GlycoMimetics(US:GLYC)2020-11-06 16:18Financial Data and Key Metrics Changes - As of September 30, 2020, GlycoMimetics had cash and cash equivalents of $142.9 million, down from $158.2 million as of December 31, 2019 [44] - Research and development expenses were $10.7 million for the third quarter of 2020, consistent with the same period in 2019, but decreased to $33.2 million for the nine months ended September 30, 2020, compared to $35.6 million for the same period in 2019 [45] - General and administrative expenses increased to $4.1 million for the third quarter of 2020, compared to $3.4 million for the same period in 2019 [48] Business Line Data and Key Metrics Changes - Enrollment in the pivotal Phase 3 trial evaluating uproleselan in patients with relapsed refractory acute myeloid leukemia (AML) continues according to plan, with expectations to complete enrollment in the second half of 2021 [11] - Emerging data from the Phase 3 RESET trial for rivipansel indicate significant improvements in time to readiness for discharge for patients treated early in acute vaso-occlusive crisis (VOC) [26][27] - Rivipansel received a rare pediatric disease designation from the FDA for the treatment of sickle cell disease in patients under 18 years of age [17] Market Data and Key Metrics Changes - The therapeutic options for patients with sickle cell disease have increased, but acute pain crises remain an area of high unmet need [19] - The pediatric subgroup in the RESET trial showed significant reductions in median time to readiness for discharge and discontinuation of IV opioids compared to placebo [31][32] Company Strategy and Development Direction - The company aims to complete enrollment in the Phase 3 trial of uproleselan and explore opportunities for developing therapies for acute VOC in sickle cell disease [10][11] - GlycoMimetics is evaluating the potential of GMI-1687 as a follow-on product candidate for treating acute VOC, emphasizing its suitability for outpatient and home treatment [21][42] - The company plans to present data from multiple compounds at the upcoming ASH meeting, highlighting the strength and relevance of their data [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical pipeline and the potential of GlycoMimetics' chemistry platform to improve standards of care in AML and sickle cell disease [52] - The company is optimistic about the combination of RESET data and GMI-1687 data, which may open new opportunities in sickle cell disease [58][59] Other Important Information - The company received a $1 million clinical development milestone from Apollomics related to the development of uproleselan and GMI-1687 in Greater China [44] - The favorable safety profile of rivipansel observed in the RESET trial strengthens its potential risk-benefit proposition [30] Q&A Session Summary Question: What information is needed to advance rivipansel? - Management indicated that they are evaluating data from the RESET study and will seek FDA input before making decisions on rivipansel and GMI-1687 [56][58] Question: What updates are available regarding uproleselan in Greater China? - Management stated that updates will be provided as the program progresses, with the next expected announcement being the start of the study in China [60] Question: What data will be available for GMI-1359 in the first half of 2021? - Initial data will focus on PKPD biomarkers and safety data, which may inform future expanded trials [64] Question: What feedback has been received from KOLs regarding rivipansel? - There is confidence among investigators that E-selectin inhibition is having a clinical effect, with excitement about the potential therapeutic candidate [79] Question: Will there be a partnership for the Upro plus HMA combination? - Management is exploring cost-effective ways to take the combination forward in the clinic and will provide updates as plans develop [81][84]