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Aptose Biosciences Inc. (APTO)·Q3 2024 Earnings Summary

Executive Summary

  • Net loss narrowed to $6.95M (EPS $(0.37)) in Q3 2024, continuing sequential and year-over-year improvement driven by lower R&D and G&A spending .
  • Cash runway extended to January 2025 following a $10M loan facility from Hanmi and continued OpEx discipline; stockholders’ equity remained negative and Nasdaq compliance issues persist, with a hearing scheduled Nov 21, 2024 .
  • Triplet frontline AML program (tuspetinib + venetoclax + azacitidine) targeted to initiate dosing in Q4 2024; ASH 2024 update to include CR/safety from the TUS+VEN doublet and dosing accrual for the triplet .
  • No revenue reported (development-stage); estimate benchmarks unavailable via S&P Global for Q3 2024, limiting beat/miss analysis .
  • Potential stock catalysts: triplet study initiation and ASH 2024 data flow; risks include financing needs and Nasdaq listing compliance .

What Went Well and What Went Wrong

  • What Went Well

    • “Tuspetinib…with its breadth of activity and unique safety profile, is a potential game-changer as part of a triplet therapy regimen,” positioning APTO for frontline AML triplet development .
    • Operating expenses fell to $6.97M (from $11.68M YoY), with R&D down to $4.70M and G&A to $2.26M, reflecting reduced trial activity and tight cost control .
    • Secured a $10M Hanmi facility agreement and advanced co-development talks to accelerate tuspetinib; plan to initiate the triplet study in Q4 2024 with broad inclusion (FLT3-mutant and wild-type) .

  • What Went Wrong

    • Stockholders’ equity at $(9.13)M and working capital only $0.48M highlight balance sheet fragility; cash and investments were $7.96M at quarter-end .
    • Nasdaq compliance issues ongoing: equity deficiency (appeal/hearing Nov 21, 2024) and minimum bid price deficiency with a deadline to regain compliance by Jan 13, 2025 .
    • No commercial revenues; continued reliance on external financing and partnership support to fund clinical progress .

Financial Results

MetricQ3 2023Q1 2024Q2 2024Q3 2024
Operating Expenses ($USD Thousands)$11,681 $9,760 $7,345 $6,965
Research & Development ($USD Thousands)$8,256 $6,445 $4,413 $4,702
General & Administrative ($USD Thousands)$3,425 $3,315 $2,932 $2,263
Other Income ($USD Thousands)$234 $120 $93 $12
Net Loss ($USD Thousands)$(11,447) $(9,640) $(7,252) $(6,953)
Net Loss per Share ($)$(1.76) $(0.73) $(0.43) $(0.37)

Note: APTO reported no revenues as a development-stage company (e.g., Q1 2024) .

Balance sheet highlights:

Metric ($USD Thousands)Dec 31 2023Mar 31 2024Jun 30 2024Sep 30 2024
Cash, Cash Equivalents & ST Investments$9,252 $9,328 $8,330 $7,962
Working Capital$(3,375) $(318) $(2,552) $477
Total Assets$12,989 $12,796 $10,949 $10,929
Long-term Liabilities$621 $520 $414 $10,305
Stockholders’ Equity$(2,901) $137 $(2,176) $(9,134)

R&D program cost breakdown:

R&D Components ($USD Thousands)Q3 2023Q3 2024
Tuspetinib Program Costs$5,814 $4,067
Luxeptinib Program Costs$648 $(225)
APTO-253 Program Costs$2 $0
Personnel-related Expenses$1,523 $941
Stock-based Compensation$259 $(81)
Depreciation of Equipment$10 $0
Total R&D$8,256 $4,702

Shares outstanding (common):

DateShares Outstanding
May 14, 202416,309,393
Aug 8, 202418,109,393
Nov 8, 202419,521,183

