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Item 7. Management’s Discussion and Analysis

2026-03-13 compared with 2025-03-20 · 134 added, 144 removed, 214 unchanged (57% of the section changed)

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You should carefully read the “Special Note Regarding Forward Looking Statements” and “Risk Factors” sections of this Annual Report to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements contained in the following discussion and analysis.

We are a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for treating auto-immune and inflammatory diseases within the immunology and inflammation ("I&I") space.

We are a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for treating autoimmune and inflammatory diseases within the immunology and inflammation ("I&I") space.

Helping patients and their families is the guiding principle at the heart of Barinthus Bio.

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We are prioritizing the development of a pipeline for I&I indications enabled by our proprietary and highly differentiated platform for promoting immune tolerance, referred to as SNAP-TI, that are designed to guide patient's T cells to reduce inflammation and restore the natural state of immune non-responsiveness to healthy tissue.

Our lead candidate, VTP-1000, is designed to restore immune non-responsiveness to gluten in patients with celiac disease, and is currently being assessed in a Phase 1 clinical trial.

Our lead candidate, VTP-1000, is designed to restore immune non-responsiveness to gluten in patients with celiac disease, and is currently being assessed

in a Phase 1 clinical trial.

Based on encouraging preclinical data, we believe that the SNAP-TI platform has the potential to impact multiple other I&I indications.

We are also evaluating two product candidates to treat infectious diseases and cancer that harness our proprietary viral vector platform technologies, consisting of ChAdOx and MVA;

these technologies are designed to increase disease-specific CD8+ T cells.

These include:

VTP-300, a Phase 2 immunotherapeutic treatment modality that is a component of a treatment regimen to establish functional cure in patients who are chronically infected by the hepatitis B virus, and VTP-850, a second-generation immunotherapeutic candidate for the prevention of recurrence of prostate cancer.

VTP-850 is being tested in patients in a Phase 1 clinical trial in prostate cancer after surgical resection.

We intend to progress the development of these product candidates by completing the ongoing clinical trials, and seek a partner or collaborator for continuing development.

Alongside these proprietary programs, we have partnerships in place to advance additional prophylactic and therapeutic product candidates utilizing our viral vector platforms, including VTP-500 for Middle East Respiratory Syndrome, or MERS, VTP-400 for Herpes Zoster infections, and VTP-600 with potential for multiple cancer indications, including Non-Small Cell Lung Cancer ("NSCLC"), and Squamous Esophageal Cancer.

We also co-invented a COVID-19 vaccine with the University of Oxford, which was exclusively licensed worldwide to AstraZeneca U.K.

Limited ("AstraZeneca").

We believe our core capabilities at the intersection of T cell immunology and immunotherapeutic technology platforms combined with our track record of successfully executing development path activities uniquely position us to navigate towards delivering promising new treatments for patients with auto-immune and inflammatory diseases and building value for shareholders.

On August 9, 2022, we filed a Registration Statement on Form S-3, as amended, or the Shelf, with the Securities and Exchange Commission in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by American Depositary Shares, or ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million.

The Shelf was declared effective on August 17, 2022.

We also simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, providing for the offering, issuance and sale by us of up to an aggregate of $75.0 million of our ordinary shares represented by ADSs from time to time in “at-the-market” offerings under the Shelf.

As of December 31, 2024, we sold 2,558,586 ordinary shares represented by ADSs under the sales agreement, amounting to net proceeds of $5.1 million.

We have incurred net losses each year since inception through to December 31, 2021.

For the year ended December 31, 2022, we generated net income of $5.3 million, primarily as a result of revenues arising from AstraZeneca sales of Vaxzevria and our agreement with OUI.

We are also exploring partnership opportunities for VTP-300, a product candidate to treat CHB that harnesses viral vector platform technologies, consisting of ChAdOx and MVA;

which are designed to increase disease-specific CD8+ T cells.

VTP-300 is a Phase 2 immunotherapeutic treatment modality that is a component of a treatment regimen to establish functional cure in patients who are chronically infected by the hepatitis B virus.

We believe our core capabilities at the intersection of T cell immunology and immunotherapeutic technology platforms combined with our track record of successfully executing development path activities uniquely position us to navigate towards delivering promising new treatments for patients with autoimmune and inflammatory diseases and building value for shareholders.

In September 2025, we entered into the Merger Agreement to combine in an all-stock transaction with Clywedog.

The newly combined company will advance a differentiated portfolio of clinical-stage candidates targeting metabolic and autoimmune diseases, with four clinical data milestones expected within 18 months of the closing of the transaction.

