glyc_Current_Folio_8K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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 4, 2016

 


 

GlycoMimetics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

Delaware

 

001-36177

 

06-1686563

(State or other jurisdiction of incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

9708 Medical Center Drive

Rockville, MD 20850

(Address of principal executive offices, including zip code)

 

(240) 243-1201

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

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:

[  ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 


 

 

Item 2.02  Results of Operations and Financial Condition.

 

On May 4, 2016, GlycoMimetics, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended March 31, 2016. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

 

In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits. 

 

(d) Exhibits

 

 

 

Exhibit

 

 

Number

 

Exhibit Description

99.1

 

Press Release, dated May 4, 2016, “GlycoMimetics Reports First Quarter 2016 Results.”

 

 

2


 

 

 

SIGNATURES

 

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.

 

  

 

 

 

 

GLYCOMIMETICS, INC.

 

 

 

 

By:  

/s/ Brian M. Hahn

Date:  May 4, 2016

 

Brian M. Hahn
Chief Financial Officer

 

3


 

 

EXHIBIT INDEX

 

 

 

 

Exhibit

 

 

Number

 

Exhibit Description

99.1

 

Press Release, dated May 4, 2016, “GlycoMimetics Reports First Quarter 2016 Results.”

 

4


glyc_Ex99_1

Exhibit 99.1

Picture 1

 

 

GLYCOMIMETICS REPORTS FIRST QUARTER 2016 RESULTS

 

ROCKVILLE, MD, May 4, 2016 –  GlycoMimetics, Inc. (NASDAQ: GLYC) today reported financial results for the first quarter ended March 31, 2016. 

“In February of 2016, we announced the topline readout of data from the first two cohorts in our ongoing Phase 1/2 clinical trial evaluating our drug candidate GMI-1271 in relapsed/refractory acute myeloid leukemia (AML) patients. Of the first 13 evaluable patients dosed with GMI-1271 in combination with chemotherapy, investigators observed clinical responses in eight patients, for an overall response rate of 62 percent. This group of 13 patients also tolerated GMI-1271 well. This is an important finding, and it is our plan to present the data in greater detail at a major medical meeting,” said Rachel King, GlycoMimetics’ Chief Executive Officer. “In addition, we plan soon to initiate clinical development of GMI-1359, our third product candidate, also with a novel mechanism of action targeting E-selectin and CXCR4, an important target believed to play a key role in cancer cell migration and infiltration. Here our initial indications will likely also be hematological cancers, but in the future we may expand into solid tumors as well. We anticipate filing an investigational new drug application (IND) with the U.S. Food & Drug Administration for GMI-1359 in the third quarter of 2016.”

As of March 31, 2016, GlycoMimetics had cash and cash equivalents of $38.8 million. GlycoMimetics reported no revenue for the quarter ended March 31, 2016 or the quarter ended March 31, 2015. The company’s research and development expenses increased to $5.5 million for the quarter ended March 31, 2016 as compared to $5.2 million for the first quarter of 2015. During the three months ended March 31, 2016, our research and development expense increased by approximately $300,000 compared to the same period in 2015, an increase of 6 percent that was primarily attributable to an increase in GMI-1271 clinical trial costs, offset in part by a decrease in expenses related to manufacturing and process development for GMI-1271. In addition, the preclinical development of GMI-1359 has resulted in increased expenses in manufacturing and for toxicology studies required to support a potential IND filing.  The company’s general and administrative expenses increased slightly to $2.1 million for the quarter ended March 31, 2016 as compared to $1.9 million for the first quarter of 2015.  These increases were primarily due to increased headcount and associated salaries and stock-based compensation expense.

About GlycoMimetics, Inc.

GlycoMimetics is a clinical-stage biotechnology company focused on sickle cell disease and cancer.  GlycoMimetics’ first drug candidate, rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by its strategic collaborator, Pfizer. GlycoMimetics’ wholly-owned drug candidate, GMI-1271, an


 

E-selectin antagonist, is being evaluated in an ongoing Phase 1/ 2 clinical trial as a potential treatment for AML and other blood disorders. GlycoMimetics expects to file an IND with the FDA for a third drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist, in the third quarter of 2016. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.  

 

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements regarding the clinical development of the company’s drug candidates and the presentation of clinical data. Actual results may differ materially from those in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the company’s annual report on Form 10-K that was filed with the U.S. Securities and Exchange Commission (SEC) on February 29, 2016, and other filings GlycoMimetics makes with the SEC from time to time. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.

 

# # #

Source: GlycoMimetics

 

Investor Contact:

Shari Annes

Phone: 650-888-0902

Email: sannes@annesassociates.com

 

Media Contact:

Jamie Lacey-Moreira

Phone: 410-299-3310

Email: jamielacey@presscommpr.com


 

GlycoMimetics, Inc.

Condensed Statements of Operations

(In thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended March 31,

 

 

 

    

2016

    

2015

    

 

 

 

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

 —

 

$

 —

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

Research and development expense

 

 

5,519

 

 

5,208

 

 

General and administrative expense

 

 

2,056

 

 

1,905

 

 

Total costs and expenses

 

 

7,575

 

 

7,113

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(7,575)

 

 

(7,113)

 

 

 

 

 

 

 

 

 

 

 

Other income

 

 

20

 

 

4

 

 

 

 

 

 

 

 

 

 

 

Net loss and comprehensive loss

 

$

(7,555)

 

$

(7,109)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share – basic and diluted

 

$

(0.40)

 

$

(0.37)

 

 

Weighted average shares – basic and diluted

 

 

19,071,838

 

 

18,961,531

 

 

 

 

 

 


 

GlycoMimetics, Inc.

Balance Sheet Data

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

March 31,

 

December 31,

 

 

 

2016

 

2015

 

 

    

(unaudited)

    

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

38,830

 

$

46,803

 

 

 

 

 

 

 

 

 

Working capital

 

 

33,830

 

 

39,497

 

 

 

 

 

 

 

 

 

Total assets

 

 

40,701

 

 

48,462

 

 

 

 

 

 

 

 

 

Total liabilities

 

 

5,933

 

 

7,991

 

 

 

 

 

 

 

 

 

Total stockholders' equity

 

 

34,768

 

 

40,472