 

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

 

·                  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.

 

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.

 

Ivan Bergstein, MD, CEO of Stemline, commented, “We have completed our rolling BLA submission and are quickly approaching the very important milestone of a potential BLA acceptance for filing by the FDA. We continue to advance closer to our ultimate goal of potentially making ELZONRIS widely available to patients with BPDCN. In parallel, ELZONRIS continues to generate very promising clinical data in additional indications including CMML and MF, two settings of unmet medical need for which we are actively evaluating registration pathways. Additionally, we continue to expand our commercial infrastructure including the build out of our sales and marketing teams ahead of our potential approval.”

 

Second Quarter 2018 Financial Results Review

 

Stemline ended the second quarter of 2018 with $97.1 million in cash, cash equivalents and investments, with a cash burn of $17.6 million in the second quarter. The Company ended the second quarter of 2018 with 30.9 million shares outstanding. For the second quarter of 2018, Stemline had a net loss of $18.9 million, or $0.66 per share, compared with a net loss of $15.5 million, or $0.66 per share, for the same period in 2017.

 

Research and development expense was $11.2 million for the quarter ended June 30, 2018, compared with $11.5 million for the quarter ended June 30, 2017, representing a decrease of $0.3 million.

 

General and administrative expense was $8.6 million for the quarter ended June 30, 2018, compared with $4.5 million for the quarter ended June 30, 2017, representing an increase of $4.1 million. The increase in expense was primarily attributed to a $3.0 million increase in pre-launch expenses in support of our potential commercialization of ELZONRIS in BPDCN, if marketing approval from the FDA is received. Additionally, the higher expense was also due to an increase of non-cash stock-based compensation expense and increased headcount.

 

About BPDCN


Please visit the BPDCN disease awareness website: 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, ELZONRISTM (tagraxofusp; SL-401), SL-801, and SL-701. ELZONRIS is a targeted therapy directed to the interleukin-3 receptor (CD123) present on a range of malignancies. ELZONRIS 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 completed. ELZONRIS is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and other indications. 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

 

 

 

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

 

 

 

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