Upon the closing of the transaction, the combined company will be renamed “Clywedog Therapeutics Holdings, Inc.” and is expected to trade on the Nasdaq under the new ticker symbol “CLYD.” The transaction is expected to close in the second quarter of 2026, supported by existing cash and additional investments by OrbiMed and TPAV, LLC, both existing shareholders in Clywedog, and new investors.

We have incurred net losses in each annual and interim reporting period since 2023.

For the years ending December 31, 2025 and 2024, we incurred net losses of $66.5 million and $61.2 million, respectively.

As of December 31, 2024 and 2023, we had an accumulated deficit of $237.7 million and $176.6 million, respectively, and we do not currently expect profits or positive cash flows from operations in the foreseeable future.

We expect to incur net operating losses for at least the next several years as we advance our product candidates through clinical development, seek regulatory approval, prepare for approval, and in some cases proceed to commercialization of our product candidates, as well as continue our research and development efforts and invest to establish a commercial manufacturing facility, as and when appropriate.

As of December 31, 2025 and 2024, we had an accumulated deficit of $304.1 million and $237.7 million, respectively, and we do not currently expect positive cash flows from operations in the foreseeable future.

At this time, we cannot reasonably estimate, or know the nature, timing and estimated costs of all of the efforts that will be necessary to complete the development of any of our product candidates that we develop through our programs.

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• sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;

• acceptance of investigational new drug applications, or INDs, for our planned clinical trials or future clinical trials;

• acceptance of INDs for our planned clinical trials or future clinical trials;

• successful and timely enrollment and completion of clinical trials;

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• establishing either our own manufacturing capabilities or satisfactory agreements with third-party manufacturers for clinical supply for later stages of development and commercial manufacturing;

• entry into collaborations where appropriate to further the development of our product candidates;

• entry into collaborations or partnerships, where appropriate, to further the development of our product candidates;

• obtaining and maintaining intellectual property and trade secret protection or regulatory exclusivity for our product candidates as well as qualifying for, maintaining, enforcing and defending such intellectual property rights and claims;

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Furthermore, our operating plans may change in the future owing to research outcomes or other opportunities, and we may need additional funds to meet operational needs and capital requirements associated with such altered operating plans.

Unless and until we can generate a substantial amount of revenue from our product

candidates, if approved, we expect to finance our future cash needs through public or private equity offerings, debt financings, collaborations, licensing arrangements or other sources, or any combination of the foregoing.

Based on our research and development plans, we expect that our existing cash, cash equivalents and restricted cash and other financial resources, will enable us to fund our operating expenses and capital expenditure requirements to the start of 2027.

Unless and until we can generate a substantial amount of revenue from our product candidates, if approved, we expect to finance our future cash needs through public or private equity offerings, debt financings, collaborations, licensing arrangements or other sources, or any combination of the foregoing.

Based on our current standalone research and development plans, we expect that our existing cash, cash equivalents, restricted cash and other financial resources will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months.

These estimates are based on assumptions that may prove to be wrong, and we could use our available capital resources more quickly than we expect.

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Recent Developments

On January 10, 2025, we announced that we will prioritize I&I indications, including antigen-specific immune tolerance.

As a result, we have extended the cash runway to the start of 2027 by reducing forecasted costs, including a reduction in headcount by approximately 65% across both the U.K.

sites, and streamlining the operating costs of the business.

We estimate that the pre-tax costs of such reduction in workforce relating to employee severance and other employee-related costs may be approximately $2.5 million with the majority of such costs being incurred in the first half of 2025.

The estimates of the restructuring costs that we expect to incur and potential operating expense reductions, and the timing thereof, are subject to a number of assumptions and actual results may differ.

As part of the restructuring, two of the executive leadership team members based in the U.K., the Chief Operating Officer, Graham Griffiths, and Chief Financial Officer, Gemma Brown, will leave the Company.

Further plans for the re-organized team will be communicated in due course.

We will not invest in VTP-300 in chronic hepatitis B beyond the completion of the ongoing Phase 2b HBV003 clinical trial and will seek potential partners able to take advantage of its differentiated ability to achieve sustained HBsAg loss and functional cure in patients with low levels of HBsAg.

Impact of Israel and Gaza Conflict, Ukraine Crisis and Iran Conflict

In respect of the international conflict in Israel and Gaza, situation in Ukraine and Iran conflict, we have no operations or suppliers based in Israel or Gaza, or in Ukraine, Belarus, Russia or Iran, and as a result, as of the date of this Annual Report on Form 10-K, we believe the impact on our business, operations and financial condition will be minimal.

Merger Agreement Amendment

In February 2026, we announced we have entered into an amendment to the Merger Agreement with Clywedog to update the exchange ratio framework to provide additional flexibility in finalizing the transaction terms and to revise certain minimum cash requirements to reflect anticipated transaction timing.

