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BH

BIO-PATH HOLDINGS, INC. (BPTH)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 focused on strategic expansion: BPTH initiated its first non-oncology program (BP1001-A for obesity/metabolic disease) and highlighted rapid progress in oncology (BP1002 third dosing cohort in venetoclax‑resistant AML completed enrollment faster than projected) .
  • Operating profile improved YoY: net loss narrowed to $2.1M (vs. $3.2M in Q3’23) and loss/share improved to $0.70 (vs. $6.36), driven in part by lower R&D spend; G&A rose on legal and comp .
  • Liquidity was tight at quarter-end ($0.6M cash), but the company raised ~$4.0M in October via a private placement to extend runway .
  • Near-term stock catalysts: obesity program preclinical readouts, BP1001‑A solid tumor dose-escalation updates, and BP1002 higher-dose cohort/Phase Ib combination start; management’s tone was confident about platform expansion and clinical momentum .

What Went Well and What Went Wrong

What Went Well

  • Platform expansion beyond oncology: management launched BP1001‑A obesity program, citing rationale to improve insulin sensitivity by downregulating Grb2; preclinical work to confirm mechanism commenced in Q4 .
    • “This marks the first application of our DNAbilize platform for development of a noncancer application, which highlights the broad therapeutic potential of this technology.” — CEO Peter Nielsen .
  • Clinical execution: BP1002 AML Phase 1/1b third cohort enrollment completed “within six weeks,” ahead of projections, underscoring unmet need in venetoclax‑resistant patients .
  • Positive clinical signal in solid tumors: a patient in the BP1001‑A Phase 1/1b second dose cohort showed a 15% reduction in primary tumor after six cycles on monotherapy, with quality‑of‑life improvements noted .

What Went Wrong

  • Liquidity strain: cash was $0.6M at 9/30/24, necessitating subsequent financing (raised ~$4.0M in October) .
  • R&D spending down YoY, partly due to timing of AML BP1001 enrollment and lower manufacturing expenses—beneficial to loss profile but suggests cadence/timing variability in trial activity .
  • G&A increased YoY on legal fees and compensation, adding pressure to OpEx amid a limited cash balance .

Financial Results

Quarterly P&L and Cash (oldest → newest)

MetricQ1 2024Q2 2024Q3 2024
Net Loss ($USD Millions)$3.2 $1.9 $2.1
Diluted EPS (Loss) ($)$4.88 (loss per share) $1.16 (loss per share) $0.70 (loss per share)
R&D Expense ($USD Millions)$2.3 $1.9 $1.3
G&A Expense ($USD Millions)$1.4 $1.2 $1.3
Cash and Equivalents ($USD Millions)$0.2 (as of 3/31/24) $4.0 (as of 6/30/24) $0.6 (as of 9/30/24)

Q3 Year-over-Year (YoY) Comparison

MetricQ3 2023Q3 2024
Net Loss ($USD Millions)$3.2 $2.1
Diluted EPS (Loss) ($)$6.36 (loss per share) $0.70 (loss per share)
R&D Expense ($USD Millions)$2.3 $1.3
G&A Expense ($USD Millions)$1.0 $1.3

