Barinthus Bio Q2 2024 Corporate and Financial Update

OXFORD, United Kingdom, Aug. 08, 2024 - Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical firm, has provided an update on its company's advancements and released its financial outcomes for the second quarter of 2024.

Following positive VTP-300 Phase 2 data in hepatitis B virus (HBV), Barinthus Biotherapeutics has decided to prioritize its HBV and celiac disease programs. CEO Bill Enright announced that these programs offer the highest likelihood for success and significant opportunities in areas with considerable unmet patient needs. The company plans to commence its first human clinical trial of VTP-1000 for celiac disease in the third quarter, utilizing its innovative SNAP-TI platform. Celiac disease currently lacks FDA or EMA-approved treatments.

In June 2024, Barinthus announced updated data from two ongoing Phase 2 clinical trials in chronic hepatitis B (CHB). Data from these trials were presented at the European Association for the Study of the Liver (EASL) Congress 2024. The updates included interim results from both the Phase 2b clinical trial (HBV003) and the Phase 2a clinical trial (IM-PROVE II, AB-729-202) in partnership with Arbutus Biopharma. Both trials involved participants with CHB receiving standard nucleos(t)ide analogue (NUC) therapy.

Interim data from the HBV003 trial showed nearly 20% of participants had undetectable HBsAg, maintained for at least 16 weeks in two cases. Additionally, 76% of participants were eligible for NUC discontinuation, with 71% of those who discontinued remaining off NUCs by the data cutoff. Robust T cell responses were observed for all VTP-300 encoded antigens, and no serious adverse events (SAEs) were reported. 

In the IM-PROVE II trial, 20% of participants in the VTP-300 treatment group had undetectable HBsAg at Week 72, compared to none in the placebo group. Furthermore, 84% of the VTP-300 group were eligible for NUC discontinuation, with 88% remaining off NUCs, compared to 80% in the placebo group. A statistically significant reduction in HBsAg levels was observed in the VTP-300 group at Week 72. Treatment with imdusiran and VTP-300 was generally well-tolerated without any SAEs or treatment discontinuations.

Corporate updates include the appointment of Dr. Leon Hooftman as Chief Medical Officer in June 2024, bringing extensive drug development experience. The company also announced a strategic pipeline prioritization, focusing on VTP-300 for CHB and VTP-1000 for celiac disease, leading to workforce reductions.

Upcoming milestones include initiating the GLU001 Phase 1 trial for VTP-1000 in the third quarter of 2024 and announcing updated interim data from the Phase 2b HBV003 trial and Phase 2a AB-729-202 trial in the fourth quarter.

Financial highlights for the second quarter of 2024 include a cash position of $117.8 million as of June 30, 2024, compared to $130.0 million as of March 31, 2024. The net cash used in operating activities was $12.0 million, primarily due to ongoing pipeline development and clinical trials. Research and development expenses totaled $11.7 million in Q2 2024, attributed mainly to the progression of VTP-300 through two Phase 2 trials.

General and administrative expenses were $7.2 million in Q2 2024, up from $6.0 million in Q1, primarily due to a foreign exchange loss. The net loss for Q2 2024 was $16.9 million, or $(0.43) per share, compared to a net loss of $15.5 million, or $(0.40) per share in Q1.

Barinthus Biotherapeutics is dedicated to developing novel T cell immunotherapeutic candidates aimed at combating chronic infectious diseases and autoimmunity. The company leverages its proprietary platform technologies to advance product candidates like VTP-300 for HBV and VTP-1000 for celiac disease, with a robust pipeline focused on addressing significant unmet medical needs.

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