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BH

BIO-PATH HOLDINGS, INC. (BPTH)·Q1 2024 Earnings Summary

Executive Summary

  • Clinical-stage biotech quarter with continued pipeline execution: net loss narrowed YoY on lower manufacturing spend; R&D progress across BP1001 (prexigebersen), BP1002 (Bcl‑2), and BP1003 (STAT3) sustained the narrative despite limited cash at quarter-end .
  • No top-line revenue and no formal financial guidance; operating loss improved YoY, aided by lower manufacturing and offset by modestly higher G&A; EPS was a loss of $4.88 vs $13.25 YoY; prior-quarter quarterly EPS not furnished (company furnished FY 2023 in March) .
  • Balance sheet bolstered post-quarter by $3.5M gross proceeds (ATM + registered direct in April) and a subsequent $4.0M private placement closed June 5, improving near-term liquidity runway and execution capacity for trials .
  • Estimate context unavailable: S&P Global consensus for Q1 2024 EPS/revenue was not retrievable at time of analysis due to access constraints; beats/misses cannot be assessed objectively at this time.

What Went Well and What Went Wrong

What Went Well

  • Clinical milestones and IP expansion: “The multiple milestones achieved throughout the first quarter and in recent weeks are creating momentum… We made meaningful progress across all areas of the business” as management highlighted new patents in Mexico, Australia, and Japan; portfolio now five U.S. and 54 foreign issued patents across 21 countries .
  • BP1002 dose-escalation advancement in AML: completion of second monotherapy dose cohort (20 and 40 mg/m²) with no DLTs; FDA data review expected before advancing to 60 mg/m²; Phase 1b to assess combo with decitabine in R/R AML .
  • Operating discipline: Net loss narrowed YoY to $3.2M (from $5.3M); R&D down to $2.3M (from $4.0M) primarily on lower manufacturing expenses; operating cash burn improved to $1.0M (from $3.7M) .

What Went Wrong

  • Liquidity tight at quarter-end: cash of $0.2M on March 31, 2024; continued reliance on external capital, albeit mitigated by April raises ($3.5M) and June private placement ($4.0M) .
  • Limited visibility on near-term catalysts with no quantitative guidance; timelines remain framed as “expects” (e.g., BP1001‑A readout “potentially later this year,” BP1003 IND readiness) .
  • No revenue base and thus no operating leverage or margin profile; investors must underwrite clinical execution and financing risk absent commercial cash flows .

Financial Results

Note: The company is pre-revenue and did not present revenue in the Q1 2024 or Q3 2023 earnings releases; margins are not meaningful in absence of revenue .

MetricQ1 2023 (YoY)Q3 2023Q1 2024
Net Loss ($USD Millions)$(5.3)$ $(3.2)$ $(3.2)$
Diluted EPS ($USD)$(13.25)$ $(0.32)$ $(4.88)$
R&D Expense ($USD Millions)$4.0$ $2.3$ $2.3$
G&A Expense ($USD Millions)$1.3$ $1.0$ $1.4$
Operating Cash Used ($USD Millions)$(3.7)$ N/A$(1.0)$

Liquidity and subsequent financing:

MetricSep 30, 2023Dec 31, 2023Mar 31, 2024Post-quarter Events
Cash & Equivalents ($USD Millions)$2.4$ $1.1$ $0.2$ $3.5M gross raised in April (ATM + registered direct) ; $4.0M private placement closed June 5

Estimates vs. Actuals:

  • Wall Street consensus (S&P Global) for Q1 2024 EPS and revenue was unavailable at time of analysis due to access constraints; beat/miss cannot be determined.

Segments/KPIs:

  • No revenue segments. Key operating KPIs are clinical milestones noted below.

Guidance Changes

No quantitative financial guidance was provided. Management reiterated qualitative clinical expectations; we map them below.

Metric/ProgramPeriodPrevious Guidance/CommentaryCurrent Guidance/CommentaryChange
Prexigebersen (BP1001) in AML (Phase 2)2024Positive interim Stage 2 data; plan to pursue FDA expedited programs (Fast Track) Continues to highlight compelling interim data; “plan to pursue… Fast Track designation” for AML patients unable to receive intensive chemo Maintained
BP1002 in AML (Phase 1/1b)2024First dose cohort (20 mg/m²) completed; no DLT; planning escalation Second cohort (40 mg/m²) completed; brief FDA data review; anticipate escalation to 60 mg/m²; 1b combo with decitabine thereafter Progressed
BP1002 in Lymphoma/CLL (Phase 1)2024First cohort completed; enrollment open for 40 mg/m² Enrollment open for second cohort (40 mg/m²) with safety/tolerability as primary objective Maintained/Executing
BP1001‑A (solid tumors)2024Dose 2 enrolling at 90 mg/m²; potential 2024 readout “Look forward to cohort completion and data readout… potentially later this year” Maintained
BP1003 (STAT3) IND prep2024Identified plasma oligo detection method enabling final safety testing to complete IND package “Identified a method… to complete final safety testing needed to finalize an IND” and “excited to launch first‑in‑human” after IND Maintained

