GlycoMimetics(GLYC) - 2023 Q3 - Quarterly Report

Financial Position - The company has an accumulated deficit of $447.4 million as of September 30, 2023, and expects to continue incurring significant operating losses over the next several years[101]. - The company anticipates that existing cash and cash equivalents will fund operations into late Q4 2024, without considering potential business development opportunities[102]. - As of September 30, 2023, the company had $49.4 million in cash and cash equivalents[125]. - The company reported net cash used in operating activities of $27.3 million for the nine months ended September 30, 2023, compared to $38.5 million for the same period in 2022, indicating a reduction of approximately 29%[139]. - Net cash provided by financing activities during the nine months ended September 30, 2023, was $28.8 million, primarily from sales of common stock[142]. - The company has no significant capital expenditure requirements and no other fixed long-term obligations[130]. - The company anticipates that additional capital may be required beyond currently anticipated amounts, which may not be available on reasonable terms[137]. - The company has no committed external source of liquidity, except for amounts that may be sold under the 2022 Sales Agreement and potential milestone payments from Apollomics[133]. Drug Development - The lead drug candidate, uproleselan, is being evaluated in a Phase 3 clinical trial with 388 patients enrolled, targeting acute myeloid leukemia (AML) and potentially other hematologic cancers[88]. - The FDA has cleared a protocol amendment for the pivotal Phase 3 trial, allowing for a time-based analysis of overall survival, with topline results expected by the end of Q2 2024[91]. - A Cooperative Research and Development Agreement with the National Cancer Institute is in place for a Phase 2/3 trial testing uproleselan in combination with standard chemotherapy, with 267 patients enrolled in the Phase 2 portion[92]. - The company has initiated a Phase 1a trial for GMI-1687, an E-selectin antagonist, with approximately 40 subjects expected to be enrolled, and initial results anticipated by the end of Q1 2024[96]. - The company is advancing preclinical-stage programs, including GMI-2093, targeting galectin-3 for potential treatment of fibrosis, cancer, and cardiovascular disease[98]. - The company has terminated the development of GMI-1359 and is seeking a licensing partner for further clinical development[99]. - The company is uncertain about the timing and costs necessary to complete the development of its drug candidates, including uproleselan[132]. Revenue and Expenses - The company did not generate any revenue from drug sales during the three and nine months ended September 30, 2023, and recognized $75,000 in revenue during the same period in 2022[110][120]. - Research and development expenses for the three months ended September 30, 2023, increased by $369,000 (7%) compared to the same period in 2022, totaling $5,292,000[119][121]. - Research and development expenses for the nine months ended September 30, 2023, decreased by $7.7 million (34%) compared to the same period in 2022, totaling $14,783,000[119][121]. - General and administrative expenses for the three months ended September 30, 2023, increased by $677,000 (18%) compared to the same period in 2022, totaling $4,522,000[119][123]. - General and administrative expenses for the nine months ended September 30, 2023, increased by $545,000 (4%) compared to the same period in 2022, totaling $14,901,000[119][123]. - Interest income for the three months ended September 30, 2023, increased by $367,000 (150%) compared to the same period in 2022, totaling $611,000[119][124]. - Interest income for the nine months ended September 30, 2023, increased by $1.5 million (455%) compared to the same period in 2022, totaling $1,864,000[119][124]. Legal and Compliance - The company has not been involved in any material legal proceedings that could adversely affect its business or financial condition[148]. - The company has not recognized any material changes to its critical accounting policies and estimates since December 31, 2022[109].