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Aptevo Therapeutics Inc. (APVO)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024: Net loss of $6.8M and diluted EPS of -$9.95; prior-year quarter benefited from a $9.7M gain and discontinued ops, resulting in net income of $2.8M and EPS of $17.38 .
  • Cash and equivalents were $10.3M at March 31, 2024; pro forma cash was $14.3M including an April 10 equity raise, highlighting near-term financing as a key focus .
  • Operational catalysts: APVO436 Phase 1b/2 dose optimization trial for frontline AML in combination with venetoclax + azacitidine remains on track for initiation in Q2 2024; ALG.APV-527 Phase 1 trial now dosing cohort 5 with >50% enrollment and encouraging stable disease durability in heavily pretreated breast cancer patients .
  • Consensus estimates via S&P Global were unavailable; a third-party source indicated an EPS estimate of -$12.84 versus actual -$9.95, implying a potential beat; treat non-SPGI data as directional only .

What Went Well and What Went Wrong

What Went Well

  • ALG.APV-527 clinical signal: One heavily pretreated breast cancer patient improved from progressive disease to long-lasting stable disease >11 months, transitioned to a higher dose with no new adverse events; another patient sustained stable disease for seven months, with biomarker evidence of biological activity .
  • APVO436 path to frontline AML: Company on track to initiate Phase 1b/2 dose optimization in Q2 2024 with triplet venetoclax + azacitidine + APVO436; prior data showed a 91% clinical benefit rate and manageable CRS (27% incidence, mostly grade 1–2) in venetoclax-naïve patients .
  • Cost discipline: R&D declined to $3.8M from $4.2M and G&A declined to $3.2M from $3.6M YoY for Q1, reflecting lower APVO436 trial costs ahead of the new study and lower employee/consulting expenses .

What Went Wrong

  • Year-over-year swing to loss: Absence of the $9.7M gain related to sale of a non-financial asset and lack of discontinued ops income drove a shift from Q1 2023 net income ($2.8M) to Q1 2024 net loss ($6.8M) .
  • Cash drawdown: Cash decreased to $10.3M at quarter-end from $16.9M at FY 2023, underscoring financing dependence despite pro forma $14.3M after April raise .
  • No revenue base: The company ceased reporting royalty revenue after Q1 2022; operating results remain driven by R&D/G&A with no product revenue, heightening reliance on external capital .

Financial Results

MetricQ2 2023Q3 2023Q1 2024
Revenue ($USD Millions)$0.0 $0.0 $0.0 (no revenue reported; see operating statement)
Net (Loss) Income ($USD Millions)$(7.948) $(6.334) $(6.834)
Diluted EPS ($USD)$(1.23) $(0.50) $(9.95)
R&D Expense ($USD Millions)$5.462 $3.887 $3.752
G&A Expense ($USD Millions)$2.716 $2.674 $3.231
Loss from Operations ($USD Millions)$(8.178) $(6.561) $(6.983)
Cash & Equivalents ($USD Millions)$21.006 $19.110 $10.250
Cash & Equivalents (Pro Forma, incl. Apr 10 raise) ($USD Millions)——$14.300

Notes:

  • Prior-year quarter detail for comparison: Q1 2023 net income $2.773M and EPS $17.38 due to $9.650M gain and $0.946M discontinued ops income .
  • FY-end cash baseline: $16.904M at Dec 31, 2023 .

Segment breakdown: Not applicable (no commercial segments reported) .

KPIs (clinical operations):

  • ALG.APV-527 enrollment and dosing: >50% enrolled; dosing cohort 5 of 6 .
  • ALG.APV-527 patient durability: SD >11 months (no new AEs after dose escalation) and a second patient with SD for seven months .
  • APVO436 prior study signal: 91% clinical benefit rate; CRS 27% (mostly grade 1–2); transitions to transplant achieved .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
APVO436 Phase 1b/2 dose optimization (frontline AML, triplet with venetoclax + azacitidine)Q2 2024Initiate 1H24 On track to initiate in Q2 2024 Maintained (timing refined)
ALG.APV-527 interim readout and dose escalation1H 2024Interim results expected 1H24; dose escalation ongoing Trial >50% enrolled; dosing cohort 5; potential for increased clinical benefit at higher doses Maintained (progress update)
Financing/cash runway2024Q3 2023 extended runway with $7M funding, potential $9.2M from warrants Pro forma cash $14.3M as of 3/31/24 including Apr 10 raise Maintained focus on financing

No explicit financial guidance on revenue, margins, or OpEx was provided in Q1 2024 materials .

