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Aptose Biosciences Inc. (APTO)·Q1 2024 Earnings Summary

Executive Summary

  • Aptose reported Q1 2024 with no revenue, net loss of $9.64M ($0.73 per share), and operating expenses of $9.76M as it pivots tuspetinib to a frontline triplet (TUS+VEN+HMA) in newly diagnosed AML; cash and investments were $9.33M with runway guided “through August 2024” .
  • The Q1 call focused on strategy: protocol for the triplet was submitted to FDA in Q1 and sites are being activated; first dosing targeted for early Q2/Q3 timing with initial triplet data expected by year-end (ASH 2024) .
  • Management emphasized tuspetinib’s safety and mechanistic complementarity with venetoclax to address VEN resistance and broaden activity across AML genotypes (including FLT3 wildtype, TP53 and RAS mutations) .
  • S&P Global consensus estimates for APTO were unavailable via our data connector; thus no beat/miss versus consensus can be determined for Q1 2024 (S&P Global mapping not available) [SpgiEstimatesError].

What Went Well and What Went Wrong

What Went Well

  • Triplet strategy execution momentum: FDA submission for the TUS+VEN+HMA frontline pilot protocol in Q1; sites now being activated; first enrollment expected early next quarter, with initial efficacy/safety readouts targeted for ASH 2024 .
  • Differentiated safety/biology: Management reiterated no drug-related QTc prolongation/CPK elevation, no differentiation syndrome, and no drug-related myelosuppression during remission; broad activity across FLT3-mut/wt, TP53 and RAS mutations, and prior VEN/FLT3i/HSCT settings supports triplet move-up .
  • Clear near-term catalysts: EHA 2024 poster (single-agent/doublet safety/efficacy), triplet first-patient-in summer 2024, and ASH 2024 early CR/MRD/safety update; milestones laid out through EHA 2025 and potential Ph2/3 start in 2H 2025 .

What Went Wrong

  • Limited cash runway: Cash/short-term investments of $9.33M with guidance to fund operations only through August 2024; company also disclosed Nasdaq stockholders’ equity deficiency on April 2, 2024 (since turned positive at March 31) and is pursuing compliance plans .
  • No revenue and ongoing losses: Q1 had no revenue and a net loss of $9.64M; R&D was $6.45M and G&A $3.32M as the company invests behind TUS clinical programs .
  • Estimate visibility: S&P Global consensus not available via our feed, limiting external benchmarking and “beat/miss” framing for traders this quarter (note: micro-cap biotech coverage constraints) [SpgiEstimatesError].

Financial Results

Note: Q4 2023 discrete values are calculated from FY 2023 minus 9M 2023 where needed; all source citations provided.

Metric (USD)Q3 2023Q4 2023Q1 2024
Revenue ($M)$0.00 (pre-revenue) $0.00 (FY 2023 had no revenue) $0.00 (no revenues in Q1)
Net Loss ($M)$(11.45) $(11.96) (FY $51.21 − 9M $39.25) $(9.64)
Diluted EPS ($)$(1.76) N/A (not disclosed quarterly)$(0.73)
R&D Expense ($M)$8.26 $5.62 (FY $33.27 − 9M $27.65) $6.45
G&A Expense ($M)$3.43 $3.01 (FY $15.59 − 9M $12.58) $3.32
Operating Expenses ($M)$11.68 $8.64 (FY (R&D+G&A) $48.86 − 9M $40.23) $9.76
Other Income, net ($M)$0.23 $0.17 (FY $1.15 − 9M $0.98) $0.12
Cash & Investments ($M)$17.72 (9/30/23) $9.25 (12/31/23) $9.33 (3/31/24)
Stockholders’ Equity ($M)$7.78 (9/30/23) $(2.90) (12/31/23) $0.14 (3/31/24)

Estimate comparison (consensus unavailable):

  • S&P Global consensus estimates for Q1 2024 EPS and revenue were unavailable via our data connector; therefore, we cannot benchmark actuals vs. Street this quarter (values would typically be sourced from S&P Global). Values retrieved from S&P Global were unavailable due to mapping. [SpgiEstimatesError]

Segment breakdown / KPIs:

  • No revenue segments yet (clinical-stage). Key operating KPIs emphasized: R&D spend, cash runway, and clinical milestones (EHA/ASH/triplet initiation) .

Guidance Changes

Aptose did not provide quantitative financial guidance; the company outlined clinical/milestone timelines.

