[8-K] Avalo Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

Avalo Therapeutics reported a clinical milestone: it has completed enrollment in its Phase 2 LOTUS Trial evaluating AVTX-009 for hidradenitis suppurativa. The company disclosed the update via a press release furnished as Exhibit 99.1 to this report, dated October 29, 2025. This marks the transition from recruitment to data collection and analysis for the study.

Insights

Biopharma clinical development analyst

Enrollment completion advances AVTX-009 to the data phase.

Enrollment completion in a Phase 2 trial is a key operational step: it locks the study cohort and starts the clock toward efficacy and safety readouts. Here, Avalo completed enrollment in the LOTUS study of AVTX-009 in hidradenitis suppurativa.

While not a readout, this milestone reduces recruitment risk and frames the next catalyst as trial results, which will determine program momentum. Further specifics on endpoints, timelines, or statistical plans would typically appear in the accompanying press release.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549  

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 29, 2025

AVALO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)  

Delaware

(State or other jurisdiction of incorporation)

001-37590						45-0705648
(Commission File Number)						(IRS Employer Identification No.)

1500 Liberty Ridge Drive, Suite 321, Wayne, Pennsylvania 19087

(Address of principal executive offices) (Zip Code)

Registrant’s Telephone Number, Including Area Code: (410) 522-8707

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class			Trading Symbol(s)			Name of each exchange on which registered
Common Stock, $0.001 Par Value			AVTX			Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01    Other Events.

On October 29, 2025, Avalo Therapeutics, Inc. issued a press release announcing the completion of enrollment of its Phase 2 LOTUS Trial of AVTX-009 for the treatment of hidradenitis suppurativa. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01    Financial Statements and Exhibits.

(d)    Exhibits:

Exhibit No.						Description
99.1						Press Release, dated October 29, 2025.
104						The cover pages of this Current Report on Form 8-K, formatted in Inline XBRL.

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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: October 29, 2025						By:			/s/ Christopher Sullivan
									Christopher Sullivan
									Chief Financial Officer

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