Sign in

You're signed outSign in or to get full access.

IP

Inozyme Pharma, Inc. (INZY)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 was steady operationally with continued R&D execution and a sequential improvement in net loss vs Q2 ($24.6M vs $27.0M) and EPS (-$0.39 vs -$0.44), supported by lower R&D and G&A .
  • Cash, cash equivalents, and investments were $131.6M, with runway “into the fourth quarter of 2025,” unchanged from prior quarter guidance .
  • The company highlighted positive calciphylaxis Phase 1 interim data (SEAPORT 1) showing PPi normalization by week 3 and plans for a 2025 registrational trial, subject to regulatory alignment and funding—key near-term catalysts alongside ENERGY 1 interim data for ENPP1 infants by year-end .
  • Notably, guidance for ENERGY 3 topline moved from 2H 2025 to “early 2026,” indicating a timeline extension for the pediatric ENPP1 pivotal program; complete enrollment shifted from Q3 2024 to “end of 2024” .

What Went Well and What Went Wrong

What Went Well

  • Calciphylaxis: INZ-701 significantly increased PPi levels into the normal range by week 3 in ESKD patients on hemodialysis; safety profile was favorable—foundational for a registrational trial in 2025, pending alignment and funding .
  • Liquidity and runway: $131.6M cash/equivalents; runway “into Q4 2025” maintained, supporting continued development across programs .
  • Management focus and program breadth: “Our focus remains firmly on advancing INZ-701 across each of our clinical programs,” emphasizing growing clinical evidence across multiple indications of high unmet need .

What Went Wrong

  • Timeline slippage: ENERGY 3 topline moved to early 2026 (from 2H 2025); enrollment completion pushed from Q3 2024 to end of 2024—extends time to pivotal readout and potential value inflection point .
  • YoY P&L: Net loss widened to $24.6M (vs $16.6M), driven by higher R&D ($19.9M vs $13.3M) as clinical activity expanded .
  • Funding dependency: Initiation of registrational trials in calciphylaxis and ABCC6 in 2025 explicitly conditioned on regulatory alignment and sufficient funding—an ongoing overhang for timelines .

Financial Results

Quarterly P&L and Liquidity (oldest → newest)

MetricQ1 2024Q2 2024Q3 2024
Net Loss ($USD Millions)$23.347 $27.033 $24.570
Net Loss per Share ($USD)$0.38 $0.44 $0.39
R&D Expense ($USD Millions)$19.111 $21.758 $19.890
G&A Expense ($USD Millions)$5.234 $5.907 $4.961
Total Operating Expenses ($USD Millions)$24.345 $27.665 $24.851
Cash, Cash Equivalents & Investments ($USD Millions)$166.153 $144.523 $131.608
Weighted-Average Shares (Millions)61.772 61.944 63.277

Note: Company did not report product revenue; statements are operating-expense based (pre-commercial) .

YoY Comparison (Q3 2023 vs Q3 2024)

MetricQ3 2023Q3 2024
Net Loss ($USD Millions)$16.638 $24.570
Net Loss per Share ($USD)$0.29 $0.39
R&D Expense ($USD Millions)$13.341 $19.890
G&A Expense ($USD Millions)$4.733 $4.961
Total Operating Expenses ($USD Millions)$18.074 $24.851

Consensus vs Actual (Q3 2024)

MetricQ3 2024 ActualQ3 2024 Consensus
EPS ($USD)-$0.39 N/A – S&P Global consensus unavailable
Revenue ($USD Millions)N/AN/A – S&P Global consensus unavailable

KPIs (Calciphylaxis SEAPORT 1 interim—PPi levels)

TimepointMean PPi (nM) ± SEM
Baseline–Day 3 pre-dose619 ± 74
Day 10 pre-dose931 ± 255
Day 17 pre-dose1,498 ± 224
Day 24 pre-dose1,551 ± 270