All other material terms remain unchanged.

Nasdaq Listing Rule Compliance

On January 6, 2026, we announced we received a letter from the Nasdaq indicating that the closing bid price of our ADSs, each representing one ordinary share of the Company, was below $1.00 per share for 30 consecutive business days, and that, therefore, we are not in compliance with Nasdaq Listing Rule 5450(a)(1), which is the minimum bid price requirement for continued listing on the Nasdaq Global Market.

The notice from Nasdaq has no immediate effect on the listing of the ADSs, and the ADSs will continue to be listed on the Nasdaq Global Market under the symbol “BRNS.” Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we have automatically been afforded a 180-calendar day period, or until June 29, 2026, to regain compliance with the minimum bid price requirement.

The continued listing standard will be met if the closing bid price of the ADSs is at least $1.00 per share for a minimum of ten consecutive business days during the 180-calendar day period.

If we are not in compliance by June 29, 2026, we may be afforded a second 180-calendar day period to regain compliance if it meets certain requirements.

We intend to monitor the closing bid price of the ADSs and are currently evaluating our options for regaining compliance, which could include a reverse stock split of the ADSs.

Impact of International Conflict

In respect of the international conflicts in Gaza, Ukraine and Iran, we have no operations or suppliers based in Israel, Gaza, Ukraine, Belarus, Russia or Iran, and as a result, as of the date of this Annual Report on Form 10-K, we believe the impact on our business, operations and financial condition will be minimal.

Impact of Global Economic Conditions and Inflationary Pressures

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In October 2024, we were informed of additional amounts due to the Company from Oxford University Innovation Limited (OUI) in relation to the Company's share of royalties received by OUI as a result of prior commercial sales of Vaxzevria by AstraZeneca.

As a result, our revenue for the year ending December 31, 2024 was $15.0 million (year ended December 31, 2023 $0.8 million), representing the amounts we have been notified of as due by OUI to date.

As a result there was no revenue for the year ending December 31, 2025 (year ended December 31, 2024 $15.0 million), representing the amounts we have been notified of as due by OUI to date.

We do not expect to receive any further payments relating to future commercial sales of Vaxzevria and, if such payments are due, that we will be notified of such payments in a timely manner.

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Research and Development Expenses

Since our inception, we have focused significant resources on our research and development activities, including establishing and building on our adenovirus platform, further enhancing our in-licensed ChAdOx1, ChAdOx2 and MVA vectors, acquiring new technology platforms including SNAP-TI and SNAP-CI, conducting preclinical studies, developing various manufacturing processes, initiating the clinical trials for VTP-1000, VTP-200, VTP-300, VTP-600, VTP-850 and readying VTP-500 for clinical trials.

Research and development activities account for a large portion of our operating expenses, and we expect research and development expenses for our ongoing clinical programs to increase in the future.

Since our inception, we have focused significant resources on our research and development activities, including establishing and building on our adenovirus platform, further enhancing our in-licensed ChAdOx1, ChAdOx2 and MVA vectors, developing a next-generation adenoviral vector, acquiring new technology platforms including SNAP-TI and SNAP-CI, conducting preclinical studies, developing various manufacturing processes, and advancing our clinical programs.

Research and development activities account for a large portion of our operating expenses, and product candidates in later stages of development generally have higher development costs than those in earlier stages, due to larger and more complex clinical trials, manufacturing scale-up and an increase in research and development headcount to oversee these activities.

We are currently seeking partners to fund or collaborate on certain of our programs, including VTP-300 and VTP-850, which we do not intend to develop beyond the completion of the ongoing trials, as applicable.

We expect research and development expenses to increase in the future as we progress our program through the next stage of development.

Research and development costs are expensed as incurred.

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• salaries, benefits, and other related costs, including share-based compensation, for personnel engaged in research and development functions;

• expenses incurred in connection with the development of our programs including preclinical studies and clinical trials of our product candidates, under agreements with third parties, such as consultants, contractors, academic institutions and contract research organizations, or CROs;

• the cost of manufacturing drug products for use in preclinical development and clinical trials, including agreements with third parties, such as contract manufacturing organizations, consultants and contractors;

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General and Administrative Expenses

Our general and administrative expenses consist of personnel-related expenses, including share-based compensation, in our executive, finance, business development and other administrative functions.

Other general and administrative expenses include consulting fees and professional service fees for auditing, tax and legal services, rent expenses related to our offices, depreciation, impairment of long-lived assets, foreign exchange gains and losses on our cash balances, other central non-research costs and changes in the fair value of contingent consideration.

Our general and administrative expenses consist primarily of personnel-related expenses, including share-based compensation, in our executive, finance, business development and other administrative functions.

