GlycoMimetics(GLYC) - 2024 Q2 - Quarterly Report

Drug Development and Clinical Trials - The lead glycomimetic drug candidate, uproleselan, showed a median overall survival of 13.0 months in the treatment arm compared to 12.3 months in the placebo arm, but the difference was not statistically significant [64]. - In the subgroup of primary refractory patients, the median overall survival for those treated with uproleselan was 31.2 months compared to 10.1 months for the placebo group, indicating a significant benefit [66]. - A Cooperative Research and Development Agreement with the National Cancer Institute is ongoing for a Phase 2/3 trial of uproleselan, with enrollment of 267 patients completed in December 2021 [67]. - GMI-1687, an innovative antagonist of E-selectin, is being developed for vaso-occlusive events in sickle cell disease, with a Phase 1a trial completed in December 2023 [68]. - The Phase 3 trial of uproleselan did not achieve a statistically significant improvement in overall survival in the intent to treat population [64]. - The Phase 3 bridging study for uproleselan completed enrollment with 140 adult patients across 20 sites in Greater China, focusing on overall survival as the primary endpoint [73]. - The company has suspended a project agreement for the manufacture and supply of injectable uproleselan and has no binding obligation to acquire the product [94]. - The company has initiated the closure of all clinical sites and will incur close-out costs [94]. Financial Performance and Expenses - The company reported an accumulated deficit of $478.3 million as of June 30, 2024, and continues to incur operating losses [69]. - The company reported a net loss of$10.1 million for the three months ended June 30, 2024, compared to a net loss of $8.3 million in the same period in 2023, representing an increase of$1.8 million (22%) [85]. - Total costs and expenses for the three months ended June 30, 2024, were $10.4 million, an increase of$1.4 million (16%) from $8.9 million in the same period in 2023 [85]. - Research and development expenses for the three months ended June 30, 2024, increased by$2.2 million (54%) to $6.3 million compared to$4.1 million in the same period in 2023 [85]. - For the six months ended June 30, 2024, research and development expenses rose by $2.8 million (30$12.3 million from $9.5 million in the same period in 2023 [86]. - General and administrative expenses decreased by$0.8 million (16%) for the three months ended June 30, 2024, and by $1.2 million (12$409,000 (61%) to $262,000 compared to$671,000 in the same period in 2023 [85]. - Interest income decreased by $0.4 million (for three months) and$0.6 million (for six months) due to lower invested cash and cash equivalent balances compared to the same periods in 2023 [89]. - The company incurred a net loss of $36.9 million during 2023 [99]. Strategic Initiatives and Future Outlook - Following the Phase 3 trial results, the company initiated a strategic review process, which may include a merger, sale, or other strategic transactions [70]. - A workforce reduction plan was implemented, reducing the workforce by approximately 80$28.7 million [91]. - Net cash used in operating activities for the six months ended June 30, 2024, was $19.4 million, compared to$18.6 million for the same period in 2023 [100]. - Net cash provided by financing activities during the six months ended June 30, 2024, consisted of proceeds from stock option exercises, while in 2023, it was primarily from sales of common stock [103]. Collaboration and Revenue - The company has entered into a collaboration with Apollomics for the development of uproleselan and GMI-1687 in Greater China [72]. - The company recognized $1.1 million in revenue from clinical supplies sold to Apollomics during the year ended December 31, 2021, but reported no sales during the six months ended June 30, 2024, or 2023 [74]. - The company has not generated any revenue from drug sales to date and does not expect to do so in the near future, relying primarily on upfront and milestone payments from collaboration agreements [77]. - The company received an upfront cash payment of$9.0 million and a $1.0 million milestone payment in September 2020, with potential further milestone payments totaling approximately$179.0 million and tiered royalties ranging from high single digits to 15% of net sales [73].