Barinthus(US:BRNS)2023-11-08 16:00Financial Performance - The company incurred a net loss of $56.2 million for the nine months ended September 30, 2023, compared to a net income of $5.3 million for the year ended December 31, 2022[112]. - The company reported a net loss of $14.1 million for the three months ended September 30, 2023, compared to a net income of $8.2 million in the same period of 2022, reflecting a change of $22.3 million[193]. - Revenue for the nine months ended September 30, 2023, was $0.8 million, a significant decrease from $38.2 million in the same period of 2022, primarily due to changes in the OUI License Agreement[172]. - Revenue for the three months ending September 30, 2023, was $0, while revenue for the nine months was $0.8 million, a significant decrease from $6.2 million and $38.2 million for the same periods in 2022[152]. - The accumulated deficit as of September 30, 2023, was $159.3 million, indicating ongoing financial challenges[228]. - The company expects to continue incurring significant losses and negative cash flows from operations for the foreseeable future[228]. Cash Flow and Financing - As of September 30, 2023, the company had cash and cash equivalents of $160.3 million[224]. - The company expects its existing cash and cash equivalents of $160.3 million as of September 30, 2023, to fund operating expenses and capital expenditures into the second quarter of 2025[233]. - Net cash used in operating activities for the nine months ended September 30, 2023, was $31.3 million, compared to $3.1 million in the same period of 2022[226]. - Cash provided by financing activities for the nine months ended September 30, 2023, was $1.8 million, while cash used in financing activities in the same period of 2022 was $0.2 million[211]. - The company plans to finance future cash needs through public or private equity offerings, debt financings, collaborations, or licensing arrangements[251]. Research and Development - The company is advancing a pipeline of five product candidates, including VTP-300 and VTP-200, which are in Phase 2 clinical trials[109]. - Research and development expenses for the nine months ended September 30, 2023, were $38.5 million, an increase of $8.3 million compared to $30.2 million in the same period of 2022[221]. - Total research and development expenses for the three months ended September 30, 2023, were $15.1 million, an increase of $5.4 million from $9.7 million in the same period of 2022[195]. - Direct research and development expenses for the nine months ended September 30, 2023, totaled $27.1 million, up from $21.5 million in 2022, reflecting a change of $5.6 million[173]. - The VTP-1000/VTP-1100 Celiac/HPV Cancer program incurred $7.1 million in direct expenses for the nine months ended September 30, 2023, with no expenses recorded in the prior year[173]. - Research and development incentives for the nine months ended September 30, 2023, were $2.9 million, compared to $1.2 million in the same period of 2022[205]. - The company has not generated any revenue from direct product sales and does not expect to do so in the near future[137]. Operating Expenses - The company has incurred operating expenses primarily from research and development and general administrative costs, with expectations for these expenses to continue rising as operations expand in the UK and US[140]. - General and administrative expenses for the nine months ended September 30, 2023, were $26.2 million, a significant increase from a gain of $13.0 million in the same period of 2022, primarily due to a foreign exchange gain[203]. - General and administrative expenses for the three months ended September 30, 2023, were $1.0 million, primarily due to personnel-related expenses of $3.4 million, offset by foreign exchange gains of $6.6 million[197]. - The company incurred expenses of $0.1 million related to clinical study costs owed to the University of Oxford as of September 30, 2023[106]. Assets and Liabilities - The company recorded amortizable intangible assets of $31.6 million as of September 30, 2023, with accumulated amortization of $5.7 million[126]. - The company has a goodwill of $12.2 million as of September 30, 2023, related to the acquisition of Avidea, with no impairment losses recognized for the three or nine months ending September 30, 2023[167]. - The acquisition of Avidea was completed for an upfront amount of $32.8 million, with potential additional payments of up to $40.0 million based on milestone achievements[190]. Market and Operational Risks - The company believes the impact of the ongoing international conflicts in Israel, Gaza, and Ukraine on its operations will be minimal due to no direct involvement or suppliers in those regions[149][150]. - The company faces potential challenges in claiming future research and development tax credits due to changes in eligibility criteria and caps introduced by the UK Finance Act of 2021[156]. - The company has significant operating costs in the U.K. and faces exposure to fluctuations in foreign currency exchange rates, particularly with the euro and pound sterling[237]. - The company is not currently exposed significantly to market risk related to changes in interest rates, as it has no significant interest-bearing liabilities[239]. Internal Controls and Governance - The company is taking measures to address material weaknesses in its internal control over financial reporting, including implementing a new ERP system[243]. - The company has identified material weaknesses in its disclosure controls and procedures as of September 30, 2023, which have not been remediated[258]. - The company continues to evaluate and enhance business process controls to improve the effectiveness of its accounting and reporting functions[244]. Corporate Changes - The company changed its name to Barinthus Biotherapeutics plc and its ticker to BRNS on Nasdaq effective November 7, 2023, reflecting its expanded focus beyond vaccines[148]. - The company was authorized to allot shares up to an aggregate nominal amount of £1,928 free from statutory pre-emption rights as of November 6, 2023[147].