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Aptevo Therapeutics Inc. (APVO)·Q3 2024 Earnings Summary

Executive Summary

  • Initiated the mipletamig (APVO436) Phase 1b/2 “RAINIER” dose-optimization trial in frontline AML and presented positive ALG.APV-527 interim data (60% stable disease) at ESMO; additional data slated for SITC, marking notable clinical execution in Q3 2024 .
  • Operating profile improved: net loss narrowed to $5.1M from $6.3M YoY; diluted EPS improved to $(0.48) vs $(22.16) YoY; R&D and G&A both declined YoY, reflecting cost discipline .
  • Cash and equivalents were $7.8M at quarter-end; company raised $5.75M via two financings during Q3 to support continued development and runway .
  • No quantitative financial guidance provided; near-term stock reaction catalysts are clinical readouts (RAINIER initiation progress, ALG.APV-527 updates) and financing developments .

What Went Well and What Went Wrong

What Went Well

  • Initiated RAINIER: “We were thrilled to initiate the next phase of our mipletamig development program—a robust Phase 1b/2 trial for frontline AML patients, combining mipletamig with venetoclax and azacitidine” — Marvin White, President & CEO .
  • Solid tumor program momentum: 60% of efficacy-evaluable patients achieved stable disease in ALG.APV-527 monotherapy; longest SD >11 months in breast cancer; safety/tolerability positive; biomarker activity confirmed .
  • Cost control: R&D decreased to $3.1M (from $3.9M YoY) and G&A to $2.1M (from $2.7M YoY), aiding sequential and YoY loss improvement .

What Went Wrong

  • Continued losses: Net loss of $5.1M and lack of commercial revenue; operating loss remains sizeable at $5.2M .
  • Cash burn and limited cash: Cash and equivalents were $7.8M at quarter-end, necessitating ongoing external financing to sustain programs .
  • Estimates visibility absent: Wall Street consensus EPS/revenue for Q3 2024 were unavailable via S&P Global at time of analysis, limiting beat/miss assessment [GetEstimates error: Daily Request Limit Exceeded].

Financial Results

Income Statement and EPS (USD Millions unless noted)

MetricQ1 2024Q2 2024Q3 2024
Research & Development$3.752 $3.643 $3.103
General & Administrative$3.231 $2.381 $2.110
Loss from Operations$(6.983) $(6.024) $(5.213)
Other Income (Expense), Net$0.149 $0.141 $0.112
Net Loss$(6.834) $(5.883) $(5.101)
Diluted EPS$(9.95) $(1.67) $(0.48)
Shares Used (Diluted)686,735 3,519,875 10,548,470

Balance Sheet Highlights

MetricQ1 2024Q2 2024Q3 2024
Cash and Cash Equivalents ($M)$10.250 $8.066 $7.753
Total Assets ($M)$17.629 $14.921 $15.146
Total Liabilities ($M)$11.526 $10.458 $10.726
Stockholders’ Equity ($M)$6.103 $4.463 $4.420

Q3 2024 YoY Comparisons

MetricQ3 2023Q3 2024YoY Change
R&D Expense ($M)$3.887 $3.103 $(0.784)
G&A Expense ($M)$2.674 $2.110 $(0.564)
Other Income, Net ($M)$0.227 $0.112 $(0.115)
Net Loss ($M)$(6.334) $(5.101) +$1.233
Diluted EPS$(22.16) $(0.48) +$21.68

Estimates vs. Actuals (Q3 2024)

MetricConsensusActualSurprise
Revenue ($M)N/A (S&P Global unavailable)N/A (no revenue disclosed) N/A
Primary EPS ($)N/A (S&P Global unavailable)$(0.48) N/A

Note: Consensus unavailable via S&P Global at time of analysis due to API limits or coverage constraints; no values retrieved.

