GlycoMimetics(GLYC)

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GlycoMimetics(GLYC) - 2024 Q1 - Quarterly Report
2024-05-09 20:31
Financial Performance - The company reported an accumulated deficit of $467.2 million as of March 31, 2024, and expects to continue incurring operating losses over the next several years [96]. - The company has no revenue from drug sales and does not expect to generate revenue in the near future, relying on milestone payments from collaboration agreements [105]. - Net loss for Q1 2024 was $10,737,000, a decrease of $378,000 (4%) compared to a net loss of $10,359,000 in Q1 2023 [114]. - Interest income decreased by $204,000 (35%) to $378,000 in Q1 2024 due to lower cash and cash equivalent balances [118]. - As of March 31, 2024, the company had $31.3 million in cash and cash equivalents, with no committed source of additional funding [130]. - The company expects existing cash and cash equivalents to fund operating expenses through Q4 2024, but plans to reduce expenses to preserve capital [131]. - Net cash used in operating activities for Q1 2024 was $10,509,000, an improvement from $11,607,000 in Q1 2023 [132]. - The company sold 9,822,930 shares under the 2022 Sales Agreement in 2023, raising $28.7 million in net proceeds [120]. Drug Development - The lead drug candidate, uproleselan, showed a median overall survival of 13 months in patients treated with it, compared to 12.3 months in the placebo group during a Phase 3 trial [87]. - The company completed enrollment of 388 patients in a Phase 3 pivotal clinical trial for uproleselan in 2021, based on FDA guidance [86]. - A Cooperative Research and Development Agreement with the National Cancer Institute is in place for a Phase 2/3 trial testing uproleselan with standard chemotherapy, with 267 patients enrolled in the Phase 2 portion [88]. - The Phase 3 bridging study for uproleselan in Greater China has enrolled 140 patients, with overall survival as the primary endpoint [101]. - GMI-1687, an innovative E-selectin antagonist, completed enrollment of 40 subjects in a Phase 1a trial in December 2023 [92]. - The company is uncertain about the timing and costs associated with the development of its drug candidates, including uproleselan [125]. Capital Management - The company has raised capital primarily through private placements and collaboration agreements, with no approved drugs currently available for sale [95]. - The company plans to reduce operating expenses in the upcoming months to preserve capital, although this may not significantly extend the cash runway [97]. - A purchase commitment of $3,768,000 was entered into for raw materials to support the next commercial manufacturing campaign [123]. - The company received an upfront cash payment of $9.0 million from Apollomics for the development and commercialization of uproleselan and GMI-1687 in Greater China [100]. Expenses - Research and development expenses for Q1 2024 increased by $606,000 (11%) to $6,025,000 compared to Q1 2023 [114]. - General and administrative expenses decreased by $432,000 (8%) to $5,090,000 in Q1 2024, primarily due to lower personnel-related expenses [117].
GlycoMimetics(GLYC) - 2024 Q1 - Quarterly Results
2024-05-06 20:01
Exhibit 99.2 Forward-Looking Statements GlycoMimetics GlycoMimetics Transforming Lives Glycobiology-based Therapeutics May 2024 | NASDAQ: GLYC To the extent that statements contained in this presentation are not descriptions of historical facts, thr statements reflecting the current beliefs and expectations of the management of GlycoMimetics, Inc. | "us," or "our"). Forward-looking statements contained in this presentation may include, but are not lin or projected timing of events, data readout and data ana ...
GlycoMimetics(GLYC) - 2023 Q4 - Annual Results
2024-03-27 13:00
EXHIBIT 99.1 GlycoMimetics Reports Highlights and Financial Results for Fourth Quarter and Full Year 2023 ROCKVILLE, Md.--(BUSINESS WIRE) – March 27, 2024-- GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today reported its financial results and highlights for the quarter and year ended December 31, 2023. Cash and cash equivalents as of December 31, 2023, were $41.8 million. "With t ...
GlycoMimetics(GLYC) - 2023 Q4 - Annual Report
2024-03-27 12:25
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, 2023 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) - 2023 Q3 - Quarterly Report
2023-11-03 12:31
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 September 30, 2023 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 (Stat ...
GlycoMimetics(GLYC) - 2023 Q2 - Quarterly Report
2023-08-02 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 June 30, 2023 OR (I.R.S. Employer Identification No.) (240) 243-1201 ☐ 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. (Registrant's telephone number, i ...