Earnings Call Themes & Trends

TopicQ3 2023 (11/15/23)Q4 2023 (3/8/24)Q1 2024 (5/15/24)Trend
AML efficacy (BP1001)Positive interim Stage 2 data exceeding DV outcomes; KOL enthusiasm Reinforced compelling efficacy; plan for FDA expedited programs Reiterates compelling data and Fast Track pursuit Consistently positive, moving toward expedited pathways
BP1002 AML dose escalationFirst cohort completed; planning escalation First cohort complete; enrolling next Second cohort complete; FDA review before 60 mg/m² Advancing dose levels
BP1002 Lymphoma/CLLFirst cohort completed Enrollment open for 40 mg/m² Enrollment open; safety focus Steady execution
BP1001‑A in solid tumorsDose 2 at 90 mg/m²; potential 2024 data Potential 2024 readout reiterated Maintained expectations
BP1003 INDIND-enabling method for oligo detection identified Same; IND finalization path reiterated IND on track pending testing
IP portfolioNew patents in MX/AU/JP; total 5 U.S./54 foreign in 21 countries Strengthened IP globally
Balance sheet/capitalCash $2.4M (9/30/23) Cash $1.1M (12/31/23) Cash $0.2M (3/31/24); raised $3.5M Apr; $4.0M Jun private placement Liquidity reliant on raises; runway extended post-quarter

Management Commentary

  • “The multiple milestones achieved throughout the first quarter and in recent weeks are creating momentum to help advance our goal to deliver a better path for cancer patients… expanding our global patent portfolio and strengthening the balance sheet” — Peter Nielsen, CEO .
  • “We currently plan to pursue… Fast Track designation for… AML treatment in patients who are unable to receive intensive chemotherapy” .
  • On BP1002 AML: “Completion of the second dose cohort… [20 and 40 mg/m²]; approved treatment cycle is 2 doses per week over 4 weeks… Phase I/Ib portion… will assess… in combination with decitabine” .
  • On financials: “Net loss of $3.2 million or $4.88 per share… R&D decreased to $2.3 million… G&A increased to $1.4 million… cash of $0.2 million… subsequent $3.5 million gross proceeds” — Anthony Price, CFO .

Q&A Highlights

  • The Q1 2024 call transcript includes prepared remarks and opened the line for questions, but no Q&A exchange was transcribed in the provided document .
  • For investor context, prior-quarter (Q4 2023) Q&A covered: Fast Track opportunity/target population in AML ; anticipated BP1002 combination dosing ranges post‑monotherapy escalation (60–90 mg/m²) ; BP1001‑A dose cohorts and 2024 readout potential; BP1003 IND timeline readiness .

Estimates Context

  • S&P Global consensus estimates for Q1 2024 EPS and revenue were unavailable at time of analysis due to access constraints, so we cannot quantify beats/misses versus Street expectations. We will update when access allows.

Key Takeaways for Investors

  • Clinical execution remains on track with tangible progress in BP1002 dose escalation (AML and Lymphoma/CLL), maintenance of BP1001‑A 2024 readout expectations, and BP1003 IND readiness, supporting the platform thesis .
  • Balance sheet was extremely constrained at quarter-end ($0.2M cash), but subsequent raises ($3.5M in April; $4.0M private placement closed June 5) materially improve near-term runway; financing remains an ongoing dependency .
  • Operating spend discipline evident: R&D down YoY on lower manufacturing outlays; cash burn improved YoY; however, G&A ticked up on legal fees .
  • Potential regulatory catalyst: management intends to pursue Fast Track for BP1001 in AML patients unsuitable for intensive chemo—an approval of expedited status would be a medium-term derisking event .
  • IP moat expanding with additional international patents, which can support partnering and valuation arguments as assets mature .
  • Absent revenue and formal guidance, the stock will trade on clinical data cadence, regulatory progress, and financing visibility; monitoring the transition to higher BP1002 dose cohorts and BP1001‑A readouts is key for near-term sentiment .
  • Street estimate comparisons are unavailable; in the near term, stock moves likely tied to clinical headlines and capital markets activity rather than quarterly P&L.

Appendix: Additional Data and Press Releases

  • June 14, 2024: EHA poster reiterated compelling efficacy in both newly diagnosed and R/R AML cohorts for prexigebersen + decitabine + venetoclax; tolerability consistent with expectations .
  • June 5, 2024: Closed $4.0M private placement with five‑year Series A and 24‑month Series B warrants (exercise price $2.00) .
  • June 4, 2024: Announced $4.0M private placement terms ahead of close .

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