Other general and administrative expenses include consulting fees and professional service fees for auditing, tax and legal services, rent expenses related to our offices, depreciation, impairment of property and equipment and right-of-use assets, foreign exchange gains and losses on our cash balances, other central non-research costs and changes in the fair value of contingent consideration.

When determining the fair value of contingent consideration, significant judgment is used to determine the probability of success of achievement of the technology and clinical milestones and the date of the expected milestone.

We expect our general and administrative expenses to continue to increase in the future as we expand our operating activities and potentially prepare for manufacturing and/or commercialization of our current and future product candidates.

These costs will increase if our headcount rises to allow full support for our operations, including increased expenses related to legal, accounting, regulatory and tax-related services associated with maintaining compliance with requirements of the Nasdaq Global Market and the Securities and Exchange Commission, directors’ and officers’ liability insurance premiums and investor relations activities.

Our general and administrative expenses would continue to increase in the future if we expand our operating activities and if we seek to manufacture and/or commercialize any of our current and future product candidates.

These costs will increase if our headcount rises to allow full support for our operations as a public company, including increased expenses related to legal, accounting, regulatory and tax-related services associated with maintaining compliance with requirements of the Nasdaq and the SEC, directors’ and officers’ liability insurance premiums and investor relations activities.

Other Operating Income

Other operating income includes grant income from CEPI Funding Agreement pursuant to which CEPI will provide funding to us to advance the development of VTP-500, our vaccine candidate against MERS.

Other operating income includes grant income from an agreement (the "CEPI Funding Agreement") with the Coalition for Epidemic Preparedness Innovations ("CEPI") pursuant to which CEPI will provide funding to us to advance the development of VTP-500, a vaccine candidate against MERS.

When there is reasonable assurance that we will comply with the conditions attached to a received grant, and when there is reasonable assurance that the grant will be received, grant income is recognized as other operating income on a gross basis in the consolidated statements of operations and comprehensive loss on a systematic basis over the periods in which we recognize expenses for the related costs for which the grants are intended to compensate.

Payments received in advance of incurring reimbursable expenses are recorded as deferred income.

Any remaining unused amounts of the cash payments will be disclosed as restricted cash in the consolidated financial statements.

Any remaining unused amounts of the cash payments received on the balance sheets will be disclosed as restricted cash in the notes of the consolidated financial statements.

Minimal future activity is expected in relation to the VTP-500 program following the strategic decision to prioritize pipeline assets in the I&I space.

Other Income/(Expense)

Interest Income

Interest income results primarily from the interest earned on our short-term cash deposits and cash balances held by Barinthus Biotherapeutics (U.K.) Limited.

Interest income results primarily from the interest earned on our short-term cash deposits and cash balances held by Barinthus Biotherapeutics (UK) Limited.

Interest Expense

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Research and Development Incentives

Research and development incentives contain payments receivable from the United Kingdom government related to corporation tax relief on research and development projects in the United Kingdom.

Research and development incentives contain payments receivable from the U.K.

government related to corporation tax relief for qualifying expenditure on research and development projects in the U.K.

We account for such relief received as other income.

We benefit from the United Kingdom research and development tax credit regime, being the Small and Medium-sized Enterprises R&D tax relief program or SME Program, and, to the extent that our projects are grant funded or relate to work subcontracted to us by third parties, the Research and Development Expenditure Credit program, or RDEC Program.

Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs, externally provided workers and utilities costs incurred as part of research projects.

A large portion of costs relating to research and development, clinical trials and manufacturing activities are eligible for inclusion within these tax credit cash rebate claims.

From March 2023, under the SME program, we are able to surrender some of our trading losses that arise from qualifying research and development activities for a cash rebate of up to 18.6% of such qualifying research and development expenditure, as the SME additional deduction is 86% and the SME credit rate is 10%, unless the SME qualifies as an R&D intensive business;

that is, R&D expenditure constitutes at least 40% (from April 1, 2023) or 30% (from accounting periods starting on or after April 1, 2024) of total expenditure.

From the analysis performed, we have not and do not currently expect to claim under the loss-making R&D Intensive Scheme for SMEs primarily due to the proportion of total relevant expenditure occurring outside the United Kingdom.

We may not be able to continue to claim research and development tax credits under the United Kingdom research and development tax credit regime because we may no longer qualify based on the eligibility criteria.

Further, the U.K.

Finance Act of 2021 introduced a cap on payable credit claims under the SME Program in excess of £20,000 with effect from April 2021 by reference to, broadly, three times the total Pay As You Earn, or PAYE, and National Insurance Contributions, or NICs, liability, subject to an exception which prevents the cap from applying.