GlycoMimetics(GLYC) - 2023 Q1 - Quarterly Report
2023-05-03 12:34
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, 2023 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) - 2022 Q4 - Earnings Call Transcript
2023-03-29 15:09
Financial Data and Key Metrics Changes - As of December 31, 2022, GlycoMimetics had cash and cash equivalents of $47.9 million, down from $90.3 million as of December 31, 2021 [11] - Expenses for the second half of 2022 decreased to $19.2 million compared to $30.4 million in the first half of 2022 [11] - Research and development expenses decreased to $5.9 million for Q4 2022 from $12.9 million in Q4 2021, primarily due to lower global Phase III clinical study costs [11] - General and administrative expenses increased to $4.7 million for Q4 2022 from $4.5 million in Q4 2021, mainly due to higher pre-commercial expenses for uproleselan [11] Business Line Data and Key Metrics Changes - The pivotal Phase III study of uproleselan in relapsed/refractory AML continues to show promising results, with a median follow-up of over 25 months [7] - The transplant rate in the study is above the 31% rate observed in the preceding Phase I/II trial, with a low patient dropout rate of about 3% [9] Market Data and Key Metrics Changes - The company completed a financing round in February 2023, raising $32.9 million, which is expected to extend the cash runway to the end of 2024 [12][23] - The study is on track to have the longest follow-up of any study in relapsed/refractory AML at the point of primary analysis, potentially exceeding three years [23][25] Company Strategy and Development Direction - The company is focused on strengthening its leadership team, sustaining clinical progress for uproleselan, and raising capital for continued trials [6] - GlycoMimetics aims to evolve into a commercial stage company capable of delivering important new medicines to patients [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the interim analysis of the Phase III study, which found no safety concerns and recommended continuing to the final analysis [12] - The company remains focused on delivering new options to patients waiting for better standard care therapies for AML [25] Other Important Information - The interim analysis employed a high statistical threshold to preserve the integrity of the final analysis, with no safety concerns noted [24] - The company is engaging with the medical community to raise awareness of uproleselan's unique mechanism of action [32] Q&A Session Summary Question: When do you expect data for the NCI sponsored trial to come out? - Management indicated that there has been no official update from NCI, and it is reasonable to assume that data may be delayed similar to the Phase III study [14] Question: What is the status of GMI-1687? - The company is currently focused on uproleselan and is open to partnerships for GMI-1687 but is not actively pursuing a Phase I trial at this time [29] Question: How does the statistical team predict the event timing? - The statistical team has developed a robust projection tool considering various patient characteristics, and updated projections indicate the full event trigger is expected in H1 2024 [31]
GlycoMimetics(GLYC) - 2022 Q4 - Annual Report
2023-03-29 12:31
Drug Development and Clinical Trials - The company is developing uproleselan, a specific E-selectin antagonist, for treating acute myeloid leukemia (AML) and has received Breakthrough Therapy designation from the FDA[19]. - In a Phase 1/2 trial, uproleselan demonstrated a 69% rate of minimal residual disease negativity in evaluable participants with relapsed/refractory AML[23]. - The company completed enrollment of 388 patients in a Phase 3 pivotal clinical trial for uproleselan in relapsed/refractory AML, with an interim analysis planned based on 80% of survival events[24][26]. - GMI-1687, an innovative antagonist of E-selectin, has shown equivalent activity to uproleselan at an approximately 1,000-fold lower dose in animal models[28]. - The company anticipates reaching the overall survival events trigger for the Phase 3 trial in the first half of 2024, with top line data disclosure expected soon thereafter[26]. - Uproleselan is in a Phase 3 clinical trial for relapsed/refractory acute myeloid leukemia (AML) with 388 patients enrolled across multiple countries, expecting overall survival event trigger in the first half of 2024[34]. - Uproleselan demonstrated improved chemotherapy sensitivity in preclinical studies, reducing tumor burden in AML models[54][57]. - Uproleselan demonstrated a complete remission (CR) rate of 41% and a median overall survival (OS) of 8.8 months in the relapsed/refractory acute myeloid leukemia (R/R AML) cohort[66]. - In the newly diagnosed AML cohort, the CR rate was 72% with a median OS of 12.6 months, significantly better than historical controls which reported event-free survival (EFS) of 2.0-6.5 months[66]. - The ongoing Phase 3 trial for uproleselan has enrolled 388 patients, with an interim analysis planned to assess overall survival events in the first half of 2024[69]. - The Phase 1 trial of uproleselan in healthy volunteers indicated good tolerability and pharmacokinetics consistent with preclinical data[61]. - The company is collaborating with the NCI on a Phase 2/3 trial for uproleselan in older adults with untreated AML, aiming to enroll approximately 670 patients[70]. - GMI-1687 received FDA clearance for investigational new drug application in June 2022, targeting vaso-occlusive crisis in sickle cell disease[29]. - The China National Medical Products Administration granted IND approval for uproleselan, enabling the initiation of a Phase 1 PK and tolerability study, and a Phase 3 bridging study in combination with chemotherapy for relapsed/refractory AML[81]. Financial Performance and Projections - The company has incurred significant losses since inception and expects to continue incurring losses over the next several years[12]. - As of December 