Healthy subjects showed PPi levels between 1,002–2,169 nM .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ENERGY 3 topline (pediatric ENPP1)Readout2H 2025 Early 2026 Lowered/Delayed
ENERGY 3 enrollment completion2024Q3 2024 End of 2024 Delayed
ENERGY 2 initiation (infants ENPP1, ex-U.S.)Q4 2024Q4 2024 Q4 2024 Maintained
Calciphylaxis registrational initiation2025Not previously specified (Q2 focused on interim data Q4 2024) 2025 (subject to regulatory and funding) New/Specified
ABCC6 pediatric pivotal initiation2025Q1 2025 (subject to regulatory and funding) 2025 (subject to regulatory and funding) Maintained (less specific)
Cash runwayLiquidityInto Q4 2025 Into Q4 2025 Maintained

Earnings Call Themes & Trends

Note: No earnings call transcript found; themes based on Q1/Q2 press materials and Q3 earnings release.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Calciphylaxis (SEAPORT 1)Interim data planned Q4 2024 Positive interim data; PPi normalization by week 3; plan to initiate registrational trial in 2025 (pending alignment/funding) Strengthening momentum
ENPP1 infants (ENERGY 1)Interim data 2H 2024 / Q4 2024 On track for interim data by year-end Maintained
Pediatric ENPP1 (ENERGY 3)Topline mid-2025 / 2H 2025 Topline early 2026; enrollment completion by end of 2024 Delayed
ABCC6 pediatric pivotalInitiation Q1 2025, subject to alignment/funding Initiation in 2025, subject to alignment/funding Maintained
Regulatory pathwayFDA Fast Track for ABCC6 (July) Continued regulatory alignment focus in calciphylaxis and ABCC6 Improving optionality
Liquidity/runwayInto Q4 2025 Into Q4 2025 Stable

Management Commentary

  • “As we close in on the end of a highly productive year, our focus remains firmly on advancing INZ-701 across each of our clinical programs.” — Douglas A. Treco, Ph.D., CEO & Chairman .
  • “The interim data from the SEAPORT 1 trial demonstrate that INZ-701 significantly raised PPi levels in patients with end-stage kidney disease and was well-tolerated…” — Douglas A. Treco, Ph.D., CEO & Chairman .
  • “There is an urgent unmet need… These new data underscore the significant and multifaceted impact of ENPP1 and ABCC6 Deficiencies…” — Kurt Gunter, M.D., Chief Medical Officer, on ASBMR data .

Q&A Highlights

  • No earnings call transcript available; no Q&A session found in the document set [ListDocuments: none for earnings-call-transcript].

Estimates Context

  • S&P Global consensus estimates for Q3 2024 EPS and revenue were unavailable for INZY via the SPGI integration. Where estimates comparisons would ordinarily be shown, values are marked N/A (S&P Global consensus unavailable).
  • Actual EPS was -$0.39 for Q3 2024 .

Key Takeaways for Investors

  • Near-term catalysts: ENERGY 1 interim data (infants ENPP1) by year-end and calciphylaxis registrational trial plans for 2025—potential stock reaction drivers given first clinical signals in ESKD .
  • Program breadth de-risks single-asset risk profile (ENPP1, ABCC6, calciphylaxis) but timelines are extended for pediatric ENPP1 (ENERGY 3 topline now early 2026) .
  • Operating discipline: sequential improvement in net loss and EPS vs Q2 on lower R&D and G&A; expect variability as pivotal programs ramp .
  • Liquidity runway into Q4 2025 supports planned clinical execution; pivotal initiations remain subject to alignment and funding—monitor capital strategy and potential partnerships .
  • Calciphylaxis PPi data are compelling mechanistically; watch for regulatory feedback and study design specifics to assess path to approval risk .
  • ENPP1/ABCC6 data dissemination at ASBMR and Fast Track status bolster scientific/regulatory narrative; however, pediatric timelines require patience and careful expectation management .
  • With consensus estimates unavailable, trading setups should anchor on clinical catalysts and runway rather than near-term earnings variability; the narrative that moves the stock is clinical progress and regulatory clarity .

Sources: Q3 2024 8-K and press release, plus related company press releases and data cited above .