Barinthus(US:BRNS)2025-08-07 12:06PART I - FINANCIAL INFORMATION Item 1. Financial Statements Presents unaudited condensed consolidated financial statements, detailing net losses, accumulated deficit, and future funding needs Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change (2025 vs 2024) | | :-------------------------------- | :------------ | :---------------- | :--------------------- | | Cash and cash equivalents | $86,259 | $110,662 | $(24,403) | | Total current assets | $100,414 | $125,742 | $(25,328) | | Total assets | $129,561 | $160,327 | $(30,766) | | Total current liabilities | $12,725 | $15,657 | $(2,932) | | Total liabilities | $27,080 | $30,192 | $(3,112) | | Total stockholders' equity | $102,481 | $130,135 | $(27,654) | | Accumulated deficit | $(278,436) | $(237,664) | $(40,772) | Condensed Consolidated Statements of Operations and Comprehensive Loss Highlights (in thousands, except per share amounts) | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expenses | $7,953 | $11,662 | $16,243 | $22,787 | | General and administrative expenses | $15,384 | $7,201 | $28,023 | $13,195 | | Total operating expenses | $23,337 | $18,863 | $44,266 | $35,982 | | Loss from operations | $(23,324) | $(18,286) | $(43,924) | $(35,200) | | Net loss | $(21,126) | $(16,943) | $(40,784) | $(32,463) | | Net loss per share, basic | $(0.52) | $(0.43) | $(1.01) | $(0.83) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(33,011) | $(23,828) | | Net cash used in investing activities | $(37) | $(500) | | Net cash provided by financing activities | $2 | $861 | | Net decrease in cash, cash equivalents and restricted cash | $(24,616) | $(24,316) | | Cash, cash equivalents and restricted cash, end of period | $87,784 | $117,774 | - The Company is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for treating autoimmune and inflammatory diseases (I&I), utilizing proprietary viral vector platform technologies (ChAdOx and MVA) and the SNAP-TI platform208788 - As of June 30, 2025, the Company had $87.8 million in cash, cash equivalents, and restricted cash, and an accumulated deficit of $278.4 million; management expects current funds to be sufficient for at least the next twelve months but anticipates incurring losses and will seek additional funding24135 Condensed Consolidated Balance Sheets Condensed Consolidated Statements of Operations and Comprehensive Loss Condensed Consolidated Statements of Changes in Stockholders' Equity Condensed Consolidated Statements of Cash Flows Notes to Condensed Consolidated Financial Statements 1. Nature of Business and Basis of Presentation 2. Summary of Significant Accounting Policies 3. Segment information 4. Foreign Currency Translation in General and Administrative Expenses 5. Net Loss Per Share 6. Property and Equipment, Net 7. Intangible Assets, Net 8. Prepaid Expenses and Other Current Assets 9. Accrued Expenses and Other Current Liabilities 10. Grant Income 11. Ordinary Shares 12. Deferred Shares 13. Fair Value 14. Share-Based Compensation 15. Commitments and Contingencies 16. Related Party Transactions Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial condition and results, emphasizing pipeline prioritization, net losses, and future financing needs - Barinthus Bio is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for autoimmune and inflammatory diseases (I&I), leveraging its proprietary SNAP-TI platform8788 - The lead candidate, VTP-1000 for celiac disease, is currently in a Phase 1 clinical trial, with the first two cohorts dosed and screening for the third ongoing; the multiple ascending dose part of the trial opened in July 2025889697 - The company incurred net losses of $21.2 million and $40.8 million for the three and six months ended June 30, 2025, respectively, and does not expect positive cash flows from operations in the foreseeable future91117126 - Research and development expenses decreased by $3.7 million (3 months) and $6.5 million (6 months) primarily due to a strategic decision to deprioritize infectious disease and oncology programs and a reduction in headcount118119120127128129 - General and administrative expenses increased significantly by $8.2 million (3 months) and $14.8 million (6 months), mainly due to unrealized foreign exchange losses on USD balances in GBP-denominated entities and increased professional fees, partially offset by reduced personnel-related expenses121130 - The company expects its existing cash, cash equivalents, and restricted cash to fund operating expenses and capital expenditure requirements into the start of 2027, but will require substantial additional financing thereafter93151 Overview Recent Developments Components of Our Operating Results Critical Accounting Policies and Use of Estimates Results of Operations Liquidity and Capital Resources Emerging Growth Company Status Recent Accounting Pronouncements Item 3. Quantitative and Qualitative Disclosure About Market Risk Discusses market risks, primarily foreign currency fluctuations (USD/GBP), and notes insignificant interest rate risk - The company is exposed to foreign currency exchange rate fluctuations, especially between the United States dollar (reporting currency) and the pound sterling (functional currency for UK subsidiaries), impacting operating costs and payables160162 - A hypothetical 10% weakening of the United States dollar relative to the pound sterling would materially change current and projected expenses denominated in pound sterling162 - Interest rate sensitivity is not significant, as the company has no substantial interest-bearing liabilities, and a 10% change in interest rates would not materially impact financial statements163 Foreign Currency and Currency Translation Interest Rate Sensitivity Item 4. Controls and Procedures Disclosure controls and procedures effective as of June 30, 2025, with no material changes in internal control - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2025164166 - No material changes in internal control over financial reporting occurred during the three and six months ended June 30, 2025167 Evaluation of Disclosure Controls and Procedures Changes in Internal Control over Financial Reporting PART II - OTHER INFORMATION Item 1. Legal Proceedings No material adverse legal claims as of June 30, 2025, though legal proceedings could incur costs and divert resources - As of June 30, 2025, the company does not believe it is party to any claim or litigation that would individually or in aggregate have no material adverse effect on its business170 - Legal proceedings, regardless of outcome, can adversely impact the company due to defense and settlement costs and diversion of management resources170 Item 1A. Risk Factors Updates risk factors: U.S. government funding, fiscal/tax policy, healthcare reforms, and U.K. Takeover Code - Inadequate funding or disruptions to U.S. government agencies like the FDA and SEC, including potential government shutdowns, could delay product development, regulatory approvals, and access to capital172173175 - Changes in U.S. fiscal and tax policies, such as the One Big Beautiful Bill Act (OBBBA), could adversely affect the company's financial condition, particularly regarding the capitalization and amortization of R&D expenses performed outside the U.S. after December 31, 2021176185 - Healthcare legislative or regulatory reforms, including executive orders aimed at lowering drug prices and state-level cost containment efforts, may lead to more rigorous coverage criteria and downward pressure on product prices, potentially hindering revenue generation and profitability178179180 - The U.K. City Code on Takeovers and Mergers currently does not apply to the company, meaning shareholders are not entitled to its protections, but this will change from February 3, 2027, if the company's securities are quoted on a UK regulated market181183 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered equity sales; $102.8 million IPO proceeds reallocated for R&D and general corporate purposes - No unregistered sales of equity securities occurred during the three and six months ended June 30, 2025191 - Net proceeds from the May 2021 IPO, approximately $102.8 million, are now allocated to advancing immune tolerance research and development programs and general corporate purposes, a change from the original plan due to pipeline prioritization193194 Item 3. Defaults Upon Senior Securities This item is not applicable to the company Item 4. Mine Safety Disclosures This item is not applicable to the company Item 5. Other Information No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements by directors or officers - None of the company's directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the fiscal quarter ended June 30, 2025198 Item 6. Exhibits Lists Form 10-Q exhibits, including Articles of Association, officer certifications, and Inline XBRL - Key exhibits include the Articles of Association, certifications of the Principal Executive Officer and Principal Financial Officer, and various Inline XBRL documents199 SIGNATURES