Full Press Release Details
GLYCOMIMETICS REPORTS SECOND QUARTER 2018 RESULTS AND HIGHLIGHTS RECENT COMPANY ACHIEVEMENTS
ROCKVILLE, MD, August 9, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results for the second quarter ended June 30, 2018 and highlighted recent company achievements. Quarter-end cash at June 30, 2018 was $229.4 million.
Our second-quarter 2018 accomplishments reflect significant progress as we finalized our plans to conduct a comprehensive Phase 3 development program for uproleselan across the spectrum of AML. With our announcement in May of an NCI CRADA, in addition to the previously announced trial in Europe sponsored by the prestigious HOVON consortium and our own sponsored registration trial, we are now planning three separate randomized, controlled trials, which we believe should provide clear efficacy and safety outcome measures in each of settings being evaluated, said Rachel King, GlycoMimetics Chief Executive Officer. The unique mechanism of action of uproleselan allows for the potential treatment of not only relapsed/refractory AML patients, but also older, newly diagnosed AML patients who are considered to be either fit or unfit for intensive chemotherapy. If successful, we believe that the combination of these trials could position us to offer a new standard treatment across the continuum of care in AML.
Key Operational Highlights for the Second Quarter of 2018:
Second Quarter 2018 Financial Results:
The company will host a conference call and webcast tomorrow, Friday, August 10, 2018, at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 3876308. To access the live audio webcast, or the subsequent archived recording, visit the Investors - Events & Presentations section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.
About Uproleselan (GMI-1271)
Uproleselan 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. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-
related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects. The FDA has granted uproleselan Breakthrough Therapy designation for the treatment of adult AML patients with relapsed/refractory (R/R) disease. GlycoMimetics plans to implement a comprehensive development program across the clinical spectrum of AML. This will include a company sponsored Phase 3 trial in R/R AML and two consortia-sponsored trials in newly diagnosed patients. One consortium trial will be sponsored by the NCI and will enroll newly diagnosed patients fit for intensive chemotherapy. The other trial will be sponsored by the HOVON group in Europe and will enroll newly diagnosed patients unfit for intensive chemotherapy.
Rivipansel, the most advanced drug candidate in the GlycoMimetics pipeline, is a glycomimetic drug candidate that acts as a pan-selectin antagonist, meaning it binds to all three members of the selectin family E-, P- and L-selectin. The first potential indication for rivipansel is VOC of SCD, one of the most severe complications of SCD which can result in acute ischemic organ injury at one or more sites. By reducing cell adhesion, activation and inflammation that are believed to contribute to reduced blood flow through the microvasculature during VOC, GlycoMimetics believes that rivipansel could be the first drug to interrupt the underlying cause of VOC, thereby potentially enabling patients to leave the hospital more quickly. Pfizer is conducting a Phase 3 clinical trial for rivipansel in SCD.
GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma (MM) or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GMI-1359 is currently in Phase 1 testing in healthy volunteers.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics has three clinical-stage programs: rivipansel, uproleselan and GMI-1359. In addition, the company is researching additional pre-clinical stage compounds based on its
specialized chemistry expertise. 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, including the expected timing of completion of clinical trials 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 filed with the U.S. Securities and Exchange Commission (SEC) on March 6, 2018, 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
Email: sannes@annesassociates.com
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Condensed Statements of Operations
(In thousands, except share and per share data)
| Three months ended June 30, | Six months ended June 30, | ||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||
| (Unaudited) | (Unaudited) | ||||||||||||
| Revenue | $ | $ | $ | $ | |||||||||
| Costs and expenses: | |||||||||||||
| Research and development expense | 9,302 | 5,722 | 18,324 | 11,601 | |||||||||
| General and administrative expense | 2,847 | 2,522 | 5,702 | 4,614 | |||||||||
| Total costs and expenses | 12,149 | 8,244 | 24,026 | 16,215 | |||||||||
| Loss from operations | (12,149) | (8,244) | (24,026) | (16,215) | |||||||||
| Other income | 870 | 102 | 1,234 | 142 | |||||||||
| Net loss and comprehensive loss | $ | (11,279) | $ | (8,142) | $ | (22,792) | $ | (16,073) | |||||
| Net loss per common share basic and diluted | $ | (0.26) | $ | (0.30) | $ | (0.58) | $ | (0.63) | |||||
| Weighted average common shares basic and diluted | 42,809,840 | 27,239,902 | 38,982,965 | 25,360,167 |
| June 30, | December 31, | ||||||
| 2018 | 2017 | ||||||
| (Unaudited) | |||||||
| Cash and cash equivalents | $ | 229,435 | $ | 123,925 | |||
| Working capital | 225,881 | 119,045 | |||||
| Total assets | 235,696 | 128,583 | |||||
| Total liabilities | 7,701 | 8,882 | |||||
| Total stockholders' equity | 227,995 | 119,701 |