Barinthus Bio Reports Full Year 2024 Financial Results and Updates on Corporate Developments
Strategic transformation ongoing, positioning the Company as a focused leader in immunology and inflammatory diseases
Highly differentiated, potentially curative immunotherapy for celiac disease (VTP-1000) in the clinic, with first data expected in third quarter of 2025
Proprietary SNAP-TI platform promoting antigen-specific immune tolerance is anticipated to drive multiple future pipeline and partnership opportunities
Strategic prioritization of resources expected to provide a cash runway into 2027
OXFORD, United Kingdom and GERMANTOWN, Md., March 20, 2025 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: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 year ended December 31, 2024 and provided an overview of the Company's business updates.
"We've entered 2025 with a refreshed strategic focus on immunological and inflammatory diseases. Following our restructuring, we are strongly positioned to advance our highly differentiated lead asset,VTP-1000, (and the underlying SNAP-TI platform) in patients with celiac disease. Through design innovations enabling greater targeting of disease antigens, intramuscular administration and potentially improved tolerability, VTP-1000 has promise to be a leading therapy for the approximate 80 million people worldwide with celiac disease. We look forward to reporting single-ascending dose Phase 1 data for this program in the third quarter of this year." said Bill Enright, Chief Executive Officer of Barinthus Bio. "VTP-1000 is based on our innovative SNAP-TI platform, which is differentiated based on its capacity to promote antigen-specific immune tolerance that specifically guides a patient's T cells to suppress unwanted inflammation and restore the natural state of immune non-responsiveness to healthy tissue without affecting immunity against cancer or infections. Given this mild and potentially curative approach to restoring balance to the immune system, we believe SNAP-TI is poised to drive multiple future pipeline and partnership opportunities for the company particularly for autoimmune diseases where broadly immunosuppressive drugs are not optimal."
"Turning to our development candidates designated for partnering, we reported highly encouraging results from two Phase 2 trials in our chronic hepatitis B ("CHB") program demonstrating that VTP-300 contributed to the achievement of undetectable HBsAg levels in eight participants, with two participants meeting functional cure criteria. Further Phase 2 data are anticipated in the second quarter of 2025, which are expected to strengthen VTP-300's market positioning as a component of a functional cure for CHB."
2024 Corporate MilestonesClinical developments
Celiac Disease (VTP-1000)
In April 2024, Barinthus Bio received clearance from the U.S. Food and Drug Administration and Australian regulatory authorities on an Investigational New Drug application to progress VTP-1000 in a first in human clinical trial in celiac disease.
In September 2024, Barinthus Bio initiated the first-in-human, Phase 1 AVALON trial for VTP-1000 in celiac disease. The AVALON trial aims to enroll 42 participants with celiac disease and will be conducted in two parts: the first part, a randomized double-blind placebo controlled single ascending dose, followed by the second part, a randomized double-blind placebo-controlled multiple ascending dose and incorporating a controlled gluten challenge to assess the impact of VTP-1000 administration on patients' exposure to gluten.
Chronic Hepatitis B (VTP-300)
In June 2024, Barinthus Bio presented interim data from the two Phase 2 trials of VTP-300, which achieved 19% undetectable HBsAg levels across both studies, indicating potential rates of functional cure. The majority of patients who were assessed reached very low levels of HBsAg and eligibility for nucleos(t)ide discontinuation.
In October 2024, the Company completed enrollment of the Phase 2b HBV003 clinical trial for VTP-300 in CHB.
In November 2024
Barinthus Bio reported positive updated interim data from the Phase 2b HBV003 clinical trial for VTP-300 showing that as of the data cut off, eight participants achieved complete HBsAg loss (defined as HBsAg levels below the lower limit of quantitation [<LLOQ, 0.05 IU/mL]) and two participants met the criteria for functional cure. Uniquely, two of the eight participants with HBsAg loss, including one of those who met functional cure criteria, developed anti-hepatitis B antibodies that they did not have before. The data were presented as an oral presentation at the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting® 2024.
Barinthus Bio announced interim data from the Phase 2a IM-PROVE II clinical trial in collaboration with Arbutus Biopharma Corporation ("Arbutus"). Participants received imdusiran followed by VTP-300 and low-dose nivolumab. Results indicated that Group C participants receiving nivolumab experienced increased rates of HBsAg loss at Week 48 (3/13) compared to Group A and B participants who received imdusiran and VTP-300 or placebo. These data were presented in a poster at AASLD.
