Core Insights - The combination of imdusiran, VTP-300, and low-dose nivolumab shows promising results in achieving HBsAg loss in chronic hepatitis B virus patients, with 23% of participants reaching HBsAg loss by Week 48 [1][3][4] Group C Clinical Trial Data - Group C consisted of 22 non-cirrhotic, virally suppressed cHBV participants, with 13 eligible for low-dose nivolumab [3][6] - Participants receiving the combination treatment of imdusiran, VTP-300, and nivolumab experienced significantly greater mean declines in HBsAg levels (p <0.017) compared to other groups [1][3] - Increases in immune biomarkers associated with T-cell activation were observed in participants who achieved HBsAg loss [3] IM-PROVE II Trial Overview - The IM-PROVE II Phase 2a clinical trial initially enrolled 40 participants, with Groups A and B receiving imdusiran followed by either VTP-300 or placebo [5] - An amendment added Group C, which included participants receiving imdusiran followed by VTP-300 and low-dose nivolumab [6] Mechanism of Action - Imdusiran is designed to reduce HBV viral proteins and antigens, facilitating immune system reawakening [8] - VTP-300 is an immunotherapeutic candidate that induces sustained reductions in HBsAg, aiming to counteract immune suppression caused by chronic HBV infection [9] Company Profiles - Arbutus Biopharma Corporation focuses on developing therapeutics for chronic hepatitis B, with a pipeline that includes imdusiran and an oral PD-L1 inhibitor [10] - Barinthus Biotherapeutics is advancing immunotherapeutic candidates, including VTP-300, targeting chronic infectious diseases and autoimmunity [11]

Financial Performance - For the year ended December 31, 2023, the company generated a net loss of $73.4 million, with an accumulated deficit of $217.1 million as of September 30, 2024[78]. - The net loss for the nine months ended September 30, 2024, was $40.6 million, an improvement from a net loss of $56.2 million in 2023[124]. - Net loss for the three months ended September 30, 2024, was $8.13 million, an improvement of $5.98 million compared to a net loss of $14.11 million in the same period in 2023[113]. - The company expects to continue incurring significant losses and negative cash flows from operations for the foreseeable future, primarily due to ongoing research and development efforts[141][142]. Revenue Generation - The company recognized $15.0 million in revenue in Q3 2024 from royalties related to prior commercial sales of Vaxzevria, compared to $0.8 million for the same period in 2023[89]. - License revenue for the three months ended September 30, 2024, was $14.97 million, compared to $0 in the same period in 2023, representing a significant increase[113]. - Revenue for the nine months ended September 30, 2024, was $15.0 million, a substantial increase from $0.8 million in the same period of 2023, attributed to the OUI License Agreement Amendment[124]. Operating Expenses - Total operating expenses increased to $24.56 million for the three months ended September 30, 2024, from $16.11 million in the same period in 2023, an increase of $8.45 million[113]. - Total operating expenses for the nine months ended September 30, 2024, were $60.5 million, down from $64.7 million in 2023, reflecting a decrease in research and development expenses[124]. - General and administrative expenses surged to $13.42 million for the three months ended September 30, 2024, compared to $0.96 million in the same period in 2023, an increase of $12.46 million[113]. Research and Development - The company has incurred significant research and development expenses, which are expected to increase as clinical trials progress[94]. - Enrollment was completed in the HBV003 trial of VTP-300 for chronic hepatitis B with 121 adult participants, aimed at obtaining critical dosing information[85]. - The first-in-human Phase 1 trial of VTP-1000 for celiac disease was initiated in September 2024, evaluating safety and pharmacodynamics[87]. - The PCA001 trial of VTP-850 for recurrent prostate cancer completed enrollment of 22 participants, with data expected in the first half of 2025[88]. - Research and development expenses decreased to $11.14 million for the three months ended September 30, 2024, down from $15.14 million in the same period in 2023, a reduction of $4.00 million[113]. Cash Flow and Financing - As of September 30, 2024, the company had cash, cash equivalents, and restricted cash totaling $106.1 million, which is expected to fund operations into the second quarter of 2026[133][148]. - For the nine months ended September 30, 2024, the company reported a net cash used in operating activities of $42.0 million, compared to $31.3 million for the same period in 2023, indicating a 34.1% increase in cash outflow[136][138]. - Cash provided by financing activities was $1.3 million for the nine months ended September 30, 2024, slightly down from $1.8 million in the same period of 2023[139]. - The company raised gross proceeds of approximately $329.2 million from the issuance of ordinary and preferred shares and convertible loan notes since inception[133]. Market and Operational Risks - The company may face limitations in claiming research and development tax credits in the future due to changes in eligibility criteria and caps introduced by the UK government[103]. - The company is not significantly exposed to market risk from interest rate changes, as it has no substantial interest-bearing liabilities[160]. - For the nine months ended September 30, 2024, a hypothetical 10% weakening of the U.S. dollar against the pound sterling would have significantly impacted current and projected expenses denominated in pounds[158].

