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BH

BIO-PATH HOLDINGS, INC. (BPTH)·Q4 2024 Earnings Summary

Executive Summary

  • Bio-Path reported FY 2024 results alongside Q4 period-end updates: net loss improved to $9.9M with EPS of $4.12 versus FY 2023 loss of $16.1M and EPS of $33.63, driven by lower R&D and a non-cash warrant liability gain .
  • The company expanded DNAbilize® beyond oncology with BP1001-A obesity program; preclinical data showed enhanced insulin sensitivity and restored insulin signaling, positioning obesity/metabolic as a new catalyst alongside AML and solid tumor programs .
  • Liquidity remained constrained: cash was $1.2M at year-end; financing activity provided $10.7M in 2024 and an additional $4.0M gross in October 2024, but runway remains a focus for investors .
  • No Q4 2024 earnings call transcript was available; consensus estimates via S&P Global were unavailable for Q4/FY 2024, limiting beat/miss analysis. Management commentary draws from FY press release and prior Q3/Q2 calls .
  • Near-term stock reaction catalysts center on: obesity/metabolic data flow, AML/solid tumor dose-escalation milestones, and financing/partnership updates; IP portfolio expansion adds strategic optionality .

What Went Well and What Went Wrong

What Went Well

  • R&D efficiency: FY 2024 R&D expense decreased to $7.3M vs $11.6M in FY 2023, cutting the annual net loss by ~39% YoY .
  • Pipeline expansion: Initiated BP1001-A in obesity/metabolic with positive preclinical results that enhanced insulin sensitivity and restored insulin signaling in cell models, broadening platform scope .
  • IP strengthening: Notices of allowance/grants in the U.S. and New Zealand contributed to seven issued U.S. patents and 61 foreign, covering 26 countries, fortifying DNAbilize® defensibility .
    • “We are merely touching the tip of the iceberg in terms of realizing the potential of our DNAbilize® platform…” — CEO Peter Nielsen .

What Went Wrong

  • Liquidity tightness: Cash was $0.6M at 9/30/24 and $1.2M at 12/31/24; despite $4.0M gross raised in October, the business remains dependent on external financing for operations .
  • Clinical prioritization challenges: Discontinued the BP1002 Phase 1 study in lymphoma/CLL due to enrollment difficulties in niche indications; resources reallocated toward metabolic program .
  • Limited investor visibility: No Q4 call transcript; S&P Global consensus estimates unavailable; reduces comparability and near-term beat/miss framing for institutional investors .

Financial Results

Quarterly Operating Metrics

MetricQ2 2024Q3 2024Q4 2024
Net Loss ($USD Millions)$1.9 $2.1 N/A (not disclosed)
EPS ($USD)$1.16 $0.70 N/A (not disclosed)
R&D Expense ($USD Millions)$1.9 $1.3 N/A (not disclosed)
G&A Expense ($USD Millions)$1.2 $1.3 N/A (not disclosed)
Cash & Equivalents (period end) ($USD Millions)$4.0 $0.6 $1.2 (FY year-end)

Full-Year YoY Comparison

MetricFY 2023FY 2024
Net Loss ($USD Millions)$16.1 $9.9
EPS ($USD)$33.63 $4.12
R&D Expense ($USD Millions)$11.6 $7.3
G&A Expense ($USD Millions)$4.2 $4.7
Change in FV of Warrant Liability ($USD Millions)$(0.3) $2.1
Cash & Equivalents (period end) ($USD Millions)$1.1 $1.2

Notes:

  • The company does not report revenue; results focus on operating expenses and losses. Q4-specific P&L line items were not disclosed in filings/press releases; FY 2024 was reported .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial guidance (Revenue, EPS, margins, OpEx)FY/Q4 2024NoneNoneMaintained (no guidance provided)
Clinical milestones2024–2025Dose-escalation and IND-enabling plans referencedContinued dose-escalation, IND-enabling/preclinical, animal studies initiated; anticipate Phase 1 obesity first-in-human in 2025Qualitative updates only

