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GI

GLYCOMIMETICS INC (GLYC)·Q4 2023 Earnings Summary

Executive Summary

  • Q4 2023 showed minimal revenue ($10K) and a narrower net loss year over year (net loss of $9.08M vs. $10.25M in Q4 2022), with EPS of $(0.14) and continued disciplined OpEx management .
  • Management reaffirmed timing for the pivotal R/R AML Phase 3 topline readout in Q2 2024 and reiterated the plan to submit an NDA by year-end 2024 if results are positive—key catalysts for the stock narrative .
  • Cash and cash equivalents were $41.8M at 12/31/2023, and the company stated a cash runway through year-end 2024 to support data readout and potential NDA submission .
  • GMI-1687 Phase 1a met primary and secondary endpoints; ASH Research Collaborative partnership announced to inform clinical development in sickle cell disease, supporting pipeline breadth .
  • The call emphasized clinical maturity of the dataset (median follow-up >3 years; majority of transplanted patients >2 years post-transplant), bolstering confidence ahead of Q2 data .

What Went Well and What Went Wrong

What Went Well

  • Clinical momentum: “We are laser-focused on delivering the topline results in Q2 and excited about the possibility of submitting an NDA before year-end” (CEO) .
  • Pipeline progress: GMI-1687 Phase 1a achieved safety/tolerability and PK endpoints; no dose-limiting toxicities and potentially therapeutic plasma levels after a single injection .
  • Commercial readiness and cash runway: “Our disciplined approach… provides a current cash runway through year-end 2024,” and prelaunch activities expanded ahead of potential approval (CEO) .

What Went Wrong

  • Persistent losses and no product revenue: Q4 revenue was $10K while net loss was $9.08M; EPS remained negative at $(0.14) .
  • Timeline dependence on clinical outcomes: Execution risk remains concentrated in the pivotal uproleselan readout and subsequent regulatory review (management reiterated blinded status and time-based analysis necessity) .
  • Limited external financial guidance: No numeric revenue/EPS guidance, and consensus estimates via S&P Global were unavailable for GLYC in Q4 2023 (attempted retrieval; mapping not found).

Financial Results

P&L and EPS vs. Prior Quarters and Year-over-Year

MetricQ2 2023Q3 2023Q4 2023
Revenue ($USD Thousands)$0 $0 $10
Net Loss ($USD Thousands)$(8,259) $(9,203) $(9,079)
EPS (Basic & Diluted) ($USD)$(0.13) $(0.14) $(0.14)
R&D Expense ($USD Thousands)$4,073 $5,292 $5,289
G&A Expense ($USD Thousands)$4,857 $4,522 $4,312
MetricQ4 2022Q4 2023
Revenue ($USD Thousands)$0 $10
Net Loss ($USD Thousands)$(10,245) $(9,079)
EPS (Basic & Diluted) ($USD)$(0.19) $(0.14)

Balance Sheet and Liquidity KPIs

MetricQ2 2023Q3 2023Q4 2023
Cash & Cash Equivalents ($USD Thousands)$58,037 $49,408 $41,793
Working Capital ($USD Thousands)$53,797 $45,619 $36,956
Total Assets ($USD Thousands)$61,822 $53,201 $45,316
Total Liabilities ($USD Thousands)$7,021 $6,653 $6,902
Stockholders’ Equity ($USD Thousands)$54,801 $46,548 $38,414
Shares Outstanding (Units)64,313,333 64,368,843 64,393,840

Segment breakdown: Not applicable; GLYC has no commercial segments reported .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
R/R AML Phase 3 topline readout timingQ2 2024“By end of Q2 2024” (Q3 PR) “Q2 2024” (Q4 PR) Maintained
Uproleselan NDA filing (pending positive pivotal)FY 2024“Anticipated by end of 2024” (Q3 PR) “To be submitted by end of 2024 if outcome is positive” Maintained
GMI-1687 Phase 1a initial resultsQ1 2024“Expected by end of Q1 2024” (Q3 PR) Results achieved; met endpoints (Jan 2024) Achieved
Cash runwayThrough YE 2024Not previously disclosed“Cash runway through year-end 2024” New
ASH RC collaboration (GMI-1687)2024Not previously disclosedResearch agreement announced New

