-- Proposed combination with Clywedog Therapeutics Inc. ("Clywedog") to create a differentiated company focusing on clinical metabolic and autoimmune pipeline assets and to build on the Company's base of high caliber institutional investors, expected to complete in the second quarter of 2026 -- Multiple ascending dose part of the Phase 1 AVALON trial of VTP-1000 in celiac disease patients is progressing; data expected in the second half of 2026
GERMANTOWN, Md., March 13, 2026 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc $(BRNS)$ ("Barinthus Bio," or the "Company"), today announced its financial results for the year ended December 31, 2025, and provided an overview of the Company's corporate developments. Barinthus Bio is an immunology and inflammation ("I&I") company focused on developing therapies that promote immune tolerance with curative potential.
"As we move into 2026, we are excited by the proposed combination of Barinthus Bio and Clywedog, which positions us for multiple near-term catalysts emerging from our differentiated and complimentary clinical portfolio." said Bill Enright, Chief Executive Officer of Barinthus Bio. "We finished 2025 reporting encouraging results from the single ascending dose portion of the Phase 1 AVALON clinical trial of VTP-1000 in celiac disease, and expect multiple ascending dose data in the second half of 2026. These upcoming results will help us confirm whether VTP-1000 has the potential to be disease-modifying by restoring balance to the immune system."
Corporate Milestones
-- In January 2025, Barinthus Bio announced a strategic business refocus and
restructuring to prioritize immunology and inflammation indications,
including antigen-specific immune tolerance and the development of
VTP-1000 in celiac disease. Infectious disease and oncology assets,
collectively referred to as "Barinthus legacy assets," which include
VTP-300 in chronic hepatitis B ("CHB") and VTP-850 in prostate cancer,
were deprioritized for direction operations, and will only be progressed
with a partner.
-- In May 2025, Barinthus Bio presented data from two Phase 2 clinical
trials of VTP-300 in CHB at the European Association for the Study of the
Liver ("EASL") Congress 2025 showing VTP-300 induced meaningful and
sustained reductions in hepatitis B surface antigen levels.
-- In September 2025, Barinthus Bio announced it had entered into a
definitive merger agreement to combine in an all-stock transaction with
Clywedog, a private company advancing breakthrough medicines in diabetes.
The newly combined company will advance a differentiated portfolio of
clinical-stage candidates targeting metabolic and autoimmune diseases,
with four clinical data milestones expected within 18 months of the
closing of the transaction.
-- In December 2025, Barinthus Bio announced that the single ascending dose
portion of the Phase 1 AVALON trial (NCT06310291) of VTP-1000 for the
treatment of celiac disease had been completed. A total of 18 patients
were enrolled in three placebo-controlled cohorts of ascending doses.
VTP-1000 was well tolerated at all dose levels with no treatment-related
serious adverse events. Pharmacodynamic analyses, including IL-2 response,
confirmed T cell recognition of VTP-1000 in celiac patients across
cohorts.
-- In February 2026, Barinthus Bio announced it had entered into an
amendment to the definitive merger agreement with Clywedog to update the
exchange ratio framework to provide additional flexibility in finalizing
the transaction terms and to revise certain minimum cash requirements to
reflect anticipated transaction timing. All other material terms remain
unchanged.
Upcoming Milestones
Celiac Disease (VTP-1000):
-- Data from the multiple ascending dose portion of the Phase 1 AVALON
clinical trial, which includes a gluten challenge following three doses
of test medication, is expected in the second half of 2026.
Corporate:
-- Barinthus Bio expects to complete the merger with Clywedog in the second
quarter of 2026. Upon the closing of the transaction, the combined
company will be renamed "Clywedog Therapeutics Holdings, Inc." and is
expected to trade on the NASDAQ under the new ticker symbol "CLYD." The
combined company's estimated cash runway is expected to extend through
2027, supported by existing cash and additional investments by OrbiMed
and TPAV, LLC, both existing shareholders in Clywedog, and new investors.