KPIs (Clinical Program Progress)

KPIQ1 2024Q2 2024Q3 2024
APVO436 (mipletamig) program milestonePlanned initiation of Phase 1b/2 in 2Q 2024 Finalizing launch plans; dose optimization to start in Q2 Phase 1b/2 “RAINIER” initiated in frontline AML
ALG.APV-527 efficacyLong-lasting SD in heavily pretreated breast cancer; >11 months; dosing cohort 5 60% SD rate emerging in interim context; dosing higher cohorts; >90% enrolled 60% of 15 evaluable pts SD; longest SD >11 months; colon cancer SD >4 months
ALG.APV-527 safety/tolerabilityWell-tolerated; MTD not reached Well-tolerated; MTD not identified; measurable PK Positive safety/tolerability; MTD not identified; biomarker activity confirmed

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial guidance (revenue, margins, OpEx, tax, etc.)FY/Q3 2024None providedNone providedMaintained (no guidance)
Program milestones2H 2024APVO436 Phase 1b/2 initiation planned APVO436/Rainier initiated; ALG.APV-527 interim data presented; SITC planned Nov 8Raised specificity (execution milestones achieved)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024 and Q1 2024)Current Period (Q3 2024)Trend
APVO436 (mipletamig) frontline AML strategyQ1: Initiation expected 2Q 2024; CRO engaged; dose optimization design . Q2: Finalizing launch; initiating dose optimization; combination with venetoclax+azacitidine .RAINIER Phase 1b/2 initiated; dose optimization followed by Phase 2 .Positive execution momentum.
ALG.APV-527 clinical activityQ1: Long-lasting SD in breast cancer; dosing cohort 5; biomarker activity . Q2: >90% enrolled; well-tolerated; measurable PK; biomarker activity .60% SD in evaluable patients; longest SD >11 months; safety favorable; biomarker activity confirmed; additional data at SITC .Strengthening activity/safety profile.
Financing and cash runwayQ1: Pro forma cash $14.3M incl April raise . Q2: $2.75M registered direct offering; runway extended into 2025 .Raised $5.75M across two financings in Q3 .Continued access to capital; dilution increasing.

Note: An earnings call transcript for Q3 2024 was not found in the document set; themes reflect press release disclosures [ListDocuments returned none; SearchDocuments returned none].

Management Commentary

  • “Aptevo achieved significant clinical progress in both programs this quarter... This trial structure is informed by the encouraging results from our dose expansion trial, reinforcing our belief in mipletamig's transformative potential for AML patients.” — Marvin White, President & CEO .
  • “We also released positive interim data on our solid tumor drug, ALG.APV-527... with 60% of evaluable patients achieving stable disease in monotherapy... The progress we’re witnessing, combined with nearly $6 million in capital secured in the quarter, sets a promising stage for the fourth quarter and lays the groundwork for continued successes into 2025.” — Marvin White .

Q&A Highlights

  • No Q3 2024 earnings call transcript was available in the document set; Q&A highlights and clarifications cannot be assessed from primary sources [ListDocuments returned none; SearchDocuments returned none].

Estimates Context

  • S&P Global consensus EPS and revenue estimates for Q3 2024 were unavailable at time of analysis due to API limits or potential coverage constraints; as a result, beat/miss vs. Street could not be determined [GetEstimates error: Daily Request Limit Exceeded].
  • Given the company’s pre-commercial stage and lack of disclosed revenue, future estimate revisions likely hinge on clinical milestones (RAINIER dose optimization data, ALG.APV-527 higher-dose cohorts and biomarker outputs) rather than near-term P&L .

Key Takeaways for Investors

  • Clinical execution is the principal value driver: RAINIER initiation in frontline AML materially advances mipletamig (APVO436) and sets up efficacy/safety readouts in the coming periods .
  • ALG.APV-527 demonstrates encouraging activity (60% SD), favorable tolerability, and biomarker-confirmed biology, with additional data flow at SITC and ongoing dose escalation — a multi-tumor optionality story .
  • Operating discipline improved YoY and sequentially (lower R&D/G&A), narrowing net loss; however, the absence of revenue keeps funding needs and execution risk elevated .
  • Cash of $7.8M at Q3-end plus $5.75M raised in the quarter provides near-term runway; monitor dilution and listing compliance alongside capital markets access .
  • No financial guidance; stock likely reacts to clinical catalysts (RAINIER progress, ALG.APV-527 higher-dose signs of activity) and financing trajectory .
  • Prior quarter context shows consistent narrative progression: Q1 planned initiation → Q2 finalizing → Q3 initiated, indicating strong operational follow-through .
  • Watch for any safety signals, enrollment cadence, and translational biomarker consistency as programs advance; these will shape medium-term thesis more than near-term income statement .