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  4. [8-K] Avalo Therapeutics, Inc. Reports Material Event

Avalo Therapeutics (NASDAQ: AVTX) details Q2 loss, $472.2M cash runway

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Avalo Therapeutics, Inc. reported second quarter 2026 results and business updates for its IL‑1β‑focused pipeline. The company plans to initiate a registrational Phase 3 program of abdakibart in hidradenitis suppurativa in the first half of 2027 and expects to submit an IND for its next‑generation anti‑IL‑1β antibody AVTX‑010 in the first half of 2027. It also appointed Ron Philip to the board and was added to the Russell 2000 and 3000 Indexes.

Cash, cash equivalents and investments totaled $472.2 million as of June 30, 2026 and are expected to fund operations into 2029. Net cash used in operating activities was $37.7 million for the first half of 2026. Second quarter 2026 research and development expenses were $23.4 million, up $9.3 million year over year, primarily due to a $10.0 million development milestone and other costs for abdakibart in HS. General and administrative expenses were $8.1 million, up $2.9 million, mainly from stock‑based compensation. Net loss was $36.4 million, an increase of $15.6 million year over year, with basic and diluted net loss per share of $0.83 versus $1.92 in the prior‑year quarter.

Positive

  • Avalo ended the quarter with $472.2 million in cash, cash equivalents and investments, which it expects will fund operations into 2029, supporting its planned abdakibart Phase 3 program and AVTX‑010 development.

Negative

  • Second quarter 2026 net loss increased by $15.6 million year over year to $36.4 million, driven by higher research and development and general and administrative expenses.

Filing Explained

As of June 30, 2026, Avalo Therapeutics reported 52,900,692 common shares issued and outstanding, versus 18,512,757 at December 31, 2025; this increases the common-share base against which existing holders’ ownership percentages are measured.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash, cash equivalents and investments $472.2 million As of June 30, 2026, expected to fund operations into 2029
Net cash used in operating activities $37.7 million For the six months ended June 30, 2026
Research and development expenses Q2 2026 $23.4 million Second quarter 2026, a $9.3 million increase versus second quarter 2025
General and administrative expenses Q2 2026 $8.1 million Second quarter 2026, a $2.9 million increase versus second quarter 2025
Net loss Q2 2026 $36.4 million Second quarter 2026, a $15.6 million increase versus second quarter 2025; EPS $0.83
Weighted average common shares outstanding Q2 2026 43,602,044 shares Basic and diluted weighted average common shares for the quarter ended June 30, 2026
registrational Phase 3 program medical
"plans to initiate a registrational Phase 3 program evaluating abdakibart in HS"
Investigational New Drug (IND) application regulatory
"expects to submit an Investigational New Drug (IND) application in the first half of 2027"
An investigational new drug (IND) application is a formal request submitted to a drug regulator asking permission to begin testing a new medicine in people. It compiles lab results, manufacturing details and proposed human trial plans so regulators can judge safety before human studies start; for investors, an accepted IND is a key milestone that opens the clinical development pathway and can materially change a company’s risk profile and potential value, like getting a license to road-test a prototype.
derivative liability financial
"Change in fair value of derivative liability"
A derivative liability is an obligation a company owes because of a derivatives contract—such as an option, future, swap, or forward—that has moved against it and now has negative value. Think of it like a settled bet that turned into a bill: if market moves go the other way, the company may have to pay cash or deliver assets. Investors care because these liabilities can create sudden losses, add leverage or counterparty risk, and change a company’s true financial exposure beyond its everyday operations.
contingent consideration financial
"Change in fair value of contingent consideration"
Contingent consideration is an additional payment agreed when one company buys another that will be paid later only if specific future targets are met, such as revenue, profit, or regulatory milestones. It matters to investors because it shifts risk between buyer and seller and affects the acquiring company's future cash flow and reported value — like promising a bonus after results are proven.
accumulated other comprehensive (loss) income financial
"Accumulated other comprehensive (loss) income"
Accumulated other comprehensive (loss) income is a running total on a company’s balance sheet that captures certain unrealized gains and losses that are excluded from regular profit and loss, such as currency translation shifts, some investment value changes, and pension plan adjustments. Think of it like value swings recorded in a side ledger for items not yet sold; it matters to investors because large or growing balances can signal hidden volatility or future effects on shareholders’ equity when those unrealized items are settled.
monoclonal antibody medical
"a long-acting next-generation anti-IL-1β monoclonal antibody"
A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.
Net loss Q2 2026 $36.4 million Increase of $15.6 million versus the second quarter of 2025
Research and development expense Q2 2026 $23.4 million Increase of $9.3 million versus the second quarter of 2025
General and administrative expense Q2 2026 $8.1 million Increase of $2.9 million versus the second quarter of 2025
Guidance

