Barinthus Bio Reports First Quarter 2025 Financial Results and Updates on Corporate Developments
-- Highly differentiated immunotherapy for celiac disease (VTP-1000) in the
clinic, with Phase 1 single ascending dose readout from AVALON expected
in the third quarter of 2025;
-- Initiation of VTP-1000 multiple ascending dose expected in the second
half of 2025;
-- Encouraging results from HBV003 and IM-PROVE II presented at EASL,
supporting ongoing partnering efforts;
-- Available resources expected to provide a cash runway into 2027.
OXFORD, United Kingdom and GERMANTOWN, Md., May 07, 2025 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc $(BRNS)$ ("Barinthus Bio," or the "Company"), an immunology and inflammation ("I&I") company focused on developing therapies that promote immune tolerance with curative potential, today announced its financial results for the quarter ended March 31, 2025 and provided an overview of the Company's corporate developments.
"2025 has started with a strategic focus on immunological and inflammatory diseases, which includes directing our resources to our highly differentiated lead asset,VTP-1000, using the SNAP-TI platform, being tested in patients with celiac disease. Looking ahead, we remain on track to announce Phase 1 single ascending dose data for the celiac program using VTP-1000 in the third quarter of 2025, and will be initiating the multiple ascending dose part of the Phase 1 clinical trial in the second half of 2025, where we are incorporating a gluten challenge as part of our initial clinical evaluation of efficacy," said Bill Enright, Chief Executive Officer of Barinthus Bio. "Today, we announced multiple data milestones from our viral vector pipeline, including encouraging primary endpoint analyses from the two Phase 2 trials in chronic hepatitis B ("CHB") which we believe strengthen VTP-300's market positioning as a component of a potential functional cure for CHB."
First Quarter 2025 and Recent Corporate Developments
Clinical Developments
Data from two Phase 2 clinical trials of VTP-300 will be showcased in poster presentations at the European Association for the Study of the Liver ("EASL") Congress 2025, taking place May 7-10, 2025, in Amsterdam, the Netherlands. The presentations include the six-month primary analysis of the Phase 2b clinical trial (HBV003), as well as end-of-study data from the Phase 2a clinical trial (IM-PROVE II, AB-729-202) in partnership with Arbutus Biopharma, both in people with CHB receiving ongoing standard of care nucleos(t)ide analogue ("NUC") therapy.
HBV003 data: VTP-300 and Low-dose Nivolumab
The HBV003 study is evaluating the safety, immunogenicity and disease modifying activity of three different dosing regimens of VTP-300 in combination with low-dose nivolumab ("LDN"), an anti-PD-1 monoclonal antibody. The primary analysis showed;
-- In CHB participants with hepatitis B surface antigen ("HBsAg") levels of
<200 IU/mL, meaningful reductions in HBsAg (>1 log decline) occurred soon
after dosing on Day 29 in all treatment groups and were maintained to Day
169.
-- In the two best treatment arms HBsAg declines of >=1 log at Day 169 were
observed in 33% (15/45) of participants with HBsAg <=200 IU/mL at
baseline, and 22% (10/45) of participants achieved HBsAg loss at any
timepoint.
-- 71% (48/68) of participants met the criteria for discontinuation of NUC
therapy at day 169; and although NUC discontinuation was optional; two
participants who did discontinue NUCs achieved functional cure and one
seroconverted to HBsAb positivity.
-- Treatment with VTP-300 in combination with LDN was generally
well-tolerated, with no serious adverse events reported.
The primary analysis confirms observations from previous interim data, which indicated that stronger responses occurred in participants treated with the combination of VTP-300 and LDN (Groups 1 and 2).
IM-PROVE II data: imdusiran and VTP-300
The IM-PROVE II study is evaluating the combination of imdusiran ("IDR"), Arbutus' RNAi therapeutic, followed by Barinthus Bio's T-cell stimulating immunotherapeutic, VTP-300, with or without LDN. The end of study data showed:
-- 25% (2/8) of participants with starting baseline HBsAg levels less than
1000 IU/mL receiving the combination of IDR, VTP-300 and LDN achieved
functional cure.
-- 3 of 13 participants (23%) receiving IDR+VTP-300+LDN had undetectable
HBsAg levels at week 48; all (3/3) of participants with HBsAg loss
seroconverted.
-- Treatment with IDR and VTP-300 was generally well-tolerated, with no
serious adverse events or treatment discontinuations reported.
