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GI

GLYCOMIMETICS INC (GLYC)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 was dominated by the Phase 3 topline readout: uproleselan plus chemotherapy did not achieve a statistically significant OS benefit versus placebo, with median OS of 13.0 months vs 12.3 months in control; management is conducting a comprehensive analysis and will present at an upcoming medical meeting .
  • Preliminary financial updates: cash and equivalents fell to $31.3M from $41.8M in Q4 2023; R&D rose to $6.0M on raw material acquisition, while G&A decreased to $5.1M on lower personnel and consulting costs .
  • The NCI Phase 2/3 frontline AML study remains ongoing; Phase 2 EFS interim will be reported when available, and the EFS trigger had not been reached as of March engagement with NCI .
  • Management signaled cash conservation and priority focus on deep analysis of 301 (uproleselan) and regulatory engagement; prior NDA-by-2024 conditional plan is now being evaluated given the Phase 3 outcome .
  • Street consensus comparisons for Q1 2024 EPS/revenue were unavailable via S&P Global for GLYC at the time of analysis; no formal Q1 EPS/revenue were disclosed in the preliminary release .

What Went Well and What Went Wrong

What Went Well

  • Management quickly communicated topline results and outlined plans to analyze the full dataset with medical, statistical, and regulatory experts and submit for presentation at an upcoming medical meeting .
  • Safety profile was consistent with known side effects of the chemotherapies used, supporting tolerability in the study setting .
  • Frontline NCI Phase 2/3 study continues, preserving a potential path in a different AML population and regimen; company reiterated intent to share EFS interim when available .
  • Quote: “We are thoroughly analyzing the data… and are committed to submitting a comprehensive data analysis for presentation at an upcoming medical meeting.” — CEO Harout Semerjian .

What Went Wrong

  • The pivotal Phase 3 R/R AML study did not meet the primary endpoint (OS in ITT), eliminating the near-term NDA pathway that had been contingent on a positive outcome .
  • Control arm median OS was unusually high (12.3 months), compressing the observed treatment effect and contributing to failure to achieve statistical significance; this extended event timing also delayed readout .
  • Cash decreased sequentially, reflecting ongoing burn; management indicated potential cash conservation measures and priority reallocation post-readout .

Financial Results

Key P&L, Cash, and Share Metrics

MetricQ3 2023Q4 2023Q1 2024
Revenue ($USD Thousands)$0 $10 — (not disclosed in preliminary release)
Net Loss ($USD Thousands)$(9,203) $(9,079) — (not disclosed)
Diluted EPS ($USD)$(0.14) $(0.14) — (not disclosed)
R&D Expense ($USD Millions)$5.292 $5.289 $6.0 (raw material acquisition)
G&A Expense ($USD Millions)$4.522 $4.312 $5.1 (lower personnel/consulting vs prior year)
Cash and Equivalents ($USD Millions)$49.408 $41.793 $31.3
Shares Outstanding64,368,843 64,393,744 64,450,835

Notes:

  • Q1 2024 preliminary press release did not include revenue/EPS; the previously scheduled Q1 financial results call was replaced by the May 6 call focused on topline trial results .

Clinical Outcome KPIs (R/R AML Phase 3 and Program)

KPIQ3 2023Q4 2023Q1 2024
Pivotal Phase 3 Enrollment388 patients (completed) 388 patients 388 randomized across 70 sites in 9 countries
Primary Endpoint ResultPending (expected Q2 2024) Pending (median follow-up >3 years) Did not meet OS primary endpoint (ITT)
Median OS (Treatment vs Placebo)——13.0 vs 12.3 months
Discontinuation/Lost to Follow-up——~3%
NCI Phase 2/3 (Frontline AML ≥60, fit for 7+3)Ongoing; Phase 2 enrolled 267 Ongoing; EFS interim to be reported when available EFS trigger not reached as of March engagement; ongoing

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Uproleselan NDA Timing (R/R AML)2024File NDA by end-2024 if Phase 3 positive Evaluating in light of Phase 3 miss; plan to analyze data and discuss with FDA Lowered
Financial GuidanceFY 2024Not specifiedManagement evaluating financial guidance; focus on conserving cash and prioritizing 301 analysis Updated/Under review
Q1 2024 Financial Results CallQ1 2024Scheduled for May 9, 2024 Replaced by May 6 call focused on topline results Changed

