- Topline data expected from Phase 2 LOTUS trial of abdakibart (AVTX-009) for the treatment of hidradenitis suppurativa in the second quarter of 2026
- Cash, cash equivalents and short-term investments of approximately
$98 million as ofDecember 31, 2025 expected to provide runway into 2028
“2025 was a year of disciplined execution focused on the LOTUS trial, and we are thrilled to be approaching a transformational milestone with our topline data release expected in the second quarter of 2026,” said Dr.
Upcoming Anticipated Milestone:
- Abdakibart (AVTX-009) Phase 2 LOTUS trial: The global study which includes approximately 250 adults with hidradenitis suppurativa (HS) is designed to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo.
- Topline data expected in the second quarter of 2026.
2025 Financial Update:
- Cash, cash equivalents and short-term investments were
$98.3 million as ofDecember 31, 2025 . Net cash used in operating activities was$51.5 million for the year endedDecember 31, 2025 . Avalo’s current cash, cash equivalents and short-term investments are expected to fund operations into 2028. - Research and development expenses were
$50.1 million for the year endedDecember 31, 2025 , an increase of$25.6 million from the year endedDecember 31, 2024 , driven by costs related to and supporting the Phase 2 LOTUS trial. - General and administrative expenses were
$22.9 million for the year endedDecember 31, 2025 , an increase of$5.7 million from the year endedDecember 31, 2024 , primarily driven by stock-based compensation expense and headcount additions. - Net loss was
$78.3 million for the year endedDecember 31, 2025 , as compared to net loss of$35.1 million for the year endedDecember 31, 2024 . The difference was driven by$38.7 million change in other (expenses) income from the prior period primarily related to the warrants issued in theMarch 2024 private placement, all of which were fully exercised in 2024. Operating expenses increased by$4.0 million mainly due to a$25.6 million increase in research and development expenses, as discussed above, and$5.7 million increase in general and administrative expenses, as discussed above, largely offset by$27.6 million of in-process research and development recognized in 2024 that did not repeat. Basic and diluted net loss per share was$5.84 for the year-endedDecember 31, 2025 compared to basic net loss per share of$7.94 , based on 13,404,830 weighted average common shares outstanding and 4,426,149 weighted average basic common shares outstanding, respectively. Diluted net loss per share for the year endedDecember 31, 2024 was$20.91 , based on 7,496,389 weighted average diluted common shares outstanding.
Consolidated Balance Sheets
(In thousands, except share and per share data)
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 15,858 | $ | 134,546 | ||||
| Short-term investments | 82,478 | — | ||||||
| Prepaid expenses and other current assets | 6,913 | 4,325 | ||||||
| Restricted cash, current portion | 37 | 19 | ||||||
| Total current assets | 105,286 | 138,890 | ||||||
| Property and equipment, net | 460 | 1,209 | ||||||
| 10,502 | 10,502 | |||||||
| Restricted cash, net of current portion | 210 | 131 | ||||||
| Total assets | $ | 116,458 | $ | 150,732 | ||||
| Liabilities, mezzanine equity and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 137 | $ | 283 | ||||
| Accrued expenses and other current liabilities | 12,803 | 6,317 | ||||||
| Derivative liability, current | — | 360 | ||||||
| Total current liabilities | 12,940 | 6,960 | ||||||
| Royalty obligation | 2,000 | 2,000 | ||||||
| Deferred tax liability, net | 434 | 270 | ||||||
| Derivative liability, non-current | 18,000 | 8,120 | ||||||
| Other long-term liabilities | 35 | 350 | ||||||
| Total liabilities | 33,409 | 17,700 | ||||||
| Mezzanine equity: | ||||||||
| Series D Preferred Stock—$0.001 par value; 1 share of Series D Preferred Stock authorized at | — | — | ||||||
| Series E Preferred Stock—$0.001 par value; 1 share of Series E Preferred Stock authorized at | — | — | ||||||
| Stockholders’ equity: | ||||||||
| Common stock—$0.001 par value; 200,000,000 shares authorized at | 18 | 10 | ||||||
| Series C Preferred Stock—$0.001 par value; 34,326 shares of Series C Preferred Stock authorized at | — | — | ||||||
| Additional paid-in capital | 531,485 | 503,285 | ||||||
| Accumulated other comprehensive income | 68 | — | ||||||
| Accumulated deficit | (448,522 | ) | (370,263 | ) | ||||
| Total stockholders’ equity | 83,049 | 133,032 | ||||||
| Total liabilities, mezzanine equity and stockholders’ equity | $ | 116,458 | $ | 150,732 | ||||
The consolidated balance sheets as of
Consolidated Statements of Operations
(In thousands, except per share data)
| Year Ended | |||||||||||
| 2025 | 2024 | ||||||||||
| Revenues: | |||||||||||
| Product revenue, net | $ | 59 | $ | 441 | |||||||
| Total revenues, net | 59 | 441 | |||||||||
| Operating expenses: | |||||||||||
| Cost of product sales | — | (366 | ) | ||||||||
| Research and development | 50,084 | 24,437 | |||||||||
| Acquired in-process research and development | — | 27,641 | |||||||||
| General and administrative | 22,900 | 17,241 | |||||||||
| Total operating expenses | 72,984 | 68,953 | |||||||||
| Loss from operations | (72,925 | ) | (68,512 | ) | |||||||
| Other (expense) income: | |||||||||||
| Change in fair value of derivative liability | (9,520 | ) | (2,930 | ) | |||||||
| Interest income, net | 4,351 | 3,312 | |||||||||