Cash, cash equivalents and investments are expected to fund operations into 2029.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What net loss did Avalo Therapeutics (AVTX) report for the second quarter of 2026?
Avalo reported a second quarter 2026 net loss of $36.4 million. This represented a $15.6 million increase from the prior‑year quarter, mainly due to higher R&D and G&A expenses, including a $10.0 million development milestone for abdakibart.

How much cash and investments did Avalo Therapeutics (AVTX) have as of June 30, 2026?
As of June 30, 2026, Avalo held $472.2 million in cash, cash equivalents and investments. The company expects this capital to fund operations into 2029, providing runway to progress abdakibart into Phase 3 and advance AVTX‑010 toward clinical development.

What are Avalo Therapeutics’ (AVTX) plans for abdakibart after the second quarter 2026 update?
Avalo plans to start a registrational Phase 3 program of abdakibart in hidradenitis suppurativa in the first half of 2027. This follows positive topline Phase 2 LOTUS results in HS and securing capital to take the program into late‑stage development.

What is AVTX-010 in Avalo Therapeutics’ (AVTX) pipeline?
AVTX‑010 is a long‑acting next‑generation anti‑IL‑1β monoclonal antibody. It is Fc‑engineered to extend half‑life while preserving abdakibart’s pharmacology and specificity, with an IND submission planned for the first half of 2027 for potential use in HS and other inflammatory disorders.

How long does Avalo Therapeutics (AVTX) expect its cash runway to last based on the Q2 2026 update?
Avalo expects its $472.2 million in cash, cash equivalents and investments to fund operations into 2029. This projected runway supports ongoing operations, planned Phase 3 development of abdakibart in hidradenitis suppurativa, and advancement of the AVTX‑010 program.

What were Avalo Therapeutics’ (AVTX) R&D and G&A expenses in the second quarter of 2026?
In second quarter 2026, R&D expenses were $23.4 million, up $9.3 million year over year, largely from a $10.0 million abdakibart milestone and HS development costs. G&A expenses were $8.1 million, a $2.9 million increase mainly due to stock‑based compensation.
0001534120false00015341202026-08-062026-08-06


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): August 6, 2026

AVALO THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)  
Delaware
(State or other jurisdiction of incorporation)
001-3759045-0705648
(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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 Par ValueAVTXNasdaq 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 2.02    Results of Operations and Financial Condition.

On August 6, 2026, Avalo Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2026. A copy of the press release is furnished hereto as Exhibit 99.1.

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 1934, 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.

Item 9.01    Financial Statements and Exhibits.

(d)    Exhibits:

Exhibit No. Description
99.1
Press release, dated August 6, 2026.
104Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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: August 6, 2026By:/s/ Christopher Sullivan
Christopher Sullivan
Chief Financial Officer



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Exhibit 99.1

avalo-logoxblk1.jpg

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

•Plans to initiate a registrational Phase 3 program evaluating abdakibart in hidradenitis suppurativa (HS) in the first half of 2027
•Expanded pipeline with AVTX-010, a long-acting next-generation anti-IL-1β antibody, with IND submission planned for the first half of 2027
•Appointed Ron Philip to the Board of Directors
•Cash, cash equivalents and investments of $472.2 million as of June 30, 2026, expected to provide runway into 2029

WAYNE, PA., August 6, 2026 — Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases, today announced business updates and financial results for the second quarter of 2026.

“In the second quarter, we achieved the key objectives that positioned Avalo for its next phase of growth,” said Garry Neil, MD, Chief Executive Officer of Avalo. “We delivered positive topline Phase 2 LOTUS results for abdakibart in HS, secured the capital to take it into a registrational Phase 3 program in HS, and expanded our pipeline with AVTX-010, a long-acting next-generation anti-IL-1β antibody. Our focus now is execution – starting with advancing abdakibart, which we believe has the potential to offer best in disease efficacy, safety and dosing convenience, toward Phase 3 initiation in HS as well as building a broader IL-1β franchise.”