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023)Previous Mentions (Q4 2023)Current Period (Q1 2024)Trend
Regulatory/Legal (NDA Path)Anticipated NDA by end-2024 pending positive Phase 3 Reiterated potential NDA timeline if outcome positive Will discuss data with FDA; analyzing full dataset post miss Shift from anticipated filing to evaluation post-miss
R&D Execution (Phase 3 design and timing)Time-based OS analysis added; topline expected by end-Q2 2024 Median follow-up >3 years; expecting Q2 topline OS primary endpoint not met; control arm OS unusually high; comprehensive analysis planned From momentum to reassessment
Product Performance (Uproleselan efficacy)Positive expectations, external data presentations planned Emphasized trial maturity and potential utility Median OS 13.0 vs 12.3 months; no statistical significance Negative topline outcome
NCI Frontline StudyInterim EFS planned (267 patients) Will report when available EFS trigger not reached as of March; ongoing Continuing; potential future catalyst
Cash/OpExCash $49.4M; R&D $5.3M; G&A $4.5M Cash $41.8M; R&D $5.3M; G&A $4.3M Cash $31.3M; R&D $6.0M; G&A $5.1M; prioritizing cash conservation Sequential cash decline; tighter spend focus

Management Commentary

  • Strategic Focus: “We are diligently and rapidly evaluating the full data set with medical, statistical and regulatory experts and we plan to share further updates as appropriate… and are developing a plan to discuss these data with the FDA given the significant unmet patient need.” — CEO Harout Semerjian .
  • Trial Context: “Patients treated with uproleselan had a median overall survival of 13 months compared to 12.3 months in the placebo arm. The control group median survival of over 1 year is unprecedented in a randomized trial of therapy for relapsed and refractory AML.” — CMO Edwin Rock .
  • Cash Prioritization: “We’re going to be looking at ways to conserve cash and really focus on deepening our understanding of what's going on with 301 and really work closely with regulatory partners…” — CEO Harout Semerjian .

Q&A Highlights

  • Drivers of High Control OS and Timing: Management noted longer-than-anticipated survival extended the readout timing; the control arm median OS (~12.3–12.5 months) was “probably one of the highest” known in R/R AML studies, necessitating further analysis of underlying drivers .
  • NCI Frontline Study Impact: Company does not see a strong read-through given different line of therapy, backbone, and endpoint; will discuss with NCI and await EFS data .
  • Subgroup Analyses: While the study was not powered for subgroups, stratification factors (age, disease status, backbone) exist; a comprehensive review of subgroup outcomes will be conducted .
  • Regulatory Engagement: Too early to speculate on filings limited to subpopulations; prior constructive FDA interactions acknowledged and further engagement planned following deeper analysis .

Estimates Context

  • Wall Street consensus (S&P Global) for Q1 2024 EPS/revenue was unavailable for GLYC in our dataset at the time of analysis; the Q1 preliminary release also did not disclose EPS or revenue for comparison .
  • Given the absence of reported Q1 EPS/revenue and unavailable consensus, estimate-based beats/misses cannot be assessed this quarter .

Key Takeaways for Investors

  • Near-term regulatory path in R/R AML is uncertain after the Phase 3 miss; the thorough data analysis and FDA discussions are the key narrative drivers in the next 1–2 quarters .
  • The unusually strong control arm OS likely compressed the observed treatment effect; watch for subgroup/depth-of-remission, MRD, and transplant analyses that could inform any targeted path forward .
  • Frontline NCI study remains a potential catalyst; EFS interim could provide differentiation in a different setting and regimen .
  • Cash fell to $31.3M; management indicated cash conservation and prioritization of 301 analysis—monitor for operating runway updates and any strategic actions .
  • R&D increased on raw material acquisition for future manufacturing batches; expect OpEx discipline and updated guidance post strategic review .
  • Without Q1 EPS/revenue disclosure and unavailable consensus, trading setups will hinge more on clinical narrative and upcoming data presentations than on near-term fundamentals .
  • The company’s broader pipeline (GMI-1687 in SCD) remains intact; any redeployment of resources toward programs outside AML could evolve with the strategic review .