| Excess of initial warrant fair value over private placement proceeds | — | (79,276 | ) | ||||||||
| Change in fair value of warrant liability | — | 121,611 | |||||||||
| Private placement transaction costs | — | (9,220 | ) | ||||||||
| Total other (expense) income, net | (5,169 | ) | 33,497 | ||||||||
| Loss before income taxes | (78,094 | ) | (35,015 | ) | |||||||
| Income tax expense | 165 | 114 | |||||||||
| Net loss | $ | (78,259 | ) | $ | (35,129 | ) | |||||
| Net loss per share of common stock - basic | $ | (5.84 | ) | $ | (7.94 | ) | |||||
| Net loss per share of common stock - diluted | $ | (5.84 | ) | $ | (20.91 | ) | |||||
| Weighted average common shares outstanding - basic | 13,404,830 | 4,426,149 | |||||||||
| Weighted average common shares outstanding - diluted | 13,404,830 | 7,496,389 | |||||||||
The consolidated statements of operations for the year ended
About
About Abdakibart (AVTX-009)
Abdakibart (AVTX-009) is a humanized monoclonal antibody (IgG4) that binds to interleukin-1ß (IL-1ß) with high affinity and neutralizes its activity. IL-1ß is a pro-inflammatory cytokine that plays a central role in the pathogenesis of a wide range of human diseases.1 It activates immune cells that generate proinflammatory cytokines, including IL-6, TNF-a, and IL-17. Dysregulated IL-1ß signaling is a major driver of inflammation, contributing to the progression of autoimmune disorders. IL-1ß inhibition has proven effective in multiple immune-mediated inflammatory diseases.1-3
About the LOTUS Trial
The LOTUS trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two abdakibart (AVTX-009) dose regimens to evaluate the efficacy, safety and tolerability of abdakibart (AVTX-009) in approximately 250 adults with moderate to severe hidradenitis suppurativa. Subjects were randomized (1:1:1) to receive either one of two dosing regimens of abdakibart (AVTX-009) or placebo during a 16-week treatment phase. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include but are not limited to: the proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: International HS Severity Score System (IHS4), draining fistula count, abscess and inflammatory nodule (AN) count, and patients achieving at least a 30% reduction on a numerical rating scale in Patient's Global Assessment of
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic, progressive, often debilitating inflammatory skin disease that causes painful nodules, abscesses, and tunnels to form under the skin.4-6,8 Areas commonly affected by HS include the nape of the neck, breasts, chest, armpits, abdomen, buttocks and anus, groin and genitals, and inner thighs.7 If not adequately and promptly treated, the chronic inflammation characteristic of HS may progress to tissue destruction and permanent scarring.4-6,9 HS typically first presents in late adolescence or early adulthood and is estimated to affect 0.7–1.2% of the
References:1Dinarello CA. Immunol Rev. 2018;281(1):8-27. 2Kany S et al. Int J Mol Sci. 2019;20(23):6008. 3
Forward-Looking Statements
This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Forward-looking statements are statements that are not historical facts. These statements are based on various assumptions, whether or not identified in this press release, and are the current expectations of Avalo’s management and are not predictions of actual performance. 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 Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s 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) that predict or indicate future trends or events. These forward-looking statements include, without limitation, statements regarding Avalo’s expectations regarding its growth, strategy, progress and timing of its clinical trials for abdakibart (AVTX-009) and any other future product candidates, the design and conduct of the Phase 2 LOTUS trial, including expected timelines for clinical data readouts, and Avalo’s beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, including statements regarding anticipated operating expenses, Avalo’s cash runway and sufficiency of its cash and cash equivalents to fund its operations. These forward-looking statements are subject to a number of risks and uncertainties, such as: changes in domestic and foreign business, market, financial, political, and legal conditions;, or by discussions of future matters such as: drug development costs, timing of trials and trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials; reliance on key personnel; regulatory risks; general economic and market risks and uncertainties; and those other risks detailed in Avalo’s filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ from those set forth in the forward-looking statements. In addition, forward-looking statements reflect Avalo’s expectations, plans, or forecasts of future events and views as of the date of this press release and are qualified in their entirety by reference to the cautionary statements herein. Avalo anticipates that subsequent events and developments will cause Avalo’s assessments to change. These forward-looking statements should not be relied upon as any guarantee, assurance, prediction or definitive statement of fact or probability or as representing Avalo’s assessments as of any date subsequent to the date of this press release. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.
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