On May 13, 2024 Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer, reported its financial results for the first quarter of 2024 and provided an overview of the Company’s progress (Press release, Barinthus Biotherapeutics, MAY 13, 2024, View Source [SID1234643119]).
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"So far in 2024 we have continued to make strides across our programs. Notably, we received clearance from the FDA on an IND to progress VTP-1000 in a first in human clinical trial in celiac disease, as well as clearance from the Australian Ethics Committee on this trial. We expect to begin our Phase 1 trial of VTP-1000 in participants with celiac disease in the coming months. Additionally, we reported topline final data from the Phase 1b/2 trial of VTP-200 in participants with persistent high-risk (hr) human papillomavirus (HPV) infections," said Bill Enright, Chief Executive Officer of Barinthus Bio. "Looking ahead to Q2, we will present additional interim data from our VTP-300 hepatitis B trials at the European Association for the Study of the Liver (EASL) Congress in June. This follows the encouraging data presented at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting in November last year.
We will also welcome Dr. Leon Hooftman as our new Chief Medical Officer in June and look forward to him supporting the growth of our robust pipeline and programs."
Recent Corporate Developments
Clinical developments
•VTP-1000 (Celiac Disease): In April 2024, we received clearance from the U.S. FDA on an Investigational New Drug (IND) application, as well as from the Australian regulatory authorities, to progress VTP-1000 in a first in human clinical trial in celiac disease. GLU001 is a randomized, placebo-controlled Phase 1 trial with a controlled gluten challenge to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000 in adults with celiac disease. The study is designed in two parts; a single ascending dose part followed by a multiple ascending dose part, each randomized and placebo-controlled with three dose levels. The primary endpoint is assessment of the safety and tolerability of single and multiple dosing, and determination of a dose and schedule for further investigation. The trial also aims to demonstrate proof-of-principle of induction of immune tolerance and early proof-of-concept for VTP-1000, as a potential treatment for celiac disease, based on assessment of pharmacodynamics and preliminary efficacy determined by means of a controlled gluten challenge.
•VTP-200 (HPV): In April 2024, we announced topline final data from the APOLLO trial, (also known as HPV001) a Phase 1b/2 dose-ranging study of VTP-200 in women with low-grade cervical lesions associated with persistent hrHPV infection. The APOLLO study met its primary safety endpoint, demonstrating that VTP-200 was generally well-tolerated and was administered with no treatment-related grade 3 or higher unsolicited adverse events (AEs) and no treatment-related serious AEs. Positive trends in clearance rate for both hrHPV (60%, Group 2) and cervical lesions (67%, Groups 2 and 5), were observed in the groups receiving the highest ChAdOx dose. Pooled data from the five different active dose groups demonstrated no statistically significant improvement in either hrHPV or cervical lesion clearance in comparison to the placebo group.
•VTP-300 (HBV): In April 2024, abstracts on interim data from HBV003 and AB-729-202 were accepted for presentation at the upcoming EASL Congress in Milan, Italy, June 5-8, 2024.
Management Team
•On May 1, 2024, we announced the appointment of Dr. Leon Hooftman as Chief Medical Officer. Dr. Hooftman will join the company on June 3, 2024, and brings significant drug development expertise across a broad array of therapeutic areas including immunology, autoimmunity, hematology, oncology and infectious diseases.
Upcoming Milestones
•In the second quarter of 2024, the Company expects to:
◦VTP-300 (HBV): Present interim data from HBV003, our Phase 2b trial evaluating additional dosing of VTP-300 and timing of PD-1 inhibition, in participants with chronic hepatitis B (CHB) on nucleos(t)ide analogue (NUC) therapy at the EASL Congress in June.
◦VTP-300 (HBV): Announce interim data from the Phase 2a AB-729-202 clinical trial evaluating the combination of VTP-300 and Arbutus’ imdusiran, in participants with CHB on NUC therapy following presentation at the EASL Congress in June.
•In the third quarter of 2024, the Company expects to:
◦VTP-1000 (Celiac Disease): Dose the first patient in GLU001, a randomized, placebo-controlled Phase 1 trial with a controlled gluten challenge to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000 in adults with celiac disease. This timing update is based on the latest feasibility and expected site set-up timelines.
First Quarter 2024 Financial Highlights
•Cash position: As of March 31, 2024, cash, cash equivalents and restricted cash was $130.0 million, compared to $142.1 million as of December 31, 2023. The cash used in operating activities was $11.8 million in the first quarter of 2024, primarily resulting from development of our pipeline and ongoing clinical trials. Based on current research and development plans, the Company expects its cash runway to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025.
•Revenue: Revenue was nil in the first quarter of 2024 compared to $0.5 million in the first quarter of 2023 and was due to no commercial sales of Vaxzevria by AstraZeneca in 2024.
•Research and development expenses: Research and development expenses were $11.1 million in the first quarter of 2024 compared to $9.8 million in the first quarter of 2023, with the increase mainly attributable to hiring of personnel and increased costs related to the advancement of our programs. The quarter-on-quarter R&D expense per program is outlined in the following table.
Year ended Three months ended March 31, 2024 Three months ended March 31, 2023 Change
$000 $000 $000
Direct research and development expenses by program:
VTP-200 HPV $ 1,253 $ 1,338 $ (85)
VTP-300 HBV 1,913 2,118 (205)
VTP-500 MERS1
172 — 172
VTP-600 NSCLC2
164 275 (111)
VTP-850 Prostate cancer 178 215 (37)
VTP-1000 Celiac 1,374 1,572 (198)
Other and earlier stage programs3
784 280 504
Total direct research and development expenses $ 5,838 $ 5,798 $ 40
Indirect research and development expenses:
Personnel-related (including share-based compensation) 4,335 3,601 734
Facility related 390 371 19
Other indirect costs 562 44 518
Total indirect research and development expenses 5,287 4,016 1,271
Total research and development expense $ 11,125 $ 9,814 $ 1,311
1The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).
2The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK.
3Research and development expenses related to VTP-1100 HPV Cancer were previously included with VTP-1000 Celiac but are now included in ‘Other and earlier stage programs’ because we are focusing resources on other clinical programs and deferring the IND application for VTP-1100 in HPV cancer.
•General and administrative expenses: General and administrative expenses were $6.0 million in the first quarter of 2024, compared to $12.1 million in the first quarter of 2023. The decrease of $6.1 million relates primarily to a gain of $1.2 million on foreign exchange for the first quarter of 2024, compared to a loss of $3.5 million for the first quarter of 2023, a decrease in personnel expenses, including share-based payment charges of $0.8 million, primarily due to a reduction in non-cash share-based payment charges, and a decrease in insurance costs of $0.9 million due to a reduction in insurance premiums.
•Net loss: For the first quarter of 2024, the Company generated a net loss attributable to its shareholders of $15.5 million, or $(0.40) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $18.2 million, or $(0.48) per share on both basic and fully diluted bases in the first quarter of 2023.