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MBX Biosciences, Inc. (MBX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 was a pre‑revenue quarter with operating spend ramping for pipeline execution; net loss was $15.586M and diluted EPS was $−0.47 . Versus Wall Street consensus, EPS beat by $0.09 (consensus $−0.5646*) on no revenue (consensus $0*) — a modest beat driven primarily by higher interest income and share count normalization post‑IPO .*
  • Cash, cash equivalents and marketable securities were $262.149M at 12/31/2024, down from $277.063M at 9/30/2024; management reiterated cash runway into mid‑2027 .
  • Clinical execution advanced: enrollment completed (64 patients) in Phase 2 Avail trial of canvuparatide (MBX 2109) with topline expected Q3 2025; MBX 1416 Phase 1 topline was positive and Phase 2 in PBH is expected to start 2H 2025; IND for obesity candidate MBX 4291 remains on track for Q2 2025 .
  • Near‑term stock catalysts center on regulatory/clinical milestones (MBX 4291 IND filing; MBX 1416 Phase 2 initiation; canvuparatide Phase 2 topline), with EPS variance less relevant given no product revenue .

What Went Well and What Went Wrong

What Went Well

  • Completed enrollment of 64 HP patients in the randomized, double‑blind, placebo‑controlled 12‑week Phase 2 Avail trial of canvuparatide; topline results expected Q3 2025 .
  • Positive Phase 1 topline for MBX 1416 in healthy volunteers: generally well‑tolerated, dose‑proportional PK, ~90‑hour median half‑life supporting once‑weekly dosing, PD signal during mixed meal test; Phase 2 in PBH planned for 2H 2025 .
  • “MBX is entering 2025 with strong momentum following significant and transformational progress in 2024… poised to deliver Phase 2 clinical data… and well‑positioned to enter the clinic with our first obesity candidate later this year.” — President & CEO Kent Hawryluk .

What Went Wrong

  • Operating expenses increased sharply: R&D rose to $15.223M in Q4 (from $7.727M in Q4’23; $16.747M in Q3’24) driven by IND‑enabling work and Phase 2 trial costs; G&A rose to $3.387M in Q4 (from $2.264M in Q4’23; $2.865M in Q3’24) on personnel and infrastructure build‑out .
  • Net loss widened year‑over‑year to $15.586M (from $8.843M in Q4’23), albeit improved quarter‑over‑quarter vs Q3’24 in per‑share terms due to a larger average share count; absolute net loss remains driven by R&D ramp .
  • Cash declined sequentially to $262.149M at 12/31/2024 from $277.063M at 9/30/2024 as spend increased with pipeline progress; runway guidance unchanged (mid‑2027) .

Financial Results

MetricQ4 2023Q3 2024Q4 2024
Research & Development ($USD Millions)$7.727 $16.747 $15.223
General & Administrative ($USD Millions)$2.264 $2.865 $3.387
Total Operating Expenses ($USD Millions)$9.991 $19.612 $18.610
Interest & Other Income ($USD Millions)$1.148 $1.470 $3.024
Net Loss ($USD Millions)$(8.843) $(18.142) $(15.586)
Diluted EPS ($USD)$−7.74 $−2.78 $−0.47
Weighted Avg Shares (Basic & Diluted)1.143M 6.516M 33.393M
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$80.676 (12/31/2023) $277.063 (9/30/2024) $262.149 (12/31/2024)

Notes:

  • Year‑over‑year EPS comparability is impacted by pre‑IPO capital structure and share count normalization .
  • MBX remained pre‑revenue in Q4’24; no segment reporting applies .

Estimates vs Actuals (Q4 2024):

MetricConsensusActualBeat/Miss
EPS ($USD)−0.5646*−0.47 +$0.09 (beat)*
Revenue ($USD Millions)0.0*0.0 (pre‑revenue) In‑line*

Values retrieved from S&P Global.*

KPIs (pipeline and operating):

KPIQ4 2023Q3 2024Q4 2024
Canvuparatide (MBX 2109) Phase 2 Avail enrollment—Initiated; enrollment to complete Q1 2025 Enrollment completed; 64 patients
MBX 1416 Phase 1 status—Last subject last visit anticipated late Nov 2024 Positive topline; 69 subjects; once‑weekly PK; Phase 2 planned 2H 2025
MBX 4291 IND timing—IND Q2 2025 (on track) IND Q2 2025 (maintained)