2025 Financial Highlights
-- Cash: As of December 31, 2025, cash, cash equivalents and restricted cash
were $71.9 million, compared to $112.4 million as of December 31, 2024.
The $40.5 million decrease was a result of the net cash used in operating
activities of which $48.0 million was used for the development of the
Company's pipeline and general corporate expenses, offset by a $7.0
million translational gain from the conversion of balances in pound
sterling denominated entities to the United States dollar reporting
currency and $0.4 million in proceeds from the sale of equipment in the
U.K. following the closure of the site. Based on standalone research and
development plans, the Company expects its available resources to fund
its operating expenses and capital expenditure requirements for at least
the next 12 months from the date of issuance of the financial statements.
-- Research and Development Expenses: Research and development expenses were
$25.6 million in 2025 compared to $42.2 million in 2024. The decrease was
primarily attributable to reduced activity in the Barinthus legacy asset
clinical programs and the reduction in workforce. The year-on-year
research and development expenses are outlined in the following table,
with the expense primarily attributable to the continued progression of
the Phase 1 AVALON clinical trial of VTP-1000 in celiac disease, and the
reduced activity on legacy assets in infectious disease and oncology. It
is anticipated that research and development expenses related to the
Barinthus legacy assets in infectious disease and oncology will continue
to decrease going forward as the clinical trials complete, and that
research and development expenses related to autoimmune program will
continue at current levels or increase, as the clinical development
continues.
Twelve months
ended Twelve months
December 31, ended December
2025 31, 2024 Change
------------- -------------- -----------
$000 $000 $000
------------- -------------- --------
Direct research and
development expenses by
program:
VTP-1000 Celiac $ 6,063 $ 5,486 $ 577
Barinthus legacy
assets(1) 8,531 18,223 (9,692)
--- -------- --- --------- -------
Total direct research and
development expenses 14,594 23,709 (9,115)
Indirect research and
development expenses:
Personnel-related
(including share-based
compensation) 8,413 15,867 (7,454)
Facility related 1,370 1,249 121
Other indirect costs 1,187 1,411 (224)
--- -------- --- --------- -------
Total indirect research
and development expenses 10,970 18,527 (7,557)
--- -------- --- --------- -------
Total research and
development expense $ 25,564 $ 42,236 $(16,672)
=== ======== === ========= =======
(1) In January 2025, we announced a strategic focus on developing a pipeline in I&I, and the deprioritization of our programs in infectious disease and oncology. The following programs were previously presented separately and have been grouped collectively as "Barinthus Legacy Assets" for both years presented: VTP-300 HBV, VTP-850 Prostate Cancer, VTP-200 HPV, VTP-600 NSCLC, VTP-500 MERS and other and earlier stage programs.
-- General and Administrative Expenses: General and administrative expenses
were $40.8 million in 2025, compared to $29.7 million in 2024. The
increase of $11.1 million related primarily to an increase in unrealized
losses on foreign exchange driven mainly by translation of United States
dollar balances in pound sterling denominated entities and an increase in
professional fees attributable to strategic activity, partially offset by
decreases in personnel-related expenses and other costs following the
strategic prioritization in the year.
-- Impairment of Intangible Assets: Impairment of intangible assets expense
was $4.7 million in 2025, compared to nil in 2024. The anticipated
valuation of the company, as implied by the definitive merger agreement
with Clywedog entered into in the year, was less than the carrying value
of the net assets and therefore resulted in an impairment of the
intangible assets in the third quarter of 2025.
-- Net Loss: For the financial year 2025, the Company generated a net loss
attributable to its shareholders of $66.5 million, or $(1.64) per share
on both basic and fully diluted bases, compared to a net loss
attributable to its shareholders of $61.1 million, or $(1.55) per share
on both basic and fully diluted bases for the financial year 2024.
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