Avalo Therapeutics reports Q3 2026 financial results

On November 5, 2026, Avalo Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2026.¹ A copy of the press release is furnished hereto as Exhibit 99.1.²

Information in this Item 2.02 (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934³, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

(d) Exhibits:

Exhibit No. Description

99.1 Press release, dated November 5 , 2026.⁴

104 Cover Page Interactive Data File (embedded within the Inline XBRL document)⁴

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

AVALO THERAPEUTICS, INC.

Date: November 5, 2026 By: /s/ Christopher Sullivan⁵

Christopher Sullivan⁵

Chief Financial Officer⁵

Avalo Therapeutics Reports Third Quarter 2026 Financial Results and Recent Business Updates

• Advancing abdakibart toward a registrational Phase 3 program in hidradenitis suppurativa, with initiation planned for the first half of 2027¹⁰

WAYNE, Pa., Nov. 5, 2026 – Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical-stage biotechnology company focused on developing therapies targeting the IL-1β pathway for immune-mediated inflammatory diseases, today reported financial results for the third quarter of 2026 and provided a business update.

"LOTUS provides a strong clinical foundation for advancing abdakibart toward registrational development in hidradenitis suppurativa," said Garry Neil, MD, Chief Executive Officer of Avalo. "The efficacy and safety results observed across both dosing regimens, together with the potential for once-monthly administration, give us confidence in abdakibart's potential to become an important new treatment option for patients with HS. Our priority is to translate these findings into a rigorous Phase 3 program designed to establish clinically meaningful and durable benefit, informed by upcoming regulatory feedback. We are also advancing AVTX-010, our next-generation, long-acting IL-1β antibody, as we expand our pipeline in IL-1β-mediated diseases. Our strong financial position allows us to pursue these priorities with disciplined capital allocation and investment tied to clear development milestones."

Recent Corporate Highlights and Upcoming Anticipated Milestones

• Abdakibart (AVTX-009): Continued preparations for a registrational Phase 3 program in hidradenitis suppurativa (HS). Avalo expects feedback from the U.S. Food and Drug Administration on its proposed development plan by year-end 2026 and plans to initiate the Phase 3 program in the first half of 2027.

• AVTX-010: Continued development of its next-generation, Fc-engineered, long-acting anti-IL-1β monoclonal antibody, with an Investigational New Drug (IND) submission anticipated in the first half of 2027. AVTX-010 is being developed for potential use in HS and other inflammatory diseases.

• Phase 2 LOTUS data: Presented a late-breaking oral presentation and poster at the 2026 European Academy of Dermatology and Venereology (EADV) Congress.

Third Quarter 2026 Financial Update

• Cash, cash equivalents and investments were $462.8 million as of September 30, 2026. Net cash used in operating activities was $49.2 million for the nine months ended September 30, 2026.⁷ Avalo's current cash, cash equivalents, and investments are expected to fund operations into 2029.

• Research and development expenses were $15.0 million for the third quarter of 2026⁸, an increase of $1.4 million from the third quarter of 2025, primarily driven by increased CMC expenses related to manufacturing activities for AVTX-010 and abdakibart, as well as increased stock-based compensation expense and salary and related costs. These increases were partially offset by lower clinical expenses as LOTUS trial and related activities decreased following the topline data readout in May 2026.

• General and administrative expenses were $8.4 million for the third quarter of 2026⁸, an increase of $2.8 million from the third quarter of 2025, primarily driven by increased stock-based compensation expense and salary and related costs.

• Net loss was $18.9 million for the third quarter of 2026⁹, a decrease of $11.7 million from the third quarter of 2025. The difference was mainly driven by a $4.2 million increase in operating expenses due to the $1.4 million increase in research and development expenses and $2.8 million increase in general and administrative expenses, as discussed above, more than offset by the impact of the change in fair value related to the derivative liability. Basic and diluted net loss per share was $0.34 and $2.19 for the third quarters of 2026 and 2025, based on 55,060,404 and 14,000,451 weighted average common shares outstanding, respectively.⁹

Consolidated Balance Sheets

Mezzanine equity:

Series D Preferred Stock—$0.001 par value; 0 and 1 share of Series D Preferred Stock authorized at September 30, 2026 and December 31, 2025, respectively; 0 and 1 share of Series D Preferred Stock issued and outstanding at Septem