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GlycoMimetics(GLYC) - 2022 Q3 - Quarterly Report
2022-11-09 13:30
Table of Contents For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36177 GlycoMimetics, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) Delaware 06-1686563 (Stat ...
GlycoMimetics(GLYC) - 2022 Q2 - Earnings Call Transcript
2022-08-03 20:08
Financial Data and Key Metrics Changes - As of June 30, 2022, GlycoMimetics had cash equivalents of $60.2 million, down from $90.3 million as of December 31, 2021, with expectations that current cash resources will fund operations into the third quarter of 2023 [34] - Research and development expenses decreased to $8 million for the quarter ended June 30, 2022, compared to $10.2 million for the same period in 2021, primarily due to lower clinical trial costs related to the ongoing Phase III trial of uproleselan [35] - General and administrative expenses increased to $5.5 million for the quarter ended June 30, 2022, compared to $4.2 million for the second quarter of 2021, mainly due to commercialization startup expenses for uproleselan [36] Business Line Data and Key Metrics Changes - The Phase III trial of uproleselan is currently evaluating salvage chemotherapy with or without the drug, with a primary endpoint of overall survival [10] - The Phase III population is broadly similar to the Phase I/II study regarding age, severity of AML, and prior stem cell transplantation rates, with a median age of 58 years [11] - The Phase II portion of the NCI trial has completed enrollment of 267 patients, with an interim analysis planned [13] Market Data and Key Metrics Changes - AML is one of the most common types of leukemia in adults, with a global median incidence rate of almost 2.3 cases per 100,000, and over 20,000 adults diagnosed annually in the U.S. [23] - Long-term patient outcomes in AML are poor, with approximately 70% of newly diagnosed patients relapsing within three years and a five-year overall survival rate of 29% [24] - Current standard-of-care therapies for AML are limited in achieving deep, durable remissions, with only 20% to 30% of relapsed refractory patients achieving complete remission [26] Company Strategy and Development Direction - The company is focused on advancing the development of uproleselan and preparing for its potential commercialization, with a strong emphasis on regulatory and commercial readiness [8] - GlycoMimetics aims to establish uproleselan as a first-in-class E-selectin antagonist to disrupt the standard of care in both relapsed refractory and newly diagnosed AML [21] - The company is also exploring partnerships for GMI-1687, a sickle cell disease program, while prioritizing resources on uproleselan development [17][56] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the potential of uproleselan to transform outcomes in AML patients, with a projected event trigger for overall survival expected in mid-2023 [12] - The company is committed to closely monitoring the Phase III trial and will provide updates as necessary [41] - Management emphasizes the importance of physician awareness and enthusiasm for uproleselan, indicating a significant market opportunity [30] Other Important Information - The company has received FDA fast-track and breakthrough therapy designation for uproleselan in relapsed refractory AML, facilitating rapid regulatory submissions [12] - The company is preparing for potential market entry of uproleselan and is focused on ensuring resources are allocated effectively for commercialization [19] Q&A Session Summary Question: How are the OS events tracking versus projections for the uproleselan Phase III trial? - Management confirmed that the overall survival events are still tracking in line with previous projections, expected to mature in mid-2023 [41] Question: When will initial results from the combination studies with venetoclax be available? - Management indicated that initial data might be available as early as the upcoming ASH conference, but the timeline depends on the principal investigators [43] Question: Are there differences in patient baseline characteristics between the Phase III and Phase II trials? - Management acknowledged that while the characteristics are broadly similar, there are slight differences in terms of prior remission duration and risk categories [46] Question: How often will updates be received from the NCI study? - Management stated that updates will be provided once the NCI completes their analysis, with the expectation that results will be communicated in a timely manner [50] Question: What is the status of business development activities and cash runway? - Management emphasized that business development remains a focus, particularly for GMI-1687, and that cash resources are being preserved to prioritize uproleselan [56][58]
GlycoMimetics (GLYC) Investor Presentation - Slideshow
2021-11-23 13:10
NASDAQ: GLYC Nov 2021 Glycobiology-based therapeutics Transforming lives Harout Semerjian President and CEO © 2021 GlycoMimetics, Inc. All rights reserved. Forward-Looking Statements 2 • To the extent that statements contained in this presentation are not descriptions of historical facts regarding GlycoMimetics, Inc. ("GlycoMimetics," "we," "us," or "our"), they are forward-looking statements reflecting management's current beliefs and expectations. Forward-looking statements are subject to known and unknow ...
GlycoMimetics(GLYC) - 2021 Q3 - Earnings Call Transcript
2021-11-02 18:50
GlycoMimetics, Inc. (NASDAQ:GLYC) Q3 2021 Earnings Conference Call November 2, 2021 8:30 AM ET Company Participants Shari Annes - IR Harout Semerjian - CEO, President & Director Eric Feldman - SVP & Chief Medical Officer Brian Hahn - SVP & CFO Conference Call Participants Edward White - H.C. Wainwright & Co. Zegbeh Jallah - ROTH Capital Partners Jiale Song - Jefferies Operator Good morning, and thank you all for joining the GlycoMimetics call. [Operator Instructions]. I would now like to turn the call over ...
GlycoMimetics(GLYC) - 2021 Q3 - Quarterly Report
2021-11-02 12:30
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36177 GlycoMimetics, Inc. (Exact name of registrant as specified in its charter) Delaware 06-1686563 (State or Other Jurisdiction of Incorporation or Organization) 9708 Medical Center Drive Rockville, Maryland 20850 (Address of principal executive offices) ...
GlycoMimetics (GLYC) Investor Presentation - Slideshow
2021-09-26 16:23
Glycobiology-based therapeutics Transforming lives Harout Semerjian President and CEO NASDAQ: GLYC September 2021 © 2021 GlycoMimetics, Inc. All rights reserved. Forward-Looking Statements • To the extent that statements contained in this presentation are not descriptions of historical facts regarding GlycoMimetics, Inc. ("GlycoMimetics," "we," "us," or "our"), they are forward-looking statements reflecting management's current beliefs and expectations. Forward-looking statements are subject to known and un ...
GlycoMimetics(GLYC) - 2021 Q2 - Earnings Call Transcript
2021-08-08 09:56
GlycoMimetics, Inc. (NASDAQ:GLYC) Q2 2021 Earnings Conference Call August 5, 2021 8:30 AM ET Company Participants Shari Annes - Investor Relations Rachel King - Chief Executive Officer Eric Feldman - Senior Vice President and Chief Medical Officer Brian Hahn - Senior Vice President and Chief Financial Officer Harout Semerjian - President and Chief Executive Officer Conference Call Participants Edward White - H.C. Wainwright Roger Song - Jefferies Operator Good morning, and thank you all for joining GlycoMim ...
GlycoMimetics(GLYC) - 2021 Q2 - Quarterly Report
2021-08-05 12:16
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36177 GlycoMimetics, Inc. (Exact name of registrant as specified in its charter) Delaware 06-1686563 (State or ...
GlycoMimetics(GLYC) - 2021 Q1 - Quarterly Report
2021-05-03 12:30
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36177 GlycoMimetics, Inc. (Exact name of registrant as specified in its charter) Delaware 06-1686563 (State or ...
GlycoMimetics(GLYC) - 2020 Q4 - Annual Report
2021-03-02 13:31
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 Commission file number 001-36177 GlycoMimetics, Inc. (Exact name of Registrant as specified in its charter) Delaware 06-1686563 (State or other jurisdiction of incorporation or organization) 9708 Medical Center Drive Rockville, Maryland 20850 (Address of principal executive offices) ...