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Triplet pilot initiation (TUS+VEN+HMA)1L AML1H/“Summer 2024” “Summer 2024”/early next quarter Maintained
Initial triplet data (CR/MRD/safety)ASH 2024ASH 2024 ASH 2024 Maintained
Triplet pilot completion & dose selectionEHA 2025EHA 2025 EHA 2025 Maintained
Pivotal Ph2/3 start2H 20252H 2025 2H 2025 Maintained
Cash runwayThrough ~Aug 2024Through Aug 2024 Through Aug 2024 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023 and Q4 2023)Current Period (Q1 2024)Trend
Triplet strategy (TUS+VEN+HMA) move to 1L AMLAnnounced plan to initiate 1L triplet pilot; VEN-resistance rationale highlighted Protocol submitted in Q1; sites activating; first patient expected early next quarter; data targeted for ASH 2024 Accelerating execution
Safety profile and breadth of activityFavorable safety; activity in FLT3-mut/wt; VEN-resistant contexts Reinforced lack of typical tox (QTc, CPK, differentiation syndrome, drug-related myelosuppression in remission); mechanistic complementarity with VEN Consistently positive
Regulatory interactionsInitiation plans discussed; no specific submission updates Protocol submitted to FDA in Q1; triplet protocol now open Progressing
R&D focus / spendHeavy TUS investment; LUX G3 bioavailability achieved R&D lower YoY as APTIVATE enrollment completed; focus on triplet pilot Spend optimized
Capital/ListingCash runway through March 2024 (then extended via financings) ; financings in Jan 2024 Runway through Aug 2024; regained compliance on 5635(d); equity deficiency letter addressed with plan Stabilizing but tight

Management Commentary

  • “Our solution is the addition of TUS to VEN-HMA to increase response rates, prolong survival, safely improve quality of life, treat a broad spectrum of AML genetic subpopulations, and prevent ND AML patients from becoming resistant to VEN… we look forward to sharing initial TUS+VEN+HMA triplet data before year-end.” – William G. Rice, CEO .
  • “Tuspetinib… targets SYK, FLT3, mutated KIT, JAK1/2, and RSK2… avoids many typical toxicities… no drug-related myelosuppression during remission… blast reductions and responses were observed… including TP53 and RAS mutations.” .
  • “TUS+VEN show mechanistic complementarity… TUS inhibits FLT3, KIT, SYK, JAK/STAT, RSK2 and indirectly reduces MCL-1… may minimize drug resistance.” .
  • “The pilot study will treat ~20–36 older/unfit patients… ~50% with FLT3 mutations… dosing structured to maintain SOC backing and manage myelosuppression per VEN/HMA label.” – Rafael Bejar, CMO .
  • “Based on current operations, cash on hand plus our ATM will provide sufficient resources to fund planned operations… through August of 2024.” – Fletcher Payne, CFO .

Q&A Highlights

  • Triplet protocol design vs FDA interactions: Design driven by expert PI experience and the VEN/HMA label; protocol amendment submitted ~45–50 days prior, but design is not a direct result of back-and-forth with FDA .
  • Benchmarks for success: Expectation to improve response rates beyond ~66% CR/CRi seen in VIALE-A SOC; management suggested comfort at ~75%+ range over time, with robustness building as pilot completes; emphasis on maintaining VEN/HMA dosing to allow clean, placebo-controlled registrational design .

Estimates Context

  • S&P Global consensus estimates for Q1 2024 revenue and EPS were unavailable via our connector due to a mapping limitation, so we cannot assess beat/miss vs. Street this quarter. Values retrieved from S&P Global were unavailable due to mapping. [SpgiEstimatesError]
  • Given micro-cap status and clinical-stage profile with no revenues, Street coverage may be sparse; we would expect updates to focus on cash runway and clinical milestone timing .

Key Takeaways for Investors

  • The story is now a clinical-catalyst setup: triplet protocol submitted and opening at sites, with initial readout targeted for ASH 2024 and multiple milestones through EHA 2025; these events are likely the primary stock catalysts near term .
  • Differentiated safety/mechanistic rationale vs other triplet approaches may enable maintaining full SOC dosing, which is critical for registrational design and could be a competitive advantage if sustained in real-world data .
  • Breadth beyond FLT3-mut (into FLT3-wt, TP53, RAS) remains a core part of the thesis; confirmation in VEN-naïve frontline patients will be pivotal for the market opportunity .
  • Balance sheet remains tight: cash/short-term investments of $9.33M and runway to August 2024; further financing/partnership optionality or data-driven re-rating likely required to secure next phases .
  • Listing status: regained compliance with Nasdaq Rule 5635(d); stockholders’ equity turned positive at March 31, but remains an area to monitor as capital plans evolve .
  • Expect heavy focus from analysts on early CR/MRD and safety, maintenance of VEN/HMA dosing, and design readiness for a clean registrational path if triplet signals meet expectations .

Sources:

  • Q1 2024 earnings call transcript (May 14, 2024) .
  • Q1 2024 8-K/press release (May 14, 2024) .
  • Q4 2023 8-K/press release (Mar 26, 2024) .
  • Q3 2023 8-K/press release (Nov 9, 2023) .
  • S&P Global consensus: unavailable via connector (mapping) [SpgiEstimatesError].