Avalo Therapeutics, Inc.

Avalo Therapeutics, Inc. is a clinical-stage biotechnology company focused on immune dysregulation and inflammatory disease. Its lead program is AVTX-009, an anti-IL-1β monoclonal antibody being developed for hidradenitis suppurativa and potentially other immune-mediated indications. The company is still in the development phase and does not yet have commercial product revenue, so its value is tied primarily to clinical execution, regulatory progress, and business development optionality. Avalo also evaluates opportunities to out-license programs, indications, or geographies as part of its path to value creation.

−123 018,6 %

−132 642,4 %

−86,6 %

8.14

8.14

— Avalo Therapeutics, Inc.
%
Lead clinical asset development70% Development of AVTX-009 and related clinical-stage work in immune-mediated disease.
Clinical trial operations20% Sponsor-led execution of the LOTUS Phase 2 trial across multiple countries.
Business development and licensing10% Out-licensing, in-licensing, and partnering activities for programs and geographies.

Avalo does not sell commercial medicines today; its primary counterparties are clinical trial participants,...

  • Clinical trial participantsprimary

    Adults with moderate to severe hidradenitis suppurativa enrolled to evaluate AVTX-009 safety and efficacy.

  • Clinical investigators and trial sitesprimary

    Hospitals, clinics, and research centers that execute the LOTUS protocol and generate the data package.

  • Strategic pharmaceutical partnerssecondary

    Companies that may license AVTX-009 rights, fund development, or collaborate on specific indications or regions.

  • Future prescribers and patientsemerging

    Dermatology and immunology stakeholders who would use the product if it reaches approval and commercialization.

Avalo’s current operating footprint is centered in the United States, where it is headquartered and where a meaningful...

  • •Headquartered in the United States
  • •Phase 2 LOTUS trial runs across the U.S. and multiple foreign markets
  • •European trial sites expand patient recruitment and data diversity
  • •Australia and Turkey add further geographic reach for clinical operations
  • •Geographic expansion supports future out-licensing by indication or region

Avalo’s near-term strategy is to advance AVTX-009 through the Phase 2 LOTUS trial and prepare for the next stage of...

01
Advance AVTX-009 through Phase 2 LOTUSshort-term

Clinical data is the main value driver for a pre-commercial biotech and determines whether the asset can progress or be partnered.

02
Expand AVTX-009 into additional indicationsmedium-term

A broader label opportunity can increase the asset’s commercial value and improve partnering leverage.

03
Monetize through partnering and out-licensingmedium-term

Non-dilutive capital and shared development risk are important for a company with ongoing operating losses.

Avalo’s biggest risk is clinical development failure, since the company’s value depends heavily on AVTX-009 and the...

critical

Dependence on AVTX-009 and the LOTUS trial

The company’s near-term value creation is concentrated in a single lead asset and one key Phase 2 study.

Scope
Clinical development and pipeline concentration
Materiality
high
high

Need for future financing and potential dilution

Avalo has a history of operating and cash losses and may need equity or partnering capital to fund development.

Scope
Liquidity and capital markets
Materiality
high
high

Regulatory and approval uncertainty

Positive clinical results do not guarantee FDA or ex-U.S. approval, and the approval path may require additional studies.

Scope
FDA and foreign regulatory agencies
Materiality
high
medium

Clinical execution and enrollment delays

Multinational trials depend on site activation, patient recruitment, and protocol adherence across many countries.

Scope
Trial operations
Materiality
medium
medium

Competitive landscape in immune-mediated disease

Competing biologics and emerging therapies could reduce the commercial opportunity even if AVTX-009 succeeds.

Scope
Hidradenitis suppurativa and inflammatory disease markets
Materiality
medium
Clinical trial accruals
Can shift reported operating loss between periods
Fair value of derivative liabilities
Can materially distort net income or loss
Stock-based compensation
Raises reported expenses without immediate cash outflow
Revenue recognition for future licensing deals
Could create lumpy revenue recognition

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: 11/08/2026