31, 2022, the company had an accumulated deficit of $419.6 million[180]. - The company expects to continue incurring significant expenses and operating losses over the next several years[181]. - The company anticipates that expenses will increase substantially and negative cash flows from operating activities will continue over the next 12 months[181]. - The company has financed operations through public offerings and collaboration agreements, focusing on research and development[180]. - The company expects significant fluctuations in financial condition and operating results due to various uncontrollable factors[196]. - The company anticipates that raising additional capital may cause dilution to stockholders and restrict operations[190]. - The company’s ability to generate revenue from uproleselan is contingent on Apollomics achieving development, regulatory, and commercial milestones, which are largely out of the company's control[183]. Regulatory Environment - The company is subject to extensive government regulation, requiring substantial time and financial resources for obtaining regulatory approvals and compliance[102][103]. - The FDA requires completion of preclinical studies, including laboratory tests and animal studies, before an IND can be submitted[105]. - An IND becomes effective 30 days after submission unless the FDA raises concerns, which can delay clinical trials[104]. - Approval of an NDA requires satisfactory completion of FDA inspections of manufacturing facilities and clinical trial sites[117]. - The FDA may grant expedited review programs, such as fast track designation and priority review, to drugs addressing serious conditions[120][122]. - Post-approval, drugs are subject to ongoing FDA regulation, including requirements for recordkeeping and reporting adverse experiences[127]. - The FDA may withdraw approval if compliance with regulatory requirements is not maintained after market entry[130]. - Manufacturers must continue to comply with cGMP requirements and may face inspections to ensure adherence[129]. - The FDA restricts marketing of drugs to approved indications, and violations can lead to significant liability[133]. Market and Competitive Landscape - The competitive landscape includes several therapies approved for AML treatment, with significant competition from companies with greater financial resources and expertise[99][101]. - The future commercial success of drug candidates depends on adequate reimbursement levels from governmental and private payors[146]. - Third-party payors are increasingly imposing restrictions on coverage and reimbursement levels, influencing healthcare product purchases[147]. - Legislative proposals to reform healthcare may result in lower reimbursement rates or exclusion of drugs from coverage[148]. - The PPACA established an annual fee on entities manufacturing specified branded prescription drugs, impacting profitability[151]. - The Inflation Reduction Act of 2022 will eliminate the Medicare Part D "donut hole" starting in 2025, affecting drug pricing strategies[152]. - There is increasing legislative interest in drug pricing practices, with potential reforms aimed at enhancing transparency and controlling costs[153]. - State legislatures are implementing regulations to control pharmaceutical pricing, including price constraints and marketing cost disclosures[154]. Intellectual Property and Licensing - The company has issued patents covering uproleselan and GMI-1687, with expiration dates expected between 2032 and 2042, and is actively seeking to expand its intellectual property estate[84][87]. - The company plans to seek licensing partners for GMI-1359 and expand the use of E-selectin antagonists in select territories[34][41]. - The company entered into an exclusive collaboration and license agreement with Apollomics for the development and commercialization of uproleselan and GMI-1687 in Greater China, receiving an upfront cash payment of $9.0 million and potential milestone payments totaling approximately $180.0 million[79]. - Apollomics is responsible for all clinical development and commercialization activities in Greater China, while the company retains all rights for both compounds in the rest of the world[79]. - The company has established a joint development committee with Apollomics to oversee activities under the collaboration and license agreement[82]. Operational Challenges - The company relies on third parties for clinical trials and manufacturing, which increases risks related to timely and sufficient production of drug candidates[12]. - The company does not have manufacturing facilities and relies on third parties for the manufacturing of its drug candidates, expecting a significant increase in manufacturing if marketing approval is received for uproleselan[91]. - The company faces potential disruptions in its supply chain due to government orders and restrictions, which could impact third-party manufacturing facilities in the United States and other countries[208]. - Manufacturing supply interruptions of uproleselan, currently produced in Switzerland and China, may adversely affect ongoing and future clinical trials[208]. Employee and Organizational Structure - The company has 39 employees, with no representation by labor unions[172]. - The company aims to attract and retain high-performing employees through equity-based compensation awards[173].
GlycoMimetics(GLYC) - 2022 Q3 - Earnings Call Transcript
2022-11-09 16:10
GlycoMimetics, Inc. (NASDAQ:GLYC) Q3 2022 Earnings Conference Call November 9, 2022 8:30 AM ET Company Participants Christian Dinneen-Long - Company Counsel Harout Semerjian - President and Chief Executive Officer Brian Hahn - Senior Vice President and Chief Financial Officer Bruce Johnson - Senior Vice President and Chief Commercial Officer Edwin Rock - Chief Medical Officer Conference Call Participants Edward White - H.C. Wainwright Operator Good morning and thank you for joining the GlycoMimetics Q3 2022 ...