Corporate Updates
-- In January 2025, Barinthus Bio announced a strategic business refocus and
restructuring to prioritize immunology and inflammation indications,
including antigen-specific immune tolerance. Barinthus Bio will not
invest in VTP-300 for chronic hepatitis B beyond the completion of the
ongoing Phase 2b HBV003 clinical trial and will seek potential partners
to be able to take advantage of its differentiated ability to achieve
sustained HBsAg loss and functional cure in patients with low levels of
HBsAg. Partners are also being sought for the other assets that are based
upon the viral vector platforms.
Upcoming Milestones
Celiac Disease (VTP-1000):
-- Single ascending dose data from the Phase 1 AVALON clinical trial
evaluating the safety, tolerability, pharmacokinetics and
pharmacodynamics of VTP-1000 in adults with celiac disease expected in
the third quarter of 2025.
-- Initiation of the multiple ascending dose portion of the Phase 1 AVALON
clinical trial is expected in the second half of 2025.
Prostate Cancer (VTP-850):
-- Topline results from the Phase 1 PCA001 clinical trial evaluating safety
and efficacy of VTP-850 in men with rising prostate-specific antigen
after definitive local therapy for prostate cancer were received and
analysis is ongoing. Data will be used to support partnering efforts for
VTP-850.
First Quarter 2025 Financial Highlights
-- Cash: As of March 31, 2025, cash, cash equivalents and restricted cash
was $100.6 million, compared to $112.4 million as of December 31, 2024.
The $11.8 million decrease is a result of the net cash used in operating
activities of $14.9 million for the development of our pipeline and
ongoing clinical trials, offset by a $3.1 million gain on foreign
exchange on cash, cash equivalents and restricted cash. Based on current
research and development plans, the Company expects its available
resources to fund its operating expenses and capital expenditure
requirements into 2027.
-- Research and Development Expenses: Research and development expenses were
$8.3 million for the three months ended March 31, 2025 compared to $11.1
million for the three months ended March 31, 2024, with the decrease
attributable to the stage of clinical development of the pipeline assets,
a reduction in preclinical activity and a reduction in workforce when
compared to the prior year. The year-on-year research and development
expenses per program are outlined in the following table. It is
anticipated that research and development expenses related to the legacy
programs in infectious disease and oncology will reduce going forward, as
the ongoing clinical trials complete, and that research and development
expenses related to autoimmune programs will continue or increase, as the
clinical development continues.
Three months Three months
ended March ended March
31, 2025 31, 2024 Change
-------------- -------------- ----------
$000 $000 $000
-------------- -------------- -------
Direct research and
development expenses by
program:
VTP-1000 Celiac $ 982 $ 1,374 $ (392)
VTP-300 HBV 1,350 1,913 (563)
Other clinical
programs(1) 741 1,767 (1,026)
Other pre-clinical
programs 419 784 (365)
--- --------- --- --------- ------
Total direct research and
development expenses 3,492 5,838 (2,346)
Indirect research and
development expenses:
Personnel-related
(including share-based
compensation)(2) 3,944 4,335 (391)
Facility related 335 390 (55)
Other indirect costs 519 562 (43)
--- --------- --- --------- ------
Total indirect research
and development expenses 4,798 5,287 (489)
--- --------- --- --------- ------
Total research and
development expense $ 8,290 $ 11,125 $(2,835)
=== ========= === ========= ======
(1) This includes expenses relating to the infectious disease and oncology programs; VTP-850 Prostate cancer, VTP-200 HPV, VTP-600 NSCLC (the Phase 1/2a trial is sponsored by Cancer Research UK) and VTP-500 MERS (funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations ("CEPI"). Expenses relating to these programs were previously presented separately, but are now aggregated for the prior period comparative.
(2) This includes $0.07 million and $0.14 million for the three months ended March 31, 2025 and 2024, respectively, of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI.
-- General and Administrative Expenses: General and administrative expenses
were $12.6 million in the first quarter of 2025, compared to $6.0 million
in 2024. The increase of $6.6 million relates primarily to a loss of $4.4
million on foreign exchange in 2025, compared to a gain of $1.2 million
in 2024 due to fluctuations between the pound sterling and the US dollar
during the year. The remaining increase is attributable to an increase in
depreciation of U.K. assets as a result of the expected closure of the
U.K. site, and an increase in personnel costs as a result of the
workforce reduction.
