Avalo Therapeutics, Inc.

Company overview

Avalo Therapeutics is a clinical-stage biotechnology company developing IL-1β–based treatments for immune-mediated inflammatory diseases, with a primary focus on hidradenitis suppurativa (HS).

Lead product candidate

• Abdakibart (AVTX-009): a high-affinity humanized IgG4 anti-IL-1β monoclonal antibody.
• Current program: LOTUS, a Phase 2 trial in HS.
• Timeline:
  • LOTUS enrolled in 2024; enrollment completed in October 2025.
  • Topline data expected in the second quarter of 2026.
  • Phase 3 planning is contingent on the LOTUS readout.

Pipeline and strategy

• Primary focus on abdakibart (AVTX-009) for HS.
• Legacy/non-core programs not actively pursued: AVTX-002 (quisovalimab), AVTX-006, AVTX-008, AVTX-913.
• Strategy includes pursuing targeted preclinical/clinical assets and opportunistic out-licensing.

Licensing and acquisition agreements

• Eli Lilly license: worldwide exclusive license to abdakibart from Eli Lilly and Company. Royalties of 5–15% on net sales; milestone payments up to $70 million to Lilly; up to $650 million in sales-based milestones. Agreements remain in effect until the last-to-expire royalty term; parties may terminate for cause.
• Leap Therapeutics / AlmataBio arrangements: acquisition of AlmataBio in Q1 2024 and a Leap agreement for abdakibart rights. Up to $70 million in milestone payments to Leap; additional development milestones payable to former AlmataBio stockholders (for example, $5.0 million upon first patient dosed in a Phase 2 HS trial; $15.0 million upon first patient dosed in a Phase 3 trial).
• October 2024 milestone: $5.0 million paid under the AlmataBio-related agreements.

Intellectual property

• U.S. composition-of-matter patent for abdakibart expired February 2026.
• The company relies on biologics regulatory exclusivity (12 years in the U.S.; up to 10 years in the EU) and on method and formulation patent applications filed in the U.S. and worldwide that may extend protection beyond the expired composition patent.

Manufacturing

• No internal manufacturing facilities; uses third-party contract development and manufacturing organizations (CDMOs).
• Currently relies on a single CDMO for abdakibart clinical supply; manufacturing is conducted under cGMP and carries the typical risks of third-party arrangements.

Commercialization and market access

• No approved products or product revenue to date.
• The company will need to build or partner for sales, marketing, and market access if abdakibart is approved.
• Competitive landscape includes other IL-1β–targeting therapies and existing HS treatments, with high competition for durable disease control and payer access.

Financial position (key 2025 data)

• Cash and equivalents plus short-term investments: $98.3 million (as of 12/31/2025).
• Current liabilities: $12.9 million (as of 12/31/2025).
• Revenue: none.
• Net loss for the year ended 12/31/2025: $78.3 million.
• Accumulated deficit as of 12/31/2025: $448.5 million.
• Cash runway: management believes available funds are sufficient to support operations into 2028 to advance abdakibart and other programs, under current plans and assumptions.

Employees and operations

• Total full-time employees: 33 (as of 12/31/2025); 18 in research and development.
• No union representation.
• Primary functions: R&D, regulatory, and corporate.
• Headquarters: Wayne, PA. Public company listed on Nasdaq.

Customers and revenue model

• No customers or product sales revenue to date.
• Future revenues depend on regulatory approvals, successful commercialization, and market access/reimbursement.

Runway, capital needs, and financing

• No committed external financing at the time of the filing.
• Management expects additional capital will be required for continued development, manufacturing scale-up, and potential Phase 3 progression.
• Current cash position is intended to fund operations into 2028, subject to clinical timelines and expenditures.

Public listing and governance

• Listed on The Nasdaq Stock Market (Nasdaq Capital Market).
• Governance provisions and risk considerations align with those typical of clinical-stage biotech companies, including potential dilution from future equity issuances and capital market risk.

Summary

Avalo is advancing abdakibart (AVTX-009) in HS through the Phase 2 LOTUS trial, with topline data expected in Q2 2026 and potential Phase 3 planning contingent on results. The company depends on third parties for manufacturing and on licensing agreements that include royalties and milestone obligations. Financially, Avalo has no product revenue, a material accumulated deficit, and cash resources it expects will support operations into 2028 under current plans.