That exception requires us to create, take steps to create or manage intellectual property, as well as having qualifying research and development expenditure in respect of connected parties, which does not exceed 15% of the total claimed.

If such an exception does not apply, this could restrict the amount of payable credit that we claim.

There was no tax loss restriction applied to the R&D tax credits in the U.K.

for the year ended December 31, 2023 and 2024.

The merged scheme Research & Development expenditure credit (RDEC) and enhanced R&D intensive support (ERIS) replaces the old RDEC and small and medium-sized enterprise (SME) schemes for accounting periods beginning on or after April 1, 2024.

For expenditure under the merged scheme, the rate of Research and Development expenditure credit will be 20%, which is the same as the rate under the old RDEC scheme for expenditure incurred on or after April 1, 2023.

For 2025, we benefit from the applicable U.K.

research and development tax credit regime which is the merged scheme Research & Development expenditure credit ("RDEC") and enhanced R&D intensive support ("ERIS") that replaces the old RDEC and small and medium-sized enterprise ("SME") schemes for accounting periods beginning on or after April 1, 2024.

For expenditure under the merged scheme, the rate of Research and Development expenditure credit is 20%, which is the same as the rate under the old RDEC scheme for expenditure incurred on or after April 1, 2023.

For loss-makers and small profit-makers, a lower rate of notional tax restriction (currently 19%) applies at payment.

For all other companies, the restriction will continue to apply at the Corporation Tax main rate (currently 25%).

The amount of the PAYE cap for claims under both the merged scheme and ERIS is £20,000 plus 300% of the company’s relevant PAYE and National Insurance contributions liabilities.

The amount of the Pay As You Earn ("PAYE") cap for claims under both the merged scheme and ERIS is £20,000 plus 300% of the company’s relevant PAYE and National Insurance contributions liabilities.

The PAYE cap (where applicable) will limit the amount of payable credit that can be received in the accounting period under consideration.

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Based on prior claims and the split of qualifying spend it is expected that the PAYE cap is unlikely to affect the net benefit.

Furthermore, for accounting periods starting on or after April 1, 2024, legislation included in Finance Act 2024 restricts the extent to which payments to contractors for R&D, and externally provided workers can qualify for R&D relief where R&D activity takes place outside the U.K..

This may restrict the ability to include cost incurred on externally provided workers ("EPWs") based in the U.S.

and Switzerland for future accounting periods.

Furthermore, legislation included in Finance Act 2024 restricts the extent to which

payments to contractors for R&D and externally provided workers can qualify for R&D relief where R&D activity takes place outside the U.K., which may restrict the ability to include cost incurred on externally provided workers based in the U.S.

For 2024, we benefited from the applicable U.K.

research and development tax credit regime, being the Small and Medium-sized Enterprises R&D tax relief program ( “ SME Program ” ), and, to the extent that our projects are grant funded or relate to work subcontracted to us by third parties, the Research and Development Expenditure Credit program.

Under the SME Program, we were able to surrender some of our trading losses that arise from qualifying research and development activities for a cash rebate of up to 18.6% of such qualifying research and development expenditure, as the SME additional deduction is 86% and the SME credit rate is 10%.

Under both the merged RDEC scheme and the SME program, a company qualifies as an R&D intensive business if R&D expenditure constitutes at least 30% of total expenditure.

From the analysis performed, we have not and do not expect to claim under the loss-making R&D intensive scheme criteria primarily due to the proportion of total relevant expenditure occurring outside the U.K.

In future years, we may not be able to continue to claim research and development tax credits under the U.K.

research and development tax credit regime if we no longer qualify based on the eligibility criteria.

Unsurrendered U.K.

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taxable profits.

There was no tax loss restriction applied to the R&D tax credits in the U.K.

for the years ended December 31, 2025 and 2024.

Critical Accounting Policies and Use of Estimates

This discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP.

The preparation of financial statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue, income and expenses during the reporting period.

On an ongoing basis, management evaluates its estimates, including those related to fair value of contingent consideration and impairment of goodwill, intangible assets and other long-lived assets.

This discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with GAAP.

On an ongoing basis, management evaluates its estimates, including those related to fair value of contingent consideration and impairment of intangible assets.

Management bases its estimates on historical experience and on various other market specific and relevant assumptions that management believes to be reasonable under the circumstances.

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We believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our financial statements and understanding and evaluating our reported financial results.

We assess goodwill for impairment at least annually, or more frequently if events or changes in circumstances indicate that the carrying amounts may not be recoverable.

We have elected to assess goodwill for impairment by first performing a qualitative assessment to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount as a basis of determining whether it is necessary to perform the quantitative goodwill impairment test.

We have one reporting unit.

