On March 20, 2024 Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, reported its financial results for the year ended December 31, 2023, and an overview of the Company’s progress (Press release, Barinthus Biotherapeutics, MAR 20, 2024, View Source [SID1234641288]). Barinthus Bio is 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.
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"2023 was a productive year for Barinthus Bio, with data presented in our HBV and HPV programs, the first patient visit in our next generation prostate cancer program and up to $35 million of future funding committed from the Coalition for Epidemic Preparedness Innovations (CEPI) secured for our MERS program," said Bill Enright, Chief Executive Officer of Barinthus Bio. "We expect another data rich year in 2024, with anticipated final results from our Phase 1b/2 HPV APOLLO trial of VTP-200, and additional data from our two ongoing Phase 2 trials of VTP-300 in chronic HBV infection. In addition, our SNAP-TI platform is heading into the clinic for the first time as we expect to initiate a Phase 1 clinical trial of VTP-1000 in celiac disease, our lead program in autoimmunity."
2023 Corporate Milestones
Clinical Developments
HBV (VTP-300):
•In March 2023, we announced positive topline final data from the HBV002 Phase 2 clinical trial for VTP-300 in Chronic Hepatitis B (CHB). The data showed meaningful, durable reductions of Hepatitis B Surface Antigen (HBsAg) in all participants with a >0.5 log10 reduction in HBsAg who received VTP-300 alone or in combination with a single administration of low-dose PD-1 inhibitor, nivolumab. Two of five patients with baseline HBsAg below 100 IU/mL in Group 3, developed a non-detectable HBsAg level, which continued eight months after last dose. We presented the final data in June 2023 at the European Association for the Study of the Liver Congress 2023 – The International Liver CongressTM.
•In November 2023, we presented interim data from the HBV003 Phase 2b clinical trial for VTP-300 in CHB showing that VTP-300 in combination with nivolumab continued to show sustained HBsAg reductions, particularly in patients with HBsAg levels below or equal to 200IU/mL at screening. We presented this data during an oral presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting 2023.
•Also in November 2023, interim data from the Phase 2a AB-729-202 clinical trial in collaboration with Arbutus Biopharma Corporation (Arbutus) in CHB patients were presented at AASLD, showing that imdusiran in combination with VTP-300 demonstrated meaningful and sustained declines in HBsAg levels.
HPV (VTP-200):
•In March 2023, we announced favorable topline interim data from the HPV001 Phase 1b/2 clinical trial of VTP-200 in high-risk HPV (hrHPV) infection.
•In April, we presented interim data from the VTP-200 APOLLO (HPV001) Phase 1b/2 clinical trial in hrHPV infection at the 35th Annual International Papillomavirus Conference. Immunological results showed VTP-200 induced high T cell responses to HPV antigens, and was generally well-tolerated with no product-related grade 3 unsolicited events and no product-related SAEs.
Celiac Disease (VTP-1000):
•In December 2023, we submitted an Australian ethics submission and regulatory notification to the Alfred Research Review Committee for the Phase 1 GLU001 study in Celiac disease.
Prostate Cancer (VTP-850):
•In June 2023, we announced the dosing of the first patient in the PCA001 Phase 1/2 clinical trial for VTP-850 in prostate cancer.
MERS (VTP-500):
•In December 2023, we announced an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford, aiming to fast-track the development of our vaccine candidate, VTP-500, for the prevention of Middle East Respiratory Syndrome. This agreement includes CEPI investing funding of up to $35 million to Barinthus Bio in addition to funds previously committed to the University of Oxford to develop and stockpile a ready reserve of VTP-500.
Key Operational Updates
•In January 2023, we announced the appointment of Nadège Pelletier, Ph.D., as Chief Scientific Officer.
•In June 2023, we completed the move of our U.S. facility to Germantown, Maryland, which houses a state-of-the art wet laboratory and office space.
•In November 2023, we announced the company’s renaming as Barinthus Biotherapeutics plc to represent the evolution and expansion of its focus beyond vaccines. As part of the renaming, the Company changed its Nasdaq ticker to "BRNS", which became effective on Nasdaq on November 7, 2023.
