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Avalo Therapeutics, Inc. (AVTX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 results: revenue of $0.19M vs $0.00M consensus (beat), and Primary EPS of -$2.74 vs -$1.52 consensus (miss).* Cash and cash equivalents ended 2024 at $134.5M, with runway “into at least 2027.” *
  • 2024 was “transformational,” with AVTX-009 advanced rapidly into the Phase 2 LOTUS HS trial; topline readout remains expected in 2026 (maintained from prior quarter).
  • Opex stepped up with LOTUS initiation and the AlmataBio IPR&D charge; 2024 R&D was $24.4M and G&A $17.2M; FY net loss was $35.1M despite large non-cash other income related to warrants.
  • Funding de-risked: $185M gross proceeds in 2024 financing (including $69.4M from warrant exercises in Nov), underpinning clinical execution and a second indication announcement plan.
  • Near-term stock catalysts: execution updates/enrollment in LOTUS, clarity on the second indication, and cash runway validation.

What Went Well and What Went Wrong

What Went Well

  • Strong balance sheet and runway: cash and cash equivalents at $134.5M at 12/31/24; management guides runway into at least 2027, reducing financing overhang.
  • Clinical execution on AVTX-009: IND activated in July 2024, first HS patient dosed in October 2024; Phase 2 LOTUS topline timing maintained for 2026.
  • Strategic momentum and leadership: CEO highlighted 2024 as “transformational,” with a focus on executing LOTUS and exploring broader AVTX-009 applications; appointment of a Chief Strategy Officer to guide pipeline planning in 2025.

What Went Wrong

  • EPS miss in Q4: Primary EPS of -$2.74 vs -$1.52 consensus, reflecting higher operating expenses and lack of material revenue contribution.* (See Financial Results)*
  • Revenue decline: 2024 total revenue fell to $0.44M from $1.92M in 2023 as legacy product revenue wound down; Q4 revenue was $0.19M, down from $0.25M in Q3.* *
  • Higher 2024 operating expenses: R&D rose to $24.4M (+$10.7M YoY) on LOTUS costs; G&A was $17.2M (+$6.9M YoY); FY net loss increased to $35.1M, though partly offset by non-cash warrant-related other income.

Financial Results

Quarterly revenue and EPS vs. prior quarters and consensus

Note: Periods are chronologically ordered (oldest → newest). Values with asterisks are from S&P Global consensus/actuals.

MetricQ2 2024Q3 2024Q4 2024
Revenue Actual ($USD)$0.00M*$0.25M*$0.19M*
Revenue Consensus ($USD)$0.00M*$0.00M*$0.00M*
Primary EPS Actual ($)N/A*N/A*-$2.74*
Primary EPS Consensus Mean ($)-$6.70*-$1.19*-$1.516*

Values retrieved from S&P Global.*

  • Cross-check: Q3 revenue actual of $0.25M aligns with company-reported Q3 product revenue of $0.249M.
  • FY revenue was $0.441M vs $1.924M in 2023 (YoY decline).

Selected annual P&L items (GAAP)

Metric ($USD Millions)FY 2023FY 2024
Total Revenues$1.92$0.44
Research & Development$13.78$24.44
General & Administrative$10.30$17.24
Acquired IPR&D$0.00$27.64
Net Loss($31.54)($35.13)
  • Management attributes higher 2024 opex to the AlmataBio IPR&D charge and increased LOTUS trial and corporate costs.