Accordingly, our review of goodwill impairment indicators is performed at the entity-wide level.

This requires us to assess and make judgments regarding a variety of factors, including clinical data results, business plans, anticipated future cash flows, economic projections and other market data.

Because there are inherent uncertainties involved in these factors, significant differences between these estimates and actual results could result in future impairment charges and could materially impact our future financial results.

We performed the annual impairment assessment and identified qualitative indicators of impairment due to, most notably, the share price drop in November 2024, including the lack of recovery thereof, and the strategic considerations to partner VTP-300 for future clinical development.

From the qualitative assessment performed, we determined it was more likely than not that the fair value of the reporting unit was less than its carrying amount.

Therefore, we performed a quantitative assessment using the income approach, which resulted in the recognition of an impairment charge of $12.2 million.

Long-lived Assets

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Intangible assets

We have identified circumstances that could indicate that the carrying amount of our intangible assets may not be recoverable, being a sustained decline in the price of our ADSs, whereby the market capitalization continues to be below the value of our net assets, and during 2024, the strategic expected use of the SNAP platform shifted from being a complementary platform to the viral vector platform to being solely used in the development of novel immunotherapeutic candidates for treating autoimmune and inflammatory diseases, and being called SNAP-TI (Tolerance Immunotherapy).

Therefore, we performed a quantitative impairment assessment using the income approach as of December 31, 2024, and determined that the carrying amount of the Company's intangible assets are recoverable, hence no impairment loss related to long-lived assets has been recognized.

Operating lease right-of-use asset and property and equipment

We have also identified circumstances that could indicate that the carrying amount of our operating lease right-of-use asset and property and equipment in the U.K.

asset group may not be recoverable as of December 31, 2024, as it was more likely than not that we would cease the operating activities undertaken in the laboratory and office space in Harwell, Oxfordshire in 2025, significantly before the end of the previously estimated useful life.

Therefore, we performed an impairment assessment as of December 31, 2024 and determined that the carrying amounts of our operating lease right-of-use assets and property and equipment in the U.K.

asset group were not fully recoverable, and impairment charges of $2.6 million related to the U.K.

operating lease right-of-use asset and $2.7 million related to the U.K.

property and equipment have been recognized.

These impairment charges are subject to a number of assumptions and actual results may differ.

We will continue to refine these assumptions as additional information becomes available.

In September 2025, we announced that we have entered into the Merger Agreement to combine in an all-stock transaction with Clywedog.

The indicative offer price was below the fair value of our net assets expected at completion and below prior valuations utilized in our most recent impairment assessments, thereby constituting an impairment triggering event.

As a result, we recorded a total impairment charge for acquired development technology intangible assets of $4.7 million during the quarter ended September 30, 2025.

The determination of the fair value of our net assets expected at completion, is a non-recurring fair value measurement.

Subsequently, we reviewed for additional indicators of impairment and did not identify any additional impairment triggers nor was any additional impairment expense recorded.

Contingent Consideration

We recognize a contingent consideration liability related to the acquisition of Avidea.

Avidea’s stockholders may be entitled to receive an aggregate of up to $40.0 million in additional payments, payable in a combination of cash and ADSs, upon the achievement of certain milestones.

The liability is remeasured to fair value at each reporting date until the contingency is resolved.

The fair value of the contingent consideration is a Level 3 valuation determined using significant unobservable inputs being the probability of success of achievement of the milestones and the expected date of the milestone achievement.

Avidea’s stockholders may be entitled to receive an

aggregate of up to $40.0 million in additional payments, payable in a combination of cash and ADSs, upon the achievement of certain milestones.

This contingent consideration is included within the purchase price and is recognized at its fair value on the acquisition date, and subsequently remeasured to fair value at each reporting date until the contingency is resolved.

The fair value of the contingent consideration is a Level 3 valuation determined using significant unobservable inputs, being the probability of pursuit of the activity associated with the milestone, the probability of success of the achievement of the milestone, the expected date of milestone achievement and applying the relevant discount rate.

Changes in fair value are recognized in general and administrative expenses in the consolidated statements of operations and comprehensive loss.

The fair value of contingent consideration is based on the probability of pursuit of the activity associated with the milestone, the probability of success of the achievement of the milestone, the expected date of milestone achievement and applying the relevant discount rate.

Results of Operations

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General and administrative 40,830 29,670 11,160

Impairment of intangible assets 4,667 — 4,667

Goodwill impairment — 12,209 (12,209)

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Net loss $ (66,458) $ (61,183) $ (5,275)

For the year ended December 31, 2024 and 2023, our revenue consisted of $15.0 million and $0.8 million, respectively from the OUI License Agreement Amendment with respect to amounts owed to us by OUI for the commercial sales of Vaxzevria.