Guidance Changes

MetricPeriodPrevious Guidance (Q3 2024)Current Guidance (Q4 2024)Change
Cash runwayMulti‑yearFund operations into mid‑2027 Fund operations into mid‑2027 Maintained
Canvuparatide (MBX 2109) Avail Phase 2 toplineQ3 2025Topline in Q3 2025 Topline in Q3 2025 Maintained
MBX 4291 (GLP‑1/GIP co‑agonist) IND filingQ2 2025Q2 2025 IND submission Q2 2025 IND submission Maintained
MBX 1416 Phase 2 initiation (PBH)2H 2025Phase 1 topline by Jan 2025; Phase 2 planned 2H 2025 Phase 1 topline positive; Phase 2 planned 2H 2025 Maintained/confirmed

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was available in the document set; themes derived from earnings press releases and related corporate updates.

TopicPrevious Mentions (Q3 2024)Current Period (Q4 2024 press release)Trend
R&D execution and OpEx driversR&D ramp tied to MBX 4291 IND‑enabling and MBX 2109 Phase 2; G&A up with infrastructure build R&D/G&A increases sustained; drivers consistent (IND‑enabling for MBX 4291; canvuparatide Phase 2) Continuing ramp tied to pipeline
Canvuparatide (HP)Phase 2 Avail initiated; enrollment to complete Q1 2025; topline Q3 2025 Enrollment completed (64 patients); topline Q3 2025 Progressing on schedule
MBX 1416 (PBH)Last subject last visit expected late Nov 2024; topline early Jan 2025 Positive Phase 1 topline; Phase 2 planned 2H 2025 Advancing to Phase 2
Obesity program (MBX 4291)IND‑enabling studies underway; IND expected Q2 2025 IND submission anticipated Q2 2025 On track
Capital position$277.1M cash at 9/30/2024; runway mid‑2027 $262.1M cash at 12/31/2024; runway mid‑2027 Strong, declining QoQ with spend

Management Commentary

  • “We are poised to deliver Phase 2 clinical data on our lead program in hypoparathyroidism, canvuparatide, with topline results… Additionally, we are well‑positioned to enter the clinic with our first obesity candidate later this year… [and] initiating a Phase 2 trial evaluating MBX 1416 in PBH in the second half of 2025.” — Kent Hawryluk, President & CEO .
  • “We are encouraged by the positive topline Phase 1 results… [MBX 1416] was generally well‑tolerated… ~90‑hour median half‑life supporting once‑weekly dosing… [with] an encouraging signal… to translate into a therapeutic benefit in PBH.” — Kent Hawryluk .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available; the company communicated via press releases. As a result, no Q&A themes or call‑based guidance clarifications can be extracted for Q4.

Estimates Context

  • Q4 2024 EPS was $−0.47 vs consensus $−0.5646 (beat of ~$0.09). Revenue was expected and reported at $0 given pre‑revenue status; consensus coverage was limited (2 estimates). Target price consensus mean stood at $64.43 with 7 covering analysts.*
  • With R&D elevated for MBX 4291 IND and canvuparatide Phase 2, 2025 OpEx and loss estimates may remain elevated until major clinical milestones read out; consensus may adjust timing around MBX 1416 Phase 2 start and canvuparatide Phase 2 topline.

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Execution continuity: canvuparatide Phase 2 enrollment completion and firm Q3 2025 topline guidance de‑risk near‑term program timing .
  • PBH asset momentum: MBX 1416’s positive Phase 1 (PK/PD and tolerability) supports Phase 2 initiation in 2H 2025, expanding optionality beyond HP .
  • Obesity entry catalyst: MBX 4291 IND expected in Q2 2025; once‑monthly GLP‑1/GIP prodrug positioning could be differentiated if clinical profile is favorable .
  • Balance sheet strength: $262.1M cash at 12/31/2024 and runway into mid‑2027 underpin multi‑asset development despite higher R&D spend .
  • EPS optics: Q4 EPS beat vs consensus is less indicative for valuation given pre‑revenue status and share count normalization; clinical/regulatory milestones remain the stock’s primary drivers .*
  • Watch list catalysts: MBX 4291 IND (Q2 2025), MBX 1416 Phase 2 initiation (2H 2025), canvuparatide Phase 2 topline (Q3 2025) .
  • Risk framing: Pipeline execution risks (trial outcomes, regulatory feedback) and continued OpEx ramp are core considerations; however, estimates sensitivity should focus on OpEx/interest income rather than revenue in the near term .

References: Q4 2024 8‑K earnings press release and selected financials ; Q3 2024 8‑K and financials ; MBX 1416 Phase 1 topline press release (Jan 7, 2025) .