-- 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 of December 31, 2025 expected to provide runway into 2028
WAYNE, Pa., March 23, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) ("Avalo"), a clinical stage biotechnology company fully dedicated to developing IL-1<BETA>-based treatments for immune-mediated inflammatory diseases, today announced business updates and year-end financial results for 2025.
"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. Garry Neil, Chief Executive Officer. "We look forward to sharing the results which have the potential to demonstrate abdakibart's (AVTX-009) high affinity inhibition of IL-1<BETA> and positive impact on addressing the large unmet need of patients living with hidradenitis suppurativa."
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
of December 31, 2025. Net cash used in operating activities was $51.5
million for the year ended December 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 ended
December 31, 2025, an increase of $25.6 million from the year ended
December 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 ended
December 31, 2025, an increase of $5.7 million from the year ended
December 31, 2024, primarily driven by stock-based compensation expense
and headcount additions.
-- Net loss was $78.3 million for the year ended December 31, 2025, as
compared to net loss of $35.1 million for the year ended December 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 the March 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-ended
December 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 ended December 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)
December 31,
------------------------
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
Goodwill 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 December 31, 2025
and December 31, 2024; 1 share of
Series D Preferred Stock issued and
outstanding at December 31, 2025 and
2024 -- --
Series E Preferred Stock--$0.001 par
value; 1 share of Series E Preferred
Stock authorized at December 31, 2025
and December 31, 2024; 1 share of
Series E Preferred Stock issued and
outstanding at December 31, 2025 and
December 31, 2024 -- --
Stockholders' equity:
Common stock--$0.001 par value;
200,000,000 shares authorized at
December 31, 2025 and December 31,
2024; 18,512,757 and 10,471,934 shares
issued and outstanding at December 31,
2025 and December 31, 2024,
respectively 18 10
Series C Preferred Stock--$0.001 par
value; 34,326 shares of Series C
Preferred Stock authorized at December
31, 2025 and December 31, 2024, 18,792
and 24,896 shares of Series C Preferred
Stock issued and outstanding at
December 31, 2025 and December 31,
2024, respectively -- --
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 December 31, 2025 and 2024 have been derived from the audited financial statements, 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)
Year Ended December 31,
-----------------------------------------
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)
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