The increase is due to the notification by OUI of additional commercial sales of Vaxzevria by AstraZeneca in prior periods.

For the year ended December 31, 2025 and 2024, our revenue consisted of nil and $15.0 million, respectively from the OUI License Agreement Amendment with respect to amounts owed to us by OUI for the commercial sales of Vaxzevria.

In 2024, AstraZeneca announced it had made the strategic decision to initiate the withdrawal of marketing authorization for Vaxzevria within Europe, citing decline in demand as the reason for the decision.

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VTP-1000 Celiac $ 6,063 $ 5,486 $ 577

$ 5,486 $ 8,420 $ (2,934)

VTP-300 HBV 10,474 11,276 (802)

VTP-850 Prostate cancer 1,429 2,726 (1,297)

VTP-200 HPV 2,009 4,950 (2,941)

VTP-600 NSCLC 2

473 597 (124)

VTP-500 MERS 3

Other and earlier stage programs 4

Barinthus legacy assets 1

8,531 18,223 (9,692)

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Total research and development expenses $ 25,564 $ 42,236 $ (16,672)

1 Research and development expenses related to VTP-1100 HPV Cancer were presented together with VTP-1000 Celiac in the prior period comparative, because our SNAP product candidates were both preclinical.

Expenses related to VTP-1100 HPV Cancer are now included in "Other and earlier stage programs," because we are deferring the planned IND application for VTP-1100 in HPV cancer and we have initiated the clinical trial for VTP-1000 Celiac.

2 The VTP-600 NSCLC/ESCC Phase 1/2a trial is sponsored by Cancer Research U.K.

3 The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).

4 This includes $0.9 million of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI.

1 In January 2025, we announced a strategic focus on developing a pipeline in I&I, and the deprioritization of our programs in infectious disease and oncology.

The following programs were previously presented separately and have been grouped collectively as "Barinthus Legacy Assets" for both years presented:

VTP-300 HBV, VTP-850 Prostate Cancer, VTP-200 HPV, VTP-600 NSCLC, VTP-500 MERS and other and earlier stage programs.

Our research and development expenses for the years ended December 31, 2025 and 2024 were $25.6 million and $42.2 million, respectively, and consisted of direct and indirect research and development expenses.

Direct expenses for the years ended December 31, 2025 and 2024 were $14.6 million and $23.7 million, respectively, and consisted of outside services, consultants, laboratory materials, clinical trials, manufacturing of clinical trial materials, as well as costs for external preclinical services and sample testing.

Of the $6.0 million decrease, a $2.9 million decrease pertains to the completion of the VTP-1000 preclinical studies and initiation of the Phase 1 AVALON clinical trial in the third quarter of 2024 and the deprioritization of VTP-1100 for HPV cancer announced earlier in 2024, a $2.9 million decrease pertains to a reduction in clinical trial and manufacturing development costs for the VTP-200 HPV program following the completion of the Phase 1b/2 APOLLO (HPV001) clinical trial in 2024, a $1.3 million decrease pertains to reduced activity following completion of enrollment of the VTP-850 Phase 1 clinical trial in October 2024 and a $0.8 million decrease pertains to VTP-300 HBV clinical trial and manufacturing costs as enrollment for the two ongoing Phase 2 trials is now complete.

These decreases were partially offset by an increase of $1.4 million mainly relating to increased investment in our SNAP-TI platform and related early stage programs, as well as VTP-1100 HPV cancer expenses now being included in Other and earlier stage programs.

Of the $9.1 million decrease, $9.7 million pertains to a net decrease in spend across Barinthus legacy asset infectious disease and oncology programs as the ongoing trials reached clinical completion and following the strategic decision to partner these programs for future development.

This decrease is partially offset by a $0.6 million increase in spend on VTP-1000 for the ongoing Phase 1 AVALON clinical trial.

Indirect research and development expenses for the years ended December 31, 2025 and 2024 were $11.0 million and $18.5 million, respectively.

Of the $3.4 million increase, $3.2 million relates to personnel-related expenses (including share-base compensation) primarily due to an average increase in headcount, severance cost of $1.0 million across our locations in the United Kingdom and United States following our announcement in June 2024 to prioritize our pipeline and more personnel time spent on research and development activities.

Of the $7.6 million decrease, $7.5 million relates to the reduction in headcount and the associated reduction in personnel-related expense (including share-based compensation).

General and Administrative Expenses

General and administrative expenses for the years ended December 31, 2025 and 2024 were $40.8 million and $29.7 million, respectively.

