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PLIANT THERAPEUTICS, INC. (PLRX)·Q4 2024 Earnings Summary

Executive Summary

  • BEACON-IPF Phase 2b trial was discontinued after a prespecified review due to an imbalance in unadjudicated IPF-related adverse events versus placebo; management noted early evidence of efficacy on the FVC endpoint and will analyze full data to determine next steps .
  • Q4 2024 financials: net loss of $49.7M vs $41.1M YoY; EPS of $(0.82) vs $(0.69) YoY; sequentially improved EPS from $(0.95) in Q3 2024 as R&D expenses declined QoQ .
  • Cash, cash equivalents, restricted cash and short-term investments were $357.2M at 12/31/2024, down from $406.0M at 9/30/2024 and $438.1M at 6/30/2024; company communicated cash runway “for the next 12 months and beyond,” and forward-looking statements indicate runway into the second half of 2026, including access to the Oxford Loan Agreement .
  • S&P Global Wall Street consensus estimates for Q4 2024 EPS and revenue were unavailable at time of writing, so estimate beat/miss analysis cannot be performed (Values would be retrieved from S&P Global).

What Went Well and What Went Wrong

What Went Well

  • Early signals of efficacy: Company observed early FVC endpoint efficacy in BEACON-IPF despite discontinuation, indicating potential biological activity to be assessed with full data review .
  • Oncology pipeline progress: Phase 1 trial of PLN-101095 in solid tumors continues with dosing in the fourth of five cohorts; interim data from the first three cohorts expected in Q1 2025 .
  • Neuromuscular program step-up: PLN-101325 is Phase 1-ready with a CTA open in Australia, advancing from prior quarter exploration to trial readiness .
  • “We are pleased with the interest from the global physician and patient communities in participating in BEACON-IPF and look forward to sharing data in mid-2026.” — Bernard Coulie, CEO (Q3 2024) .
  • “The recent bexotegrast data releases in IPF and PSC have exceeded our expectations…demonstrate bexotegrast’s favorable long-term safety profile and strong antifibrotic effect across multiple indications.” — Bernard Coulie, CEO (Q2 2024) .

What Went Wrong

  • Pivotal program setback: BEACON-IPF Phase 2b discontinued following DSMB and outside expert panel recommendation due to adverse event imbalance, a significant development risk realization in the lead asset .
  • Higher operating expenses vs prior year and lower interest income pressured results: Net loss widened YoY to $49.7M; management attributed the increase to BEACON-IPF costs and reduced interest income on short-term investments .
  • Sequential cash burn: Liquidity declined to $357.2M at year-end from $406.0M at Q3 and $438.1M at Q2, reflecting continued R&D intensity and trial costs .

Financial Results

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Revenue ($USD Thousands)$— $— $— $—
Research and development ($USD Thousands)$(33,183) $(45,617) $(47,754) $(38,793)
General and administrative ($USD Thousands)$(13,854) $(15,022) $(14,260) $(14,527)
Total operating expenses ($USD Thousands)$(47,037) $(60,639) $(62,014) $(53,320)
Loss from operations ($USD Thousands)$(47,037) $(60,639) $(62,014) $(53,320)
Interest and other income (expense), net ($USD Thousands)$6,249 $5,653 $5,128 $4,422
Interest expense ($USD Thousands)$(321) $(868) $(877) $(834)
Net loss ($USD Thousands)$(41,109) $(55,854) $(57,763) $(49,732)
Net loss per share ($USD)$(0.69) $(0.92) $(0.95) $(0.82)
Weighted avg shares (shares)59,904,481 60,382,796 60,730,935 60,854,322

Segment breakdown: Not applicable; company reports no revenue segments .