Upcoming Milestones
In 2024, the Company expects to:
•Q2 2024:
◦HBV:
Announce interim data from HBV003, our Phase 2b trial evaluating additional dosing of VTP-300 and timing of PD-1 inhibition, in people with CHB on NUC therapy.
Announce interim data from the Phase 2a AB-729-202 clinical trial evaluating the combination of VTP-300 and Arbutus’ imdusiran, in people with CHB on NUC therapy.
◦HPV:
Announce final results from participants receiving VTP-200 in the Phase 1b/2 APOLLO (HPV001) trial evaluating the safety, immunogenicity and efficacy of VTP-200 in persistent HPV infection and low-grade cervical lesions.
◦Celiac disease:
Initiate a Phase 1 clinical trial of VTP-1000.
•Q4 2024:
◦HBV:
Announce more mature interim data from HBV003, our Phase 2b trial evaluating additional dosing of VTP-300 and timing of PD-1 inhibition, in people with CHB on NUC therapy.
Announce more mature interim data from the Phase 2a AB-729-202 clinical trial evaluating the combination of VTP-300 and Arbutus’ imdusiran, in people with CHB on NUC therapy.
2023 Financial Highlights
•Cash position: As of December 31, 2023, cash was $142.1 million, compared to $194.4 million as of December 31, 2022. The cash used in operating activities was $50.9 million, primarily resulting from our net loss of $73.4 million, adjusted by foreign exchange loss on translation of $7.5 million, share-based compensation of $5.1 million, depreciation and amortization of $5.4 million, deferred tax movements of $3.1 million and changes in our operating assets and liabilities, net of $6.2 million primarily related to a $5.8 million decrease in accounts receivable, a $2.2 million decrease in prepaid expenses and other current assets, $3.4 million decrease in accounts payable and $2.0 million increase in accrued expenses.
•Revenue: Revenue was $0.8 million in 2023 compared to $44.7 million in 2022 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, sales of which reduced significantly in 2023 when compared to 2022.
•Research and development expenses: Research and development expenses were $44.9 million in 2023 compared to $42.4 million in 2022, demonstrating the progression of our pipeline through the clinic. Direct research and development expenses reduced $0.6 million, comprising of a $3.3 million increase in expense on the SNAP platform candidates, namely VTP-1000, offset by a reduction in expense of $2.4 million due to the phasing of VTP-300 in two ongoing Phase 2 clinical trials, and a $2.3 million reduction as a result of VTP-850 getting into the clinic in a Phase 1/2 clinical trial in prostate cancer. Indirect research and development expenses increased $3.1 million as a result of an increase in headcount attributing to an increase in personnel costs of $2.3 million and an increase in facility costs due to moving the U.S. office to a 19,700 square foot, state-of-the-art wet laboratory and office facility in Germantown, Maryland, in June 2023. The year-on-year R&D expense per program is outlined in the following table.
Year ended December 31,
2023 December 31,
2022 Change
$000 $000 $000
Direct research and development expenses by program:
VTP-200 HPV $ 4,950 $ 4,050 $ 900
VTP-300 HBV 11,276 13,700 (2,424)
VTP-600 NSCLC1
597 532 65
VTP-850 Prostate cancer 2,726 5,011 (2,285)
VTP-1000/VTP-1100 Celiac/HPV Cancer 8,420 5,118 3,302
Other and earlier stage programs 1,787 1,916 (129)
Total direct research and development expenses $ 29,756 $ 30,327 $ (571)
Indirect research and development expenses:
Personnel-related (including share-based compensation) 12,702 10,424 2,278
Facility-related 1,339 1,308 31
Other internal costs 1,077 291 786
Total indirect research and development expenses 15,118 12,023 3,095
Total research and development expense $ 44,874 $ 42,350 $ 2,524
1The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK.
•General and administrative expenses: General and administrative expenses were $39.8 million in 2023, compared to $6.4 million in 2022. The increase is primarily attributable to a $7.6 million loss on foreign exchange in 2023 compared to a $26.4 million gain on foreign exchange in 2022 as a result of movements in the USD:GBP exchange rate during the respective periods.
•Net loss: For the financial year 2023, the Company generated a net loss attributable to its shareholders of $73.3 million, or $1.91 per fully diluted share and per basic share, compared to a net income attributable to shareholders of $5.3 million, or $0.14 per fully diluted share and per basic share, for 2022.