STOCK TITAN

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

(Neutral)
Tags

Avalo Therapeutics (Nasdaq: AVTX) reported second quarter 2026 results and business updates, highlighting progress in its IL-1β-focused pipeline. The company plans to initiate a registrational Phase 3 program for abdakibart in hidradenitis suppurativa (HS) in the first half of 2027 and expects to submit an IND for AVTX-010, a long-acting next-generation anti-IL-1β antibody, in the same period.

Cash, cash equivalents and investments totaled $472.2 million as of June 30, 2026, which Avalo expects will fund operations into 2029. Q2 2026 research and development expenses were $23.4 million and general and administrative expenses were $8.1 million, leading to a net loss of $36.4 million or $0.83 per share. The company was added to the Russell 2000 and Russell 3000 Indexes and appointed Ron Philip to its Board of Directors.

Loading...
Loading translation...

Positive

  • Cash, cash equivalents and investments $472.2M as of June 30, 2026; runway into 2029
  • Q2 2026 R&D expense $23.4M, including recognition of a $10.0M development milestone for abdakibart
  • Planned Phase 3 program for abdakibart in hidradenitis suppurativa in 1H 2027
  • AVTX-010 IND submission targeted for 1H 2027, expanding IL-1β pipeline
  • Added to Russell 2000 and Russell 3000 indexes during FTSE Russell annual reconstitution

Negative

  • Net loss Q2 2026 $36.4M, up from $20.8M in Q2 2025
  • Total operating expenses Q2 2026 $31.5M vs $19.3M in Q2 2025
  • R&D expenses increased $9.3M YoY in Q2 2026 to $23.4M
  • G&A expenses increased $2.9M YoY in Q2 2026 to $8.1M
  • Fair value adjustments drove a $6.6M increase in contingent consideration expense in 2026

Market Context

AVTX's short positioning was moderate, while insiders were net sellers. This report's cash and spend...
Analysis

AVTX's short positioning was moderate, while insiders were net sellers. This report's cash and spending update adds operating context; the historical earnings average was -1.42%, with resale activity and clinical execution remaining watch items.

Key Figures

Phase 3 initiation: First half of 2027 IND submission: First half of 2027 Cash and investments: $472.2 million +5 more
8 metrics
Phase 3 initiation First half of 2027 Abdakibart in hidradenitis suppurativa
IND submission First half of 2027 AVTX-010 development program
Cash and investments $472.2 million As of June 30, 2026
Operating cash use $37.7 million Six months ended June 30, 2026
R&D expenses $23.4 million Q2 2026; increased $9.3 million from Q2 2025
G&A expenses $8.1 million Q2 2026; increased $2.9 million from Q2 2025
Net loss $36.4 million Q2 2026; increased $15.6 million from Q2 2025
Basic net loss per share $0.83 Q2 2026

Previous Earnings Reports

5 past events · Latest: May 13 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
May 13 Q1 earnings report Positive -0.5% Positive LOTUS data and financing contrasted with a 0.45% negative reaction.
Mar 23 FY2025 earnings Negative +0.6% Higher annual loss and expenses accompanied a 0.60% positive reaction.
Nov 06 Q3 earnings report Negative -6.3% Quarterly loss and trial updates were followed by a 6.26% decline.
Aug 07 Q2 earnings report Positive +0.5% Trial progress and cash resources accompanied a 0.48% positive reaction.
May 12 Q1 earnings report Negative -1.5% Quarterly loss and rising expenses accompanied a 1.48% decline.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Tag-specific earnings reactions were mixed, with an average move of -1.42% across the five prior earnings events.

Key Terms

hidradenitis suppurativa, anti-il-1β antibody, monoclonal antibody, investigational new drug (ind) application, +1 more
5 terms
hidradenitis suppurativa medical
"evaluating abdakibart in hidradenitis suppurativa (HS)"
A chronic skin disease marked by recurring, painful lumps and tunnels under the skin that often leak and leave scars; it behaves like a slow-burning, recurring infection in areas with many sweat glands. For investors, it matters because the condition has few consistently effective treatments and causes long-term healthcare use, making successful new drugs, devices, or diagnostics potentially high-value opportunities while also carrying clinical-trial, regulatory and reimbursement risks.
anti-il-1β antibody medical
"a long-acting next-generation anti-IL-1β antibody"
An anti‑IL‑1β antibody is a lab-made protein designed to stick to and neutralize interleukin‑1 beta, a naturally occurring immune signaling molecule that can drive inflammation. Think of it as a targeted sponge that soaks up a specific inflammatory alarm signal. As a drug class, it matters to investors because clinical trial results, regulatory decisions, manufacturing scale, and potential demand in inflammatory and cardiovascular diseases can materially affect a company’s pipeline value and commercial prospects.
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.
investigational new drug (ind) application regulatory
"submit an Investigational New Drug (IND) application"
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.
phase 3 registrational program clinical
"initiate a registrational Phase 3 program evaluating abdakibart"
A phase 3 registrational program is the late-stage set of clinical trials designed to generate the definitive safety and effectiveness data regulators require to decide on approving a drug or medical device; these are typically large, multi-site studies in the intended patient group. It matters to investors because passing this “final exam” is the main pathway to market authorization and revenue, while failure or delay can sharply reduce a product’s commercial value.