Recent Corporate Highlights and Upcoming Anticipated Milestones

•Avalo plans to initiate a registrational Phase 3 program evaluating abdakibart in HS in the first half of 2027.
•Announced the advancement of AVTX-010, a long-acting next-generation anti-IL-1β monoclonal antibody with the potential for development in HS as well as other inflammatory disorders. The Company expects to submit an Investigational New Drug (IND) application in the first half of 2027.
•Appointed Ron Philip to its Board of Directors. Ron contributes deep strategic and commercial expertise, with a proven track record of bringing novel therapies to market.
•Added to the Russell 2000® and Russell 3000® Indexes as part of the FTSE Russell annual reconstitution.

Second Quarter 2026 Financial Update:

•Cash, cash equivalents and investments were $472.2 million as of June 30, 2026. Net cash used in operating activities was $37.7 million for the six months ended June 30, 2026. Avalo’s current cash, cash equivalents, and investments are expected to fund operations into 2029.
•Research and development expenses were $23.4 million for the second quarter of 2026, an increase of $9.3 million from the second quarter of 2025, driven by the recognition of a $10.0 million development milestone for abdakibart, as well as costs related to and supporting the development of abdakibart in HS.
•General and administrative expenses were $8.1 million for the second quarter of 2026, an increase of $2.9 million from the second quarter of 2025, primarily driven by stock-based compensation expense.

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•Net loss was $36.4 million for the second quarter of 2026, an increase of $15.6 million from the second quarter of 2025. The difference was mainly driven by a $12.2 million increase in operating expenses due to the $9.3 million increase in research and development expenses and $2.9 million increase in general and administrative expenses, as discussed above. Basic and diluted net loss per share was $0.83 and $1.92 for the second quarters of 2026 and 2025, based on 43,602,044 and 10,829,760 weighted average common shares outstanding, respectively.



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Consolidated Balance Sheets
(In thousands, except share and per share data)
June 30, 2026December 31, 2025
(unaudited)
Assets
Current assets:
Cash and cash equivalents$85,382 $15,858 
Short-term investments314,894 82,478 
Prepaid expenses and other current assets7,607 6,913 
Restricted cash, current portion49 37 
Total current assets407,932 105,286 
Long-term investments71,878 — 
Property and equipment, net288 460 
Goodwill10,502 10,502 
Restricted cash, net of current portion183 210 
Total assets$490,783 $116,458 
Liabilities, mezzanine equity and stockholders’ equity
Current liabilities:
Accounts payable$3,347 $137 
Accrued expenses and other current liabilities17,783 12,803 
Total current liabilities21,130 12,940 
Royalty obligation2,000 2,000 
Deferred tax liability, net463 434 
Derivative liability, non-current18,530 18,000 
Other long-term liabilities— 35 
Total liabilities42,123 33,409 
Mezzanine equity:
Series D Preferred Stock—$0.001 par value; 0 and 1 share of Series D Preferred Stock authorized at June 30, 2026 and December 31, 2025, respectively; 0 and 1 share of Series D Preferred Stock issued and outstanding at June 30, 2026 and December 31, 2025, respectively
— — 
Series E Preferred Stock—$0.001 par value; 0 and 1 share of Series E Preferred Stock authorized at June 30, 2026 and December 31, 2025, respectively; 0 and 1 share of Series E Preferred Stock issued and outstanding at June 30, 2026 and December 31, 2025, respectively
— — 
Stockholders’ equity:
Common stock—$0.001 par value; 200,000,000 shares authorized at June 30, 2026 and December 31, 2025; 52,900,692 and 18,512,757 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively
53 18 
Series C Preferred Stock—$0.001 par value; 4,085 and 34,326 shares of Series C Preferred Stock authorized at June 30, 2026 and December 31, 2025, respectively; 4,085 and 18,792 shares of Series C Preferred Stock issued and outstanding at June 30, 2026 and December 31, 2025, respectively
— — 
Series C-1 Preferred Stock—$0.001 par value; 4,295 and 0 shares of Series C-1 Preferred Stock authorized at June 30, 2026 and December 31, 2025, respectively; 4,295 and 0 shares of Series C-1 Preferred Stock issued and outstanding at June 30, 2026 and December 31, 2025, respectively
— — 
Additional paid-in capital953,700 531,485 
Accumulated other comprehensive (loss) income(583)68 
Accumulated deficit(504,510)(448,522)
Total stockholders’ equity448,660 83,049 
Total liabilities, mezzanine equity and stockholders’ equity$490,783 $116,458 
The consolidated balance sheets as of June 30, 2026 and December 31, 2025 have been derived from the reviewed and audited financial statements, respectively, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements.