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Obesity/metabolic (BP1001-A)Not yet initiated; platform described; oncology focus Program initiated; rationale to downregulate Grb2 to improve insulin sensitivity Preclinical data: enhanced insulin sensitivity; restored insulin signaling; animal studies underway Expanding beyond oncology; accelerating preclinical validation
AML (prexigebersen/BP1001 Phase 2)Interim data at ASCO/EHA; biomarker package development Continued advancement; Stage 2 structure and endpoints reaffirmed Continued development in FY results overview Ongoing; building evidence and clinical execution
BP1002 (BCL-2; AML)Completed second dosing cohort; plan for Phase Ib combination with decitabine Enrollment swift for third cohort (60 mg/m2) Reallocation away from lymphoma/CLL due to enrollment; AML program update continues Focus sharpened on AML; deprioritized niche indications
BP1003 (STAT3; IND path)Preclinical efficacy; progressing IND-enabling (oligo detection in plasma) Publication in Biomedicines; continued IND preparation Patent portfolio enlarged; continued platform/IP progress Continuing toward IND; broader platform/IP moat
Financing/liquidity$4.0M June placement; cash $4.0M at Q2 $4.0M Oct placement; cash $0.6M at Q3 FY cash $1.2M; $10.7M financing cash flow in 2024 Dependent on financing; runway watchpoint

Management Commentary

  • “We are merely touching the tip of the iceberg…to change the treatment paradigm in both obesity and oncology.” — Peter H. Nielsen, CEO (FY release) .
  • “BP1001-A…suppresses the adaptor protein Grb2…has the potential to treat insulin resistance…we expect downregulating GRB2 expression…will enhance insulin sensitivity.” (Q3 call) .
  • “We…were delighted with the swift enrollment of the third cohort in our Phase 1/1b clinical trial of BP1002 in venetoclax-resistant AML patients, which was ahead of our projected timelines.” (Q3 release) .
  • “We look forward to completing IND-enabling testing in the fourth quarter of 2024 and to advancing this important metabolic program in 2025.” (Dec 11 press release) .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available; Q3 and Q2 materials primarily include prepared remarks without detailed Q&A excerpts .
  • Clarifications on dose-escalation designs and combinations (decitabine, paclitaxel, gemcitabine) were conveyed in prepared remarks and press releases, indicating next steps and endpoints rather than numeric guidance .

Estimates Context

  • S&P Global consensus estimates for Q4 2024 and FY 2024 were unavailable for BPTH; no analyst count/targets were returned, so beat/miss analysis versus Street cannot be performed. Values retrieved from S&P Global.*
  • Investors should anchor expectations on operating expense trends, financing cadence, and clinical milestone timing given the absence of revenue and consensus coverage .

Key Takeaways for Investors

  • R&D discipline cut FY 2024 net loss materially; non-cash warrant liability gain aided EPS optics, but core cash burn remains significant .
  • Liquidity is tight despite October financing; monitor additional capital raises and potential strategic partnerships to sustain clinical timelines .
  • Obesity/metabolic program is an emerging catalyst with positive preclinical signals on insulin sensitivity; animal studies underway and first-in-human targeted for 2025 .
  • Oncology pipeline continues to advance: AML (BP1001) with prior ASCO/EHA visibility; BP1002 AML dose-escalation progressed rapidly; BP1003 IND path strengthened by preclinical data and IP .
  • No financial guidance and no Q4 call reduce near-term visibility; trading likely to react to discrete data releases and financing events rather than earnings prints .
  • With consensus estimates unavailable, positioning relies on milestone execution and cash management; any delay in clinical progress or financing could pressure sentiment .
  • IP consolidation (new U.S./NZ patents) supports long-term platform value across oncology and metabolic indications .

Appendix: Prior Quarters’ Summary (for trend analysis)

  • Q2 2024: Net loss $1.9M; EPS $1.16; R&D $1.9M; G&A $1.2M; cash $4.0M; $4.0M financing closed in June; ASCO/EHA interim AML data presented .
  • Q3 2024: Net loss $2.1M; EPS $0.70; R&D $1.3M; G&A $1.3M; cash $0.6M; obesity program initiated; BP1002 AML cohort enrolled faster than projected; $4.0M October financing .

Notes:

  • FY 2024 press release was furnished via an 8-K Item 2.02, with Exhibit 99.1 containing detailed results .
  • No Q4 2024 earnings call transcript was available in the document set; qualitative analysis leverages FY release and prior quarter calls .