Earnings Call Themes & Trends

No Q1 2024 earnings call transcript was found via internal document tools; IR site shows the press release and 10-Q, but no transcript is available for Q1 2024 . Themes below synthesize press releases across periods.

TopicPrevious Mentions (Q-2: Q3 2023)Previous Mentions (Q-1: FY 2023 release)Current Period (Q1 2024)Trend
R&D execution (APVO436)Planning for Phase 2 trials in relapsed/refractory and frontline AML; equity raise extended runway Intent to initiate open-label Phase 1b/2 in 1H24 for frontline AML On track to initiate dose optimization in Q2 2024 Progressing toward later-stage evaluation
R&D execution (ALG.APV-527)Phase 1 dose escalation ongoing in solid tumors Interim results expected 1H24 >50% enrolled; dosing cohort 5; durable SD in two patients Strengthening clinical signal; dose escalation continues
Regulatory/designation—APVO436 orphan drug designation for AML affirmed APVO436 orphan status described in program summary Stable regulatory status
Safety profile—Prior trials indicate manageable safety; plan for optimization ALG.APV-527 well-tolerated; APVO436 CRS incidence 27% mostly grade 1–2 Generally manageable safety in early-stage settings
Financing/cash runway$7M raised in Aug/Nov 2023; potential $9.2M via warrants FY cash $16.9M Q1 cash $10.3M; pro forma $14.3M with Apr raise Cash down sequentially; ongoing financing support

Management Commentary

  • “Aptevo has had an exciting first quarter… we are particularly enthusiastic about one breast cancer patient in our ALG.APV-527 trial who has remained on study with stable disease for more than eleven months… [and] we plan to initiate our APVO436 dose optimization trial in frontline AML patients this quarter.” — Marvin White, President & CEO .
  • “We are pleased with the progress of the ALG.APV-527 Phase 1 clinical program… We believe this drug has the potential to impact patients in large patient populations…” — Dirk Huebner, MD, CMO (FY 2023 release) .
  • External clinical commentary on APVO436 triplet regimen noted encouraging response rates and duration of remission with manageable CRS, positioning APVO436 as combinable with venetoclax + azacitidine standard of care (Q2 2023 release) .

Q&A Highlights

  • No Q1 2024 earnings call transcript could be located via internal tools or IR links; therefore, Q&A themes and guidance clarifications are unavailable for this quarter .

Estimates Context

  • S&P Global consensus estimates were unavailable at the time of analysis (tool access limit). Anchor comparisons to SPGI could not be performed; therefore, vs-estimates columns are shown as N/A in tables.
  • A third-party source reported an EPS estimate of -$12.84 for Q1 2024 versus actual -$9.95, implying a potential beat; treat as directional only until confirmed via SPGI .

Key Takeaways for Investors

  • Near-term catalyst: APVO436 frontline AML Phase 1b/2 dose optimization initiation in Q2 2024 with triplet venetoclax + azacitidine + APVO436; monitor first-patient-in and early safety/efficacy signals as potential stock movers .
  • ALG.APV-527 solid tumor program shows durable stable disease signals and ongoing dose escalation; watch for higher-dose cohort data and any interim readouts that strengthen the clinical thesis .
  • Operating structure remains pre-revenue; cash burn and financing cadence are critical—pro forma cash was $14.3M post-April raise; expect continued capital strategy disclosures .
  • Year-over-year comparison is distorted by one-time gains and discontinued ops in Q1 2023; focus on operating loss trajectory and cost discipline (R&D/G&A) as management reallocates spend to priority trials .
  • With orphan status in AML and manageable safety seen to date, incremental data could de-risk APVO436 and improve funding optionality; watch for site activations and enrollment pace .
  • Estimates context remains limited without SPGI consensus; any perceived beat/miss should be validated against authoritative sources before trading decisions .
  • Tactical positioning: positive clinical catalysts can drive volatility; consider risk-managed exposure around trial initiations and interim updates while monitoring cash runway and dilution risk .