KPIs

KPIQ2 2024Q3 2024Q4 2024
Cash, cash equivalents and short-term investments ($USD Millions)$438.1 $406.0 $357.2 (includes restricted cash)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
BEACON-IPF Phase 2b/3 statusQ4 2024On track for full enrollment in Q1 2025; data mid-2026 Discontinued after DSMB and outside expert panel recommendation; early FVC efficacy observed; full data to be analyzed to determine next steps Lowered/Terminated
PLN-101095 (solid tumors) interim data timingQ4 2024Preliminary data expected late 2024/early 2025; dosing third cohort Interim data from first three cohorts expected Q1 2025; dosing fourth of five cohorts Maintained/Clarified
PLN-101325 (muscular dystrophies) statusQ4 2024Generating additional evidence; potential expansion before Phase 1 Phase 1-ready; CTA open in Australia Raised/Advanced
Cash runwayQ4 2024“Sufficient to fund operations for the next 12 months and beyond” Forward-looking statements indicate cash runway into second half of 2026 (including Oxford Loan Agreement access) Improved/Extended

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was available in the document set reviewed; themes reflect press releases/8-K disclosures .

TopicPrevious Mentions (Q2 & Q3)Current Period (Q4 2024)Trend
BEACON-IPF trial executionEnrollment “on track” for Q1 2025 completion; data mid-2026 Discontinued by DSMB/outside expert panel due to AE imbalance; early FVC efficacy observed Negative shift; program reset
PSC (INTEGRIS-PSC)Positive long-term 320 mg data; well tolerated; antifibrotic and anti-cholestatic activity; FDA supportive of Phase 2b with non-invasive endpoints No new PSC data in Q4 release; prior positive AASLD presentation in Nov 2024 reinforced signals Neutral pending next steps
Oncology (PLN-101095)Dosing third cohort; preliminary data early 2025 Dosing fourth cohort; interim data Q1 2025 Progressing
Neuromuscular (PLN-101325)Evaluating potential expansion; pre-Phase 1 Phase 1-ready; CTA open in Australia Advancing
Liquidity/runway$438.1M (Q2), $406.0M (Q3) cash and ST investments $357.2M (Q4) cash, equivalents, restricted cash and ST investments; runway 12+ months, forward-looking to H2 2026 Lower cash; extended runway guidance
Regulatory/legal/processRoutine forward-looking risk disclosures Multiple investor alerts; adoption of stockholder rights plan; program discontinuation disclosures (press releases around Mar 2025) Heightened legal/corporate defense posture

Management Commentary

  • “A highlight to this quarter’s progress was the continued strong execution of our BEACON-IPF Phase 2b/3 trial which is enrolling well and on track to complete enrollment in the first quarter of 2025.” — Bernard Coulie, CEO (Q3 2024) .
  • “The recent bexotegrast data releases in IPF and PSC have exceeded our expectations…illustrate bexotegrast’s potential to provide clinical benefit to the many IPF patients in need.” — Bernard Coulie, CEO (Q2 2024) .
  • Q4 update emphasized the DSMB/outside expert panel-driven discontinuation and noted early efficacy evidence on FVC, with intent to analyze complete BEACON-IPF data and determine next steps for bexotegrast .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available; no Q&A themes could be assessed from primary source documents [List search results].

Estimates Context

  • Wall Street consensus estimates (EPS, revenue) for Q4 2024 were unavailable via S&P Global at time of writing; therefore, comparisons vs estimates cannot be provided. Values would be retrieved from S&P Global if accessible.

Key Takeaways for Investors

  • The discontinuation of BEACON-IPF on safety grounds is a material setback for the lead asset, although early FVC efficacy signals suggest biological activity that could inform future development strategy after full data analysis .
  • Financial profile remains pre-revenue with R&D intensity; Q4 net loss widened YoY to $49.7M while EPS improved sequentially to $(0.82) as R&D spend declined vs Q3 .
  • Liquidity of $357.2M at year-end provides a runway the company describes as 12+ months and, per forward-looking statements, into H2 2026, which supports continued development in oncology and neuromuscular programs post-BEACON reset .
  • Oncology program PLN-101095 is advancing (fourth cohort dosing) with interim data expected in Q1 2025, offering a near-term data catalyst outside IPF .
  • PLN-101325 has moved to Phase 1-ready status with CTA in Australia, adding optionality in neuromuscular indications .
  • PSC program showed encouraging signals in prior period presentations, but next clinical steps remain to be clarified in light of portfolio reprioritization post-BEACON .
  • With estimates unavailable, near-term stock narrative will be driven by clarity on bexotegrast’s path forward (post-data analysis), timing and quality of oncology interim data, and confirmation of runway guidance versus cash burn trajectory .