Prostate Cancer (VTP-850)
In October 2024, Barinthus Bio completed enrollment of 22 participants in the Phase 1 PCA001 clinical trial of VTP-850 for prostate cancer.
High-Risk Human Papillomavirus (VTP-200)
In April 2024, Barinthus Bio announced topline results from the Phase 1b/2 APOLLO dose-ranging trial (also known as HPV001) of VTP-200 in women aged 25-55 with low-grade cervical lesions associated with persistent high-risk human papillomavirus (HPV) infection.
Corporate Updates
In May 2024, Barinthus Bio appointed physician, Leon Hooftman, M.D., as Chief Medical Officer, effective as of June 3, 2024.
In November 2024, Geoffrey Lynn, M.D., Ph.D. was promoted to Chief Scientific Officer following the departure of Nadège Pelletier, Ph.D.
In January 2025, Barinthus Bio announced a strategic business refocus and restructuring to prioritize immunology and inflammation indications, including antigen-specific immune tolerance. As part of the restructuring, two executive leadership team members based in the U.K., the Chief Operating Officer, Graham Griffiths, and Chief Financial Officer, Gemma Brown, will leave the Company following a greater strategic focus on U.S. operations.
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 able to take advantage of its differentiated ability to achieve sustained HBsAg loss and functional cure in patients with low levels of HBsAg.
Upcoming MilestonesCeliac 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.
Chronic Hepatitis B (VTP-300):
Topline results from the Phase 2b HBV003 clinical trial evaluating additional dosing of VTP-300 and low-dose nivolumab timing in people with chronic hepatitis B infection are expected in the second quarter of 2025.
Topline results from the Phase 2a IM-PROVE II clinical trial evaluating VTP-300, low-dose nivolumab and Arbutus' imdusiran in people with chronic hepatitis B infection are expected in the second quarter 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 (i.e., biochemical recurrence) are expected in the second quarter of 2025.
2024 Financial Highlights
Cash: As of December 31, 2024, cash, cash equivalents and restricted cash was $112.4 million, compared to $142.1 million as of December 31, 2023. The net cash used in operating activities was $28.9 million, primarily resulting from development of our pipeline and ongoing clinical trials, offset by revenue of $15.0 million. Based on current research and development plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements into 2027.
Revenue: Revenue was $15.0 million in 2024 compared to $0.8 million in 2023 and was comprised of the Company's share of royalties received by Oxford University Innovation as a result of commercial sales of Vaxzevria® by AstraZeneca. There is no expectation of additional payments.
Research and Development Expenses: Research and development expenses were $42.2 million in 2024 compared to $44.9 million in 2023, with the decrease mainly attributable to a reduction in expenses from VTP-200 (HPV) which completed in the first quarter of 2024 and VTP-850 (prostate cancer) which completed enrollment in the third quarter of 2024, partially offset by an increase in spending on earlier stage programs in tolerance indications. The year-on-year R&D expense per program is outlined in the following table. It is anticipated that research and development expenses related to legacy programs in infectious disease and oncology will reduce going forward, as the ongoing trials complete.
Period ended
Twelve monthsendedDecember 31,2024
Twelve monthsendedDecember 31,2023
Change
$
000
$
000
$
000
Direct research and development expenses by program:
VTP-1000 Celiac1
$
5,486
$
8,420
$
(2,934
)
VTP-300 HBV
10,474
11,276
(802
)
VTP-850 Prostate cancer
1,429
2,726
(1,297
)
VTP-200 HPV
2,009
4,950
(2,941
)
VTP-600 NSCLC2
473
597
(124
)
VTP-500 MERS3
610
—
610
Other and earlier stage programs4
3,228
1,787
1,441
Total direct research and development expenses
$
23,709
$
29,756
$
(6,047
)
Indirect research and development expenses:
Personnel-related (including share-based compensation)
15,867
12,702
3,165
Facility related
1,249
1,339
(90
)
Other indirect costs
1,411
1,077
334
Total indirect research and development expenses
18,527
15,118
