On May 7, 2025 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, reported its financial results for the quarter ended March 31, 2025 and provided an overview of the Company’s corporate developments (Press release, Barinthus Biotherapeutics, MAY 7, 2025, View Source [SID1234652633]).
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"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 ended March 31, 2025 Three months ended March 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 programs1
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.