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
  • 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., Aug. 06, 2026 (GLOBE NEWSWIRE) -- 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.
  • 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.

Consolidated Balance Sheets
(In thousands, except share and per share data)
  June 30, 2026 December 31, 2025
  (unaudited)  
Assets    
Current assets:    
Cash and cash equivalents $85,382  $15,858 
Short-term investments  314,894   82,478 
Prepaid expenses and other current assets  7,607   6,913 
Restricted cash, current portion  49   37 
Total current assets  407,932   105,286 
Long-term investments  71,878    
Property and equipment, net  288   460 
Goodwill  10,502   10,502 
Restricted cash, net of current portion  183   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 liabilities  17,783   12,803 
Total current liabilities  21,130   12,940 
Royalty obligation  2,000   2,000 
Deferred tax liability, net  463   434 
Derivative liability, non-current  18,530   18,000 
Other long-term liabilities     35 
Total liabilities  42,123   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 capital  953,700   531,485 
Accumulated other comprehensive (loss) income  (583)  68 
Accumulated deficit  (504,510)  (448,522)
Total stockholders’ equity  448,660   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.

Consolidated Statements of Operations
(In thousands, except per share data)
  Three Months Ended Six Months Ended
  June 30, June 30,
   2026   2025   2026   2025 
Operating expenses:        
Research and development  23,418   14,074   37,466   23,195 
General and administrative  8,099   5,242   14,953   10,789 
Total operating expenses  31,517   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, net  2,761   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 expense  18   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 outstanding  43,602,044   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.

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 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


FAQ

How much cash does Avalo Therapeutics (AVTX) have as of June 30, 2026?

Avalo Therapeutics reported $472.2 million in cash, cash equivalents and investments as of June 30, 2026. According to Avalo Therapeutics, this capital is expected to fund operations into 2029, supporting its clinical programs in hidradenitis suppurativa and broader IL-1β pathway development.

What were Avalo Therapeutics (AVTX) Q2 2026 financial results and net loss per share?

Avalo Therapeutics recorded a Q2 2026 net loss of $36.4 million, or $0.83 per basic and diluted share. According to Avalo Therapeutics, this compares with a net loss of $20.8 million, or $1.92 per share, for the second quarter of 2025.

When will Avalo Therapeutics start the Phase 3 trial of abdakibart in hidradenitis suppurativa?

Avalo Therapeutics plans to initiate a registrational Phase 3 program for abdakibart in hidradenitis suppurativa in the first half of 2027. According to Avalo Therapeutics, abdakibart is its lead anti-IL-1β monoclonal antibody targeting immune-mediated inflammatory diseases, including HS.

What is AVTX-010 and when is Avalo Therapeutics (AVTX) planning its IND submission?

AVTX-010 is a long-acting, Fc-engineered anti-IL-1β monoclonal antibody designed to extend half-life while preserving abdakibart’s pharmacology. According to Avalo Therapeutics, the company expects to submit an Investigational New Drug (IND) application for AVTX-010 in the first half of 2027.

How did Avalo Therapeutics’ R&D and G&A expenses change in Q2 2026 versus Q2 2025?

In Q2 2026, research and development expenses were $23.4 million and general and administrative expenses were $8.1 million. According to Avalo Therapeutics, R&D increased by $9.3 million and G&A by $2.9 million year over year, partly due to a $10 million abdakibart milestone.

What index changes affected Avalo Therapeutics (NASDAQ: AVTX) in 2026?

Avalo Therapeutics was added to the Russell 2000 and Russell 3000 Indexes as part of FTSE Russell’s annual reconstitution. According to Avalo Therapeutics, this inclusion may increase visibility with institutional investors who track or benchmark against these equity indexes.

Who joined the Avalo Therapeutics (AVTX) Board of Directors in 2026?

Avalo Therapeutics appointed Ron Philip to its Board of Directors. According to Avalo Therapeutics, he brings strategic and commercial expertise, including experience in bringing novel therapies to market, supporting the company’s focus on IL-1β–targeted treatments for inflammatory diseases.