Notes: Company financials reflect a development-stage profile with no product revenues disclosed in these materials; bottom line driven by R&D and G&A .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Quantitative financial or operating guidanceN/ANone provided in prior updatesNone provided in Q3 materialsMaintained (no formal guidance)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2024)Current Period (Q3 2024)Trend
Obesity/metabolic expansionNo obesity program; focus on oncology pipeline and IP/financing in Q1; ASCO/EHA AML data in Q2 Initiated BP1001‑A program for obesity; preclinical studies underway; rationale: Grb2 downregulation to improve insulin sensitivity New strategic expansion beyond oncology
AML (BP1001)Ongoing Phase 2 combo with decitabine/venetoclax; interim signals better than current therapies; biomarker plan introduced in Q2 Continued advancement; no new interim efficacy disclosed in Q3 release/call Steady progress; awaiting next updates
Venetoclax‑resistant AML (BP1002)Completed second dose cohort; design and rationale to overcome BH3 resistance reiterated Third cohort (60 mg/m2) enrollment completed within six weeks; Phase Ib combo with decitabine expected after monotherapy cohorts Accelerating enrollment; approaching combo phase
Solid tumors (BP1001‑A)Dose escalation ongoing; data readout targeted later in 2024 Second cohort patient showed 15% tumor reduction on monotherapy; Phase 1b to test with paclitaxel and gemcitabine combos after monotherapy dose levels Early signal; moving toward combinations
STAT3 (BP1003)IND‑enabling path clarified; detection methodology established; preclinical data supportive Biomedicines paper highlighted broad anti-tumor effects; IND filing expected Preparing for first‑in‑human
Capital & liquidityQ1: $3.5M raised; Q2: $4.0M financing announced Q3 cash $0.6M; October private placement ~$4.0M closed Tight at quarter‑end but bolstered in October

Management Commentary

  • Strategic expansion: “Last month, we announced the initiation of our clinical development program for BP‑1001‑A as a treatment for obesity and related metabolic diseases. This marks the first application of our DNAbilize platform for development of a noncancer application...” — Peter Nielsen, CEO .
  • BP1002 rationale: “BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment.” — Peter Nielsen .
  • Pipeline cadence: “Enrollment was completed within 6 weeks, faster than projected, which underscores the continued need for new treatment options…” — Peter Nielsen (BP1002 AML) .
  • Operational tone: “Collectively, the progress we are making across our pipeline is setting the stage for a strong finish to the year…” — Peter Nielsen .

Q&A Highlights

  • The published transcript captured prepared remarks and the handoff to Q&A; specific analyst Q&A content was not available in the accessible transcript excerpts. Management reiterated readiness to take questions following prepared remarks .

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 2024 EPS and revenue was not retrievable in this session; the company’s releases/call did not cite external consensus, and no comparison to estimates was provided in the materials reviewed . Accordingly, beat/miss versus consensus cannot be assessed.

Key Takeaways for Investors

  • BPTH is broadening its addressable market with an obesity/metabolic program (BP1001‑A) while maintaining oncology momentum—an incremental strategic upside lever beyond hematologic and solid tumor indications .
  • Early clinical signal in solid tumors (15% tumor reduction in a heavily pretreated patient on BP1001‑A monotherapy) and rapid AML BP1002 cohort enrollment support continued clinical catalysts into the next cohorts/Phase 1b combinations .
  • Operating loss improved YoY on lower R&D (manufacturing and timing), but G&A pressure persists; careful expense control remains important given the development stage .
  • Liquidity requires active management: quarter‑end cash was $0.6M; October’s ~$4.0M raise extends runway but additional capital will likely be needed to fund multiple programs and combos .
  • Upcoming milestones to watch: BP1001‑A dose‑escalation updates and Phase 1b combo initiations; BP1002 transition to combo with decitabine; BP1003 IND progress; preclinical obesity program data flow .
  • Narrative shift: management’s confidence around platform extensibility (oncology → metabolic disease) could expand investor interest set if preclinical obesity data are supportive .

Additional Relevant Press Releases (Q3 timeframe and subsequent near-term)

  • Biomedicines publication showcasing BP1003 anti‑tumor potential across solid tumors (Sept 16) .
  • Initiation of BP1001‑A obesity program and BP1002 third cohort completion (Oct 8) .
  • $4.0M private placement pricing/closing (Oct 9–10) .
  • Q3 earnings call scheduling (Nov 8) .

Appendix: Source Financial Disclosures (Q3 2024)

  • Press release (Nov 15): net loss $2.1M; $0.70 loss/share; R&D $1.3M; G&A $1.3M; cash $0.6M (9/30); operating and financing cash flow YTD metrics .
  • 8‑K Item 2.02 & Exhibit 99.1: mirrors press release content and corporate/clinical updates .
  • Call remarks: reiterated financials and highlighted program progress and timelines .