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2023 and Q3 2023)Current Period (Q4 2023)Trend
Trial maturity and timeline (R/R AML Phase 3)Time-based analysis added; topline by end of Q2 2024 Reaffirmed Q2 2024; median follow-up >3 years; majority of surviving transplanted patients ≥2 years post-transplant Confidence strengthened
Commercial readinessPreparing for potential regulatory filing/commercialization; higher G&A Expanded commercial/medical affairs; prelaunch activities underway Advancing
Pediatric developmentiPSP agreed (FDA); NCI pediatric Phase 1/2 initiated Children’s Oncology Group Phase I ongoing after first patient-in Oct; iPSP/PIP framework continued Progressing
GMI-1687 (SCD)Planned Phase 1a initiation Phase 1a met endpoints; ASH RC collaboration announced Positive inflection
Market opportunity narrativeLimited TAM detail previouslyU.S. R/R AML TAM estimated at $650–$850M; potential to more than double with frontline Newly articulated
Europe strategyNot highlightedPreparations underway; Europe to follow FDA focus Emerging

Management Commentary

  • CEO: “We are laser-focused on delivering the topline results in Q2 and excited about the possibility of submitting an NDA before year-end… [Phase 3] now has a median follow-up of more than three years… and could demonstrate the potential of uproleselan to become a new standard of care” .
  • CMO: “Survival events have continued to slow… we will proceed with a time-based analysis… median follow-up… over 3 years… a large majority… at least 2 years post-transplant… notable milestone because after 2 years post-transplant, disease relapse becomes infrequent” .
  • CCO: “We estimate… relapsed/refractory addressable market… more than 8,000 patients per year and… $650 million to $850 million in the U.S. alone… opportunity… over $4 billion U.S. market across the AML continuum” .
  • CFO: “R&D expenses decreased to $5.3M… G&A expenses decreased to $4.3M… cash and cash equivalents of $41.8M…” .

Q&A Highlights

  • Frontline integration and initial use: Management expects initial uptake as an adjunct to standard intensive chemotherapy, agnostic to mutation/cytogenetics, with potential expansion pending further data; frontline NCI trial is registrational-grade and may either connect or proceed in parallel depending on timing/data .
  • Timing and process for topline data: Data cutoff at March 31; teams will clean and lock database, with H1 Q2 timing emphasized (blinded to arms but events tracked; strong confidence in time-based analysis) .
  • ASH RC collaboration on SCD: Provides expert and patient feedback to co-create endpoints and improve trial execution feasibility in a challenging indication .
  • Clinical pharmacology: Exposure-response, exposure-toxicity, and population PK analyses included to meet FDA expectations for labeling .
  • Europe strategy: Planning underway; many Phase 3 sites in Europe, with regulatory engagement to follow U.S. focus .

Estimates Context

  • S&P Global Wall Street consensus for Q4 2023 revenue and EPS was unavailable for GLYC due to missing CIQ mapping (attempted retrieval failed). As a result, estimate comparisons cannot be provided for this quarter. Values would have been retrieved from S&P Global if available.

Key Takeaways for Investors

  • Binary near-term catalyst: The pivotal R/R AML Phase 3 topline readout in Q2 2024 and potential NDA submission by YE 2024 are primary drivers of the stock’s trajectory; management emphasized dataset maturity and confidence in the time-based analysis .
  • Commercial readiness is accelerating: Prelaunch build-out and medical affairs engagement position GLYC to move quickly upon a positive readout .
  • Liquidity supports milestones: $41.8M cash at year-end and stated runway through YE 2024 anchor execution capacity into data/NDA timing .
  • Pipeline optionality: GMI-1687’s positive Phase 1a and ASH RC collaboration provide a second shot-on-goal in SCD, adding value beyond AML .
  • TAM narrative strengthening: Management quantified U.S. R/R AML opportunity at $650–$850M, with potential frontline expansion, supporting medium-term commercialization potential if approved .
  • Risk remains concentrated in trial outcome: No product revenue, recurring losses, and reliance on a single pivotal dataset keep execution risk high until readout; there is no Street consensus available to benchmark Q4 results .
  • Post-readout strategy watch items: Regulatory interactions, EU pathway clarity, pricing/access strategy in hem-onc centers of excellence, and the pace of transplant-centered adoption will shape medium-term performance .

Appendix: Additional Prior-Quarter Highlights

  • Q3 2023: Cash $49.4M; R&D $5.3M; G&A $4.5M; reaffirmed topline by end of Q2 2024; iPSP agreed and PIP with EMA; COG pediatric trial ongoing .
  • Q2 2023: Cash $58.0M; R&D $4.1M; G&A $4.9M; time-based analysis option added for Phase 3; planned Phase 1a initiation for GMI-1687 .