Financial Performance - Revenue for Q3 2024 was $15.0 million, compared to nil in Q2 2024, primarily from royalties related to prior sales of Vaxzevria® by AstraZeneca[10] - Total revenue for the three months ended September 30, 2024, was $14.969 million, compared to $0.802 million for the same period in 2023, representing a significant increase[20] - The net loss attributable to shareholders for Q3 2024 was $8.1 million, or $(0.21) per share, an improvement from a net loss of $16.9 million, or $(0.43) per share, in Q2 2024[15] - The net loss for the three months ended September 30, 2024, was $8.129 million, compared to a net loss of $14.110 million for the same period in 2023, reflecting an improvement of about 42%[20] - The company reported a comprehensive income of $1.062 million for the three months ended September 30, 2024, compared to a comprehensive loss of $21.930 million for the same period in 2023[20] - The company recognized license revenue from related parties of $15.0 million for the three months ended September 30, 2024, compared to nil for the same period in 2023[20] Cash and Assets - As of September 30, 2024, Barinthus Bio reported cash, cash equivalents, and restricted cash of $106.1 million, down from $117.8 million as of June 30, 2024, with a net cash used in operating activities of $18.2 million in Q3 2024[9] - Cash, cash equivalents, and restricted cash as of September 30, 2024, totaled $106.102 million, down from $142.090 million as of December 31, 2023[19] - Total assets decreased to $188.689 million as of September 30, 2024, from $214.506 million as of December 31, 2023, representing a decline of approximately 12%[19] - Total liabilities increased to $29.228 million as of September 30, 2024, compared to $27.511 million as of December 31, 2023, indicating a rise of about 6%[19] - Total stockholders' equity attributable to Barinthus Biotherapeutics plc shareholders decreased to $159.294 million as of September 30, 2024, from $186.784 million as of December 31, 2023[19] Research and Development - Research and development expenses decreased to $11.1 million in Q3 2024 from $11.7 million in Q2 2024, mainly due to reduced personnel-related costs[11] - Research and development expenses for the three months ended September 30, 2024, were $11.139 million, down from $15.144 million in the same period of 2023, indicating a reduction of approximately 26%[20] - Enrollment in the HBV003 trial of VTP-300 for chronic hepatitis B was completed with 121 adult participants, aimed at obtaining critical dosing information for a potential functional cure[3] - The first-in-human Phase 1 AVALON trial of VTP-1000 for celiac disease was initiated in September 2024, evaluating safety and tolerability[5] - The PCA001 trial of VTP-850 for prostate cancer completed enrollment of 22 participants, with data expected in the first half of 2025[5] - Upcoming milestones include updated data from the VTP-300 program at the AASLD meeting scheduled for November 15-19, 2024[7] - An additional $15.0 million in revenue is expected from Oxford University Innovation related to royalties, which will support R&D plans into Q2 2026[6] Expenses - General and administrative expenses increased to $13.4 million in Q3 2024 from $7.2 million in Q2 2024, largely due to a foreign exchange loss of $7.7 million[14]