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayFY 2024/2025Through August 2024 Through January 2025 Raised
Triplet Study – Initiation2H 2024 / Q4 2024Pilot dose initiation in 2H 2024 Initiate dosing of TUS+VEN+AZA in Q4 2024 Maintained/Timing Specified
Triplet Study – ASH 2024Dec 2024Early ND AML data at ASH 2024 Report CR/safety (doublet) and triplet dosing accrual at ASH 2024 Maintained
Triplet Study – EHA 2025Mid 2025CR/MRD dose selection; EHA 2025 Maturing data readout at EHA 2025 Maintained
Pivotal Program (Ph 2/3)2H 2025Planned initiation 2H 2025 Select TUS dose and prepare for Ph 2/3 pivotal program Maintained
Nasdaq – Equity Requirement2024Compliance plan submitted (May 17, 2024) Hearing scheduled Nov 21, 2024 Escalated to Hearing
Nasdaq – Minimum Bid Price2024/2025Deadline Jan 10, 2025 Deadline Jan 13, 2025; possible extension at Nasdaq’s discretion Maintained/Updated Date

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q1)Current Period (Q3)Trend
Frontline Triplet StrategyFDA allowed triplet at 40 mg; protocol ready; sites activating Triplet dosing to initiate in Q4; broad inclusion across FLT3 status Progressing to dosing
Safety/Mechanistic ProfileEmphasized TUS safety (no QTc/CPK elevation, no differentiation syndrome), mechanistic complementarity with VEN/HMA Reinforced unique safety profile as “potential game-changer” in triplet Consistently positive
Data Flow (EHA/ASH)EHA 2024 poster; ASH 2024 initial triplet data planned ASH 2024 CR/safety (doublet) and triplet accrual; EHA 2025 maturing readout On track
Financing/HanmiPrior private placement; regained compliance on Nasdaq 5635(d) $10M Hanmi facility; co-dev talks ongoing Strengthened liquidity
Nasdaq ComplianceEquity deficiency plan submitted; minimum bid price deficiency window Equity hearing set; bid price deadline Jan 13, 2025 Heightened risk management

Management Commentary

  • “Tuspetinib…is a potential game-changer as part of a triplet therapy regimen and we continue to advance its development.” — William G. Rice, Ph.D., Chairman, President & CEO .
  • “Tuspetinib is a natural third agent…has an excellent safety profile…enhances antileukemic activity when combined with venetoclax and HMAs…targets known venetoclax resistance mechanisms.” — Prepared remarks context on TUS mechanistic fit .
  • “We expect to report clinical data with the TUS-VEN-HMA triplet…during the second half of this year.” — Prepared remarks on timeline (Q1 call) .

Q&A Highlights

  • Benchmark for pilot triplet success: move toward higher response rates vs VEN+HMA (targeting ~75% CR/CRi would be encouraging), with overall survival the ultimate metric longer-term .
  • Study design aligned to maintain standard-of-care dosing (VEN/HMA) in the treatment arm; aim to demonstrate robust safety without dose reductions typical of other kinase inhibitor triplets .
  • Triplet protocol developed with leading PIs (e.g., Dr. Naval Daver) and based on VEN-AZA label experience; not primarily a result of back-and-forth with FDA beyond amendment submission .

Estimates Context

  • Wall Street consensus EPS and revenue estimates via S&P Global for Q3 2024 were unavailable (data mapping limitations); therefore, results cannot be benchmarked against consensus this quarter.

Key Takeaways for Investors

  • Cash runway extended to January 2025; however, negative equity and upcoming Nasdaq hearing underscore continuing financing and listing risk—watch for resolution and potential capital actions .
  • $10M Hanmi facility and co-development discussions are supportive of accelerating triplet development; collaboration completion targeted around year-end 2024 .
  • Triplet study initiation in Q4 2024 and ASH 2024 updates are near-term catalysts; data quality and safety profile relative to other triplets will drive narrative and valuation .
  • Operating expenses continue to decline (OpEx $6.97M; R&D $4.70M), signaling disciplined spend and focus on tuspetinib triplet execution .
  • No revenues and reliance on external funding/partner support persist; monitor clinical progress, capital inflows, and updated guidance for 2025 .
  • Nasdaq minimum bid price window runs to Jan 13, 2025; failure to regain compliance risks delisting—stock volatility likely around listing developments .
  • If early triplet data at ASH/EHA validate safety and broad efficacy (including FLT3 wild-type), APTO could pursue a randomized registrational path; funding runway and partner support will be critical .