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Consolidated Statements of Operations
(In thousands, except per share data)
Three Months EndedSix Months Ended
June 30,June 30,
2026202520262025
Operating expenses:
Research and development23,418 14,074 37,466 23,195 
General and administrative8,099 5,242 14,953 10,789 
Total operating expenses31,517 19,316 52,419 33,984 
Loss from operations(31,517)(19,316)(52,419)(33,984)
Other (expense) income:
Change in fair value of derivative liability(1,010)(2,530)(530)(2,150)
Change in fair value of contingent consideration(6,574)— (6,574)— 
Interest income, net2,761 1,097 3,564 2,244 
Total other (expense) income, net(4,823)(1,433)(3,540)94 
Loss before taxes(36,340)(20,749)(55,959)(33,890)
Income tax expense18 16 29 24 
Net loss$(36,358)$(20,765)$(55,988)$(33,914)
Net loss per share of common stock, basic and diluted $(0.83)$(1.92)$(1.75)$(3.18)
Weighted average common shares outstanding43,602,044 10,829,760 31,919,388 10,673,200 
Comprehensive loss:
Net loss$(36,358)$(20,765)$(55,988)$(33,914)
Other comprehensive loss:
Unrealized loss on investments, net(577)(34)(651)(34)
Comprehensive loss$(36,935)$(20,799)$(56,639)$(33,948)

The unaudited consolidated statements of operations for the three and six months ended June 30, 2026 and 2025 have been derived from the reviewed financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.


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About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases. Avalo is advancing its lead anti-IL-1β monoclonal antibody (mAb) drug candidate, abdakibart, into a phase 3 registrational program in hidradenitis suppurativa (HS), a chronic inflammatory skin condition that affects an estimated 1-4% of the population globally. Avalo is pursuing additional development opportunities in IL-1β driven indications. Avalo is also developing AVTX-010, a long-acting next-generation anti-IL-1β mAb. For more information about Avalo, please visit www.avalotx.com.

About Abdakibart

Abdakibart is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a pro-inflammatory cytokine that plays a central role in the pathogenesis of a wide range of human diseases. It activates immune cells that generate proinflammatory cytokines, including IL-6, TNF-α, and IL-17. Dysregulated IL-1β signaling is a major driver of inflammation, contributing to the progression of autoimmune disorders. IL-1β inhibition has proven effective in multiple immune-mediated inflammatory diseases.

About AVTX-010

AVTX-010 is an Fc-engineered, long-acting anti-IL-1β monoclonal antibody designed to extend half-life while preserving the pharmacology and specificity of abdakibart.

Forward-Looking Statements

This press release includes forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond our control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to our plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: therapeutic potential, clinical benefits and safety profiles of abdakibart (AVTX-009); plans to advance abdakibart into a registrational phase 3 program; plans to advance AVTX-010 into clinical trials; the timing of an IND submission for AVTX-010 in the first half of 2027; our financial condition and expected cash runway into 2029; expectations regarding timing, success and data announcements of ongoing preclinical studies and clinical trials; drug development costs, reliance on investigators and enrollment of patients in clinical trials; and our plans to develop and commercialize our current and any future product candidates and the implementation of our business model and strategic plans for our business.

Any forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements including, without limitation, risks associated with: the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of our product candidates; the risk that the results of prior preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical studies and clinical trials, including those for abdakibart and AVTX-010; the timing and outcome of any interactions with regulatory authorities; obtaining, maintaining and protecting our intellectual property; the availability of funding sufficient for our operating expenses and capital expenditure requirements, reliance on key personnel; regulatory risks; general economic and market risks and uncertainties, including those caused by the war in Ukraine and the Middle East; and those other risks detailed in our filings with the Securities and Exchange Commission, available at www.sec.gov. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. In addition, any forward-looking statements represent our view only as of today and should not be
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relied upon as representing its views as of any subsequent date. You should not rely upon forward-looking statements as predictions of future events and actual results or events could differ materially from the plans, intentions and expectations disclosed herein. Except as required by applicable law, we expressly disclaim any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For media and investor inquiries
Christopher Sullivan, CFO
Avalo Therapeutics, Inc.
ir@avalotx.com
410-803-6793

or

Meru Advisors
Lauren Glaser
lglaser@meruadvisors.com
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Source: View Original Filing on SEC EDGAR

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