Liquidity KPIs

MetricQ2 2024 (6/30)Q3 2024 (9/30)Q4 2024 (12/31)
Cash & Cash Equivalents ($USD Millions)$93.43 $81.86 $134.55
Runway CommentaryRunway into 2027 Runway into at least 2027 Runway into at least 2027

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
LOTUS topline timingPhase 2 (HS)2026 (Q3 2024) 2026 (Q4 update) Maintained
LOTUS execution2025 prioritiesInitiation underway; first patient dosing targeted (Q2 2024) Focus on executing LOTUS through 2025 Maintained/Operationalized
Second indication for AVTX-009PipelineEvaluating additional immune-mediated disease; selection targeted Plans to announce a second indication Maintained, greater specificity
Cash runwayCorporateInto at least 2027 (Q3 2024) Into at least 2027 (Q4 update) Maintained

Earnings Call Themes & Trends

(No Q4 2024 earnings call transcript was found in our document set; themes reflect company press releases and 8-Ks.)

TopicPrevious Mentions (Q2 2024, Q3 2024)Current Period (Q4 2024)Trend
R&D execution (LOTUS trial)IND active; first patient enrollment expected in 2H24 First patient dosed Oct 2024; executing to 2026 topline Improving execution; timeline maintained
Funding & runway$93.4M cash (Q2); runway into 2027 $81.9M (Q3) then $134.5M (Q4) cash; runway into at least 2027 Strengthened via warrant proceeds
Pipeline expansionEvaluating second indication Plan to announce second indication Progressing toward disclosure
Leadership & orgNew CMO and CLO appointed (Q2) Chief Strategy Officer appointed (Jan 2025) Building strategic capabilities
RegulatoryIND activation announced in July 2024 [22] (referenced in Q2 PR) Continued trial execution under IND On plan

Management Commentary

  • “2024 was a transformational year for Avalo… Our primary focus in 2025 is executing the LOTUS trial to release data in 2026, while exploring broader applications for AVTX-009 and announcing a second indication.” — Dr. Garry Neil, CEO & Chairman.
  • “We made significant progress in the third quarter and have dosed the first HS patient in our Phase 2 LOTUS trial of AVTX-009… topline data anticipated in 2026.” — Dr. Garry Neil.
  • “We appreciate the outstanding support of our investors by fully exercising their warrants… the launch and execution of [our next indication] will benefit from our improved cash position and extended cash runway.” — Dr. Garry Neil.

Q&A Highlights

  • No Q4 2024 earnings call transcript was available in the company’s filings/press materials, so there are no Q&A highlights to report for this period.

Estimates Context

  • Q4 2024: Revenue $0.19M vs $0.00M consensus (beat); Primary EPS -$2.74 vs -$1.52 consensus (miss).*
  • Coverage depth was limited: Q4 EPS had 5 estimates; revenue had 6 estimates.*
  • Q3 2024: Actual revenue $0.25M vs $0.00M consensus; Primary EPS consensus -$1.19; actual EPS not available in S&P data (company reported basic EPS $0.98, not directly comparable to “Primary EPS”).*
  • Q2 2024: Revenue $0.00M vs $0.00M consensus; EPS consensus -$6.70; S&P actual EPS not available.*

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Funding risk is meaningfully reduced with $134.5M year-end cash and runway into at least 2027, enabling focus on clinical milestones.
  • The LOTUS Phase 2 trial is progressing on plan; topline remains slated for 2026, a key binary catalyst for shares.
  • Q4 printed a small revenue beat vs. zero expectations but an EPS miss, underscoring opex intensity as the program scales.*
  • FY 2024 opex (R&D $24.4M; G&A $17.2M) and the IPR&D charge reflect upfront investment; non-cash warrant mark-to-market meaningfully impacted quarterly GAAP earnings.
  • Near-term workstreams that may drive sentiment: LOTUS enrollment cadence, second-indication disclosure for AVTX-009, and any partnership signals.
  • With consensus expecting minimal revenue near-term, the story is driven by clinical execution and cash discipline; setback or delay commentary would likely move the stock disproportionately.*

Supporting Details and Citations

  • FY 2024 financials, business update, and balance sheet:
  • Q3 2024 financials and progress update:
  • Warrant exercise and proceeds:
  • Guidance consistency on 2026 LOTUS topline and runway:

Values retrieved from S&P Global.*