Core Insights - Barinthus Biotherapeutics plc is advancing its clinical trials and has reported financial results for Q3 2024, highlighting significant progress in its pipeline, particularly in chronic hepatitis B and celiac disease treatments [1][2]. Clinical Developments - The company completed enrollment in the HBV003 trial of VTP-300 for chronic hepatitis B with 121 adult participants, aiming for a potential functional cure [3]. - Interim data from the HBV003 trial showed that 76% of participants met criteria for nucleos(t)ide analogue therapy discontinuation, with 19% achieving undetectable HBsAg levels [4]. - The first-in-human Phase 1 AVALON trial of VTP-1000 for celiac disease was initiated, focusing on safety and pharmacokinetics [5]. - Enrollment for the PCA001 trial of VTP-850 in prostate cancer was completed with 22 participants, with data expected in the first half of 2025 [6]. Financial Performance - As of September 30, 2024, the company reported cash and equivalents of $106.1 million, down from $117.8 million at the end of Q2 2024, with a net cash usage of $18.2 million in Q3 [9]. - Revenue for Q3 2024 was $15.0 million, attributed to royalties from Oxford University Innovation, compared to no revenue in Q2 2024 [9]. - Research and development expenses decreased to $11.1 million in Q3 2024 from $11.7 million in Q2 2024, primarily due to reduced personnel costs [9][10]. - General and administrative expenses rose to $13.4 million in Q3 2024, largely due to a foreign exchange loss of $7.7 million [12]. - The net loss for Q3 2024 was $8.1 million, or $(0.21) per share, an improvement from a net loss of $16.9 million in Q2 2024 [12][19]. Upcoming Milestones - Updated data from the VTP-300 program is expected in Q4 2024, with presentations at the AASLD – The Liver Meeting® 2024 [7]. - Data from the Phase 1 AVALON trial of VTP-1000 is anticipated in the first half of 2025 [8]. - Results from the Phase 1 PCA001 trial of VTP-850 are also expected in the first half of 2025 [8].

Table of Contents (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to ________ Commission File Number: 001-40367 BARINTHUS BIOTHERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) Engl ...

Barinthus Bio Reports Second Quarter 2024 Update on Corporate Developments and Financial Results OXFORD, United Kingdom, August 8, 2024 (GLOBE NEWSWIRE) – Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinicalstage biopharmaceutical company developing novel T cell immunotherapeutic candidates, provided an overview of the Company's progress and announced its financial results for the second quarter of 2024. "Following the positive VTP-300 Phase 2 data in hepatitis B virus (HBV) in the second quarter, we ma ...

SAN MATEO, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the appointments of two biotechnology industry leaders, Anne Phillips and Jennifer Jarrett, to the board of directors of the Company, effective August 1, 2024. "We are thrilled to welcome Anne and Jennifer to our board as we prep ...

OXFORD, United Kingdom, June 12, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates, today announced plans to prioritize its pipeline to focus on the development of VTP-300 in CHB and VTP-1000 in celiac disease. The development of VTP-300 in CHB and VTP-1000 in celiac disease will be prioritized and the ongoing Phase 1 clinical trial of VTP-850 in prostate cancer will be completed. The Company ...

The development of VTP-300 in chronic Hepatitis B (CHB) and VTP-1000 in celiac disease will be prioritized. The pipeline prioritization is expected to result in a reduction in workforce of approximately 25% and an estimated extension to the cash runway into the second quarter of 2026. The decision follows the positive interim data from the two ongoing Phase 2 clinical trials presented at the European Association for the Study of the Liver (EASL) Congress on June 6, 2024. The data from the ongoing HBV003 and ...

In the HBV003 trial, 67% of participants had HBsAg <10 IU/mL and 19% of participants had undetectable HBsAg when assessed for NUC discontinuation (end of treatment) or later, and 76% of participants were eligible for nucleos(t)ide analogue (NUC) therapy discontinuation. In the IM-PROVE II trial, conducted in partnership with Arbutus Biopharma, a statistically significant difference was observed in HBsAg levels between the VTP-300 treatment and placebo groups at 24- weeks post-end of treatment (EOT) and 84% ...