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): November 4, 2016
GlycoMimetics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-36177 |
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06-1686563 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer |
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 November 4, 2016, GlycoMimetics, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended September 30, 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
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Exhibit |
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Number |
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Exhibit Description |
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99.1 |
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Press Release, dated November 4, 2016, “GlycoMimetics Reports Third Quarter 2016 Results and Progress in Clinical Development.” |
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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.
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GLYCOMIMETICS, INC. |
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By: |
/s/ Brian M. Hahn |
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Date: November 4, 2016 |
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Brian M. Hahn |
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EXHIBIT INDEX
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Number |
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Exhibit Description |
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99.1 |
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Press Release, dated November 4, 2016, “GlycoMimetics Reports Third Quarter 2016 Results and Progress in Clinical Development.” |
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Exhibit 99.1
GLYCOMIMETICS REPORTS THIRD QUARTER 2016 RESULTS AND PROGRESS IN CLINICAL DEVELOPMENT
ROCKVILLE, MD, November 4, 2016 – GlycoMimetics, Inc. (NASDAQ: GLYC) today reported progress on its clinical development programs and its financial results for the quarter ended September 30, 2016.
“For GlycoMimetics, the third quarter was highlighted by continued achievements in our clinical development programs, particularly with regard to GMI-1271, our clinical-stage E-selectin antagonist. We announced initiation of a Phase 1 clinical trial of GMI-1271 in multiple myeloma, expanding potential uses of the drug candidate. We continue to enroll the Phase 2 portion of the GMI-1271 AML trial in both newly diagnosed and relapsed/refractory patients. We also announced the initiation of a Phase 1 clinical trial of our next drug candidate, GMI-1359, in healthy volunteers. After the close of the quarter, we announced the acceptance of multiple abstracts for six posters and one oral presentation at ASH in December 2016. With our new trial initiations and continued enrollment in our ongoing trials, we expect to be in a position to provide additional news on the clinical development of GMI-1271 and GMI-1359 in late 2016 and throughout 2017,” said Rachel King, GlycoMimetics’ Chief Executive Officer.
Key Operational Highlights:
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· |
GlycoMimetics dosed the first patient in a Phase 1 clinical trial of GMI-1271 for multiple myeloma (MM) in September 2016. The multi-center, open-label dose escalation trial, which has begun in Ireland, is designed to measure the efficacy, safety and pharmacokinetics of GMI-1271 in combination with bortezomib-based chemotherapy among patients who have been diagnosed with MM and have not responded well to standard chemotherapy. |
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· |
GlycoMimetics initiated dosing in a Phase 1 clinical trial of its next drug candidate, GMI-1359, in healthy volunteers. GMI-1359 is a small molecule drug candidate that simultaneously inhibits both E-selectin and CXCR4. In this first-in-humans trial, volunteer participants will receive a single injection of GMI-1359, after which they will be evaluated for safety, tolerability, pharmacokinetics |
and pharmacodynamics over 16 days. The randomized, double-blind escalating dose study is being conducted at a single site in the United States. |
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We continue to recruit and dose patients in the Phase 2 portion of our clinical study evaluating GMI-1271 in AML in both newly diagnosed and relapsed/refractory patients at 8 active sites in the United States, Ireland and Australia. Having recently been granted fast track status by the FDA for GMI-1271 in this indication, GlycoMimetics plans to continue to engage with the FDA to discuss clinical and manufacturing planning as the program progresses. |
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GlycoMimetics also recently announced that six posters and one oral presentation on data from three of the company’s clinical programs will be presented at the American Society of Hematology’s Annual Meeting in December 2016. |
Third Quarter 2016 Financial Results:
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Cash position: As of September 30, 2016, the Company had cash and cash equivalents of $45.3 million as compared to $46.8 million as of December 31, 2015. |
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Revenue: Revenue for the three-month periods ended September 30, 2016 and 2015 was not material. There were no milestone or royalty payments due from Pfizer during the three months ended September 30, 2016 or 2015. |
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R&D Expenses: The Company’s research and development expenses increased to $5.9 million for the quarter ended September 30, 2016 as compared to $5.0 million for the third quarter of 2015. The increase was due to higher costs associated with the clinical trials for GMI-1271 in AML and MM and for GMI-1359 in healthy volunteers, partially offset by a decrease in expenses related to manufacturing and process development for GMI-1271. |
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G&A Expenses: The Company’s general and administrative expenses decreased to $2.0 million for the quarter ended September 30, 2016 as compared to $2.1 million for the third quarter of 2015. The decrease was related to slightly lower legal expenses, patent fees and commercial research fees. |
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Shares Outstanding: Shares outstanding as of September 30, 2016 were 23,063,430. |
About GMI-1271
GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug's potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies using animal models of AML, the results of which were presented at meetings of the American Society of Hematology (ASH), GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. Since E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow, we believe that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that affect the bone marrow such as AML and MM, as compared to targeting CXCR4 alone. In December 2015 at the annual meeting of the American Society of Hematology, we presented preclinical data suggesting that GMI-1359 may enhance the ability of chemotherapy to target and improve survival rates in patients with a high-risk form of mutated AML.
About Rivipansel
GlycoMimetics’ most advanced 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.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company focused on cancer and sickle cell disease. Using our expertise in carbohydrate chemistry and knowledge of carbohydrate biology, we are developing a pipeline of proprietary glycomimetics that inhibit disease-related functions of carbohydrates, such as the roles they play in inflammation, cancer and infection. We believe this represents an innovative approach to drug discovery to treat a wide range of diseases. 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)
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Three months ended September 30, |
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Nine months ended September 30, |
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2016 |
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2015 |
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2016 |
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2015 |
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(Unaudited) |
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(Unaudited) |
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Revenue |
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$ |
18 |
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$ |
— |
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$ |
18 |
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$ |
20,035 |
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Costs and expenses: |
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Research and development expense |
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5,921 |
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5,038 |
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17,221 |
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18,089 |
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General and administrative expense |
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1,984 |
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2,133 |
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6,352 |
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5,844 |
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Total costs and expenses |
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7,905 |
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7,171 |
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23,573 |
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23,933 |
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Loss from operations |
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(7,887) |
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(7,171) |
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(23,555) |
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(3,898) |
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Other income |
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32 |
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3 |
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74 |
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10 |
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Net loss and comprehensive loss |
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$ |
(7,855) |
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$ |
(7,168) |
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$ |
(23,481) |
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$ |
(3,888) |
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Net loss per share – basic and diluted |
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$ |
(0.34) |
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$ |
(0.38) |
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$ |
(1.14) |
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$ |
(0.20) |
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Weighted average shares – basic and diluted |
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23,049,347 |
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19,025,623 |
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20,638,129 |
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18,999,705 |
GlycoMimetics, Inc.
Balance Sheet Data
(In thousands)
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September 30, |
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December 31, |
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2016 |
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2015 |
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(unaudited) |
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Cash and cash equivalents |
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$ |
45,283 |
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$ |
46,803 |
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Working capital |
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41,104 |
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39,497 |
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Total assets |
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48,011 |
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48,462 |
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Total liabilities |
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6,259 |
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7,991 |
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Total stockholders' equity |
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41,751 |
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40,472 |
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