-- Net Loss: For the first quarter of 2025, the Company generated a net loss
attributable to its shareholders of $19.6 million, or $(0.49) per share
on both basic and fully diluted bases, compared to a net loss
attributable to its shareholders of $15.5 million, or $(0.40) per share
on both basic and fully diluted bases for the first quarter of 2024.
About Barinthus Bio
Barinthus Biotherapeutics (NASDAQ: BRNS) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic candidates for treating autoimmune and inflammatory diseases. Our guiding principle at the heart of Barinthus Bio is to help patients and their families by developing truly transformational and highly disease-specific immunotherapies that are potentially curative. Barinthus Bio's pipeline for I&I indications is enabled by our proprietary and highly differentiated platform for promoting immune tolerance, SNAP-TI, that is designed to guide a patient's T cells to a specific location to reduce inflammation and restore the natural state of immune non-responsiveness to healthy tissue. Our lead candidate, VTP-1000, is designed to restore immune non-responsiveness to gluten in patients with celiac disease and is currently in a Phase 1 clinical trial. Barinthus Bio's differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with autoimmune and inflammatory diseases. For more information, visit www.barinthusbio.com.
Forward Looking Statements
This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words "may," "will," "plan," "forward," "encouraging, " "believe," "potential," "expect," and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding our future expectations, plans and prospects, including our product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, the timing for initiation of any clinical trials, our anticipated regulatory filings and approvals, our cash runway and cash burn, our ability to develop and advance our current and future product candidates and programs, our ability to establish and maintain collaborations or strategic relationships and the terms and timing of the restructuring and related activities. Any forward-looking statements in this press release are based on our management's current expectations and beliefs and are subject to numerous 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 contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of our clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, our ability to execute on our strategy, regulatory developments, the risk that we may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, our ability to fund our operations and access capital, our cash runway, including the risk that our estimate of our cash runway may be incorrect, global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Israel and Gaza, tariffs imposed by the U.S. and other countries and other risks identified in our filings with the Securities and Exchange Commission (the "SEC"), including our most recent annual report on Form 10-K and subsequent filings we may make with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We expressly disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE
AMOUNTS)
(UNAUDITED)
March 31, December 31,
2025 2024
---------- --------------
ASSETS
Cash and cash equivalents $ 99,118 $ 110,662
Restricted cash 1,461 1,738
Research and development incentives
receivable 2,997 7,139
Prepaid expenses and other current
assets 6,306 6,203
-------- ---------
Total current assets 109,882 125,742
Property and equipment, net 6,201 7,373
Intangible assets, net 21,156 21,947
Right of use assets, net 3,855 4,384
Other assets 902 881
-------- ---------
Total assets $ 141,996 $ 160,327
======== =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable 1,357 2,474
Accrued expenses and other current
liabilities 7,198 9,525
Deferred income 1,461 1,738
Operating lease liability - current 1,960 1,920
Total current liabilities 11,976 15,657
-------- ---------
Non-current liabilities:
Operating lease liability -
non-current 9,959 10,087
Contingent consideration 2,652 2,650
Other non-current liabilities 1,400 1,360
Deferred tax liability, net 416 438
-------- ---------
Total liabilities $ 26,403 $ 30,192
-------- ---------
Commitments and contingencies (Note 15)
Stockholders' equity:
Ordinary shares, GBP0.000025 nominal
value; 40,339,395 shares authorized,
issued and outstanding (December 31,
2024: authorized, issued and
outstanding: 40,234,663) 1 1
Deferred A shares, GBP1 nominal
value; 63,443 shares authorized,
issued and outstanding (December 31,
2024: authorized, issued and
outstanding: 63,443) 86 86
Additional paid-in capital 393,944 393,474
Accumulated deficit (257,312) (237,664)
Accumulated other comprehensive loss
-- foreign currency translation
adjustments (21,225) (25,868)
-------- ---------
Total stockholders' equity
attributable to Barinthus
Biotherapeutics plc shareholders 115,494 130,029
Noncontrolling interest 99 106
-------- ---------
Total stockholders' equity $ 115,593 $ 130,135
-------- ---------
Total liabilities and stockholders'
equity $ 141,996 $ 160,327
======== =========
BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE
AMOUNTS)
(UNAUDITED)
Three months ended
------------------------------------
March 31, 2025 March 31, 2024
---------------- ------------------
Operating expenses
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