The decrease of $10.1 million relates primarily to a change in foreign exchange gains and losses of $10.2 million from a loss of $7.8 million for the year ended December 31, 2023 to a gain of $2.4 million for the year ended December 31, 2024, as well as a $3.0 million decrease in personnel costs due to the reduction in our general and administrative workforce in the second quarter of 2024, more personnel time spent on research and development activities and a reduction in share-based payment charges due to the timing of high value awards, a decrease in insurance costs of $1.7 million related to a reduction in insurance premiums and a decrease of $0.8 million in professional costs due to reduced activity compared to the prior period.

These decreases are partially offset by an increase in the expense recognized for the fair value measurement of contingent consideration of $0.8 million following an increase in the determined probability of success of achieving the associated milestones and an impairment charge of $5.3 million recognized in respect of our operating lease right-of-use assets and property and equipment in the U.K.

(see Notes 6 Property and Equipment, Net and 17 Commitments and Contingencies in the financial statements for further details).

The increase of $11.1 million relates primarily to a $12.0 million change in foreign exchange gains and losses (from a gain of $2.4 million for the year ended December 31, 2024 to a loss of $9.6 million for the year ended December 31, 2025), as well as an increase of $6.5 million in professional fees attributable to increased strategic activity.

These increases are partially offset by a $2.6 million net reduction in depreciation and amortization reflecting the $5.3 million impairment charge recorded in the year ended December 31, 2024 in relation to the U.K.

operating lease right-of-use assets and property and equipment.

For the year ended December 31, 2025, depreciation includes a $1.1 million impairment charge in relation to U.S.

right-of-use assets and leasehold improvements and $1.6 m accelerated depreciation due to a decrease in the estimated useful lives of the U.K.

right of use and fixed assets.

Personnel-related expenses decreased $2.8 million due to the reduction in headcount and the associated reduction in personnel-related expense (including share-based compensation).

Other general and administrative costs decreased $1.4 million which is attributable to reduced travel expenses, reduced communications expenses, lower insurance premiums and other reductions in facility-related expenses.

Impairment of intangible assets expense

For the years ended December 31, 2025 and 2024, impairment of intangible assets expense was $4.7 million and nil million, respectively.

This increase relates to the impairment assessment performed during the third quarter of 2025, following an impairment triggering event identified in relation to us entering a definitive merger agreement to combine in an all-stock merger transaction with Clywedog.

See Note 7 for further details.

Goodwill Impairment Expense

For the years ended December 31, 2024 and 2023, goodwill impairment expense was $12.2 million and nil, respectively.

The increase relates to the impairment assessment performed during the fourth quarter of 2024, based on the expected utilization of Company assets and external market conditions.

For the years ended December 31, 2025 and 2024, goodwill impairment expense was nil and $12.2 million, respectively.

The decrease relates to the impairment assessment performed during the fourth quarter of 2024, based on the expected utilization of Company assets and external market conditions.

Interest Income

For the years ended December 31, 2024 and 2023, interest income was $2.7 million and $2.9 million respectively, which primarily resulted from the interest earned on our short-term cash deposits and cash balances held by Barinthus Biotherapeutics (U.K.) Limited in United States dollars and pound sterling.

For the years ended December 31, 2025 and 2024, interest income was $2.0 million and $2.7 million respectively, which primarily resulted from the reduction in interest rates and the reduction in cash amounts on short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.

Research and Development Incentives

For the years ended December 31, 2024 and 2023, we accrued research and development incentives of $4.0 million and $3.5 million, respectively.

Such research and development incentives relate to corporation tax relief on research and development project incentive programs in the United Kingdom.

The increase of $0.5 million is primarily due to an increase in qualifying research and development activities following completion and submission of the 2023 claim.

For the years ended December 31, 2025 and 2024, research and development incentives were $2.0 million and $4.0 million, respectively.

Such research and development incentives relate to corporation tax relief on research and development project incentive programs in the U.K.

The decrease of $2.0 million is primarily due to a decrease in qualifying R&D activities related to the strategic decision to stop development of the viral vector programs beyond the completion of the ongoing clinical trials in the U.K.

and reduced R&D recovery rate under the new merged scheme for 2025.

For the years ended December 31, 2025 and 2024, the tax benefit was $0.18 million and $0.04 million respectively, which primarily relates to movements in deferred tax.

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Sources of Liquidity

Since our inception, we have funded our operations primarily through private and public placements of our ordinary and preferred shares as well as from grants and research incentives, various agreements with public funding agencies, the issuance of convertible loan notes and most recently from royalty and milestone payments from OUI in connection with the OUI License Agreement Amendment.

Through December 31, 2024, we had received gross proceeds of approximately $330.1 million from the issuance of our ordinary and preferred shares and convertible loan notes.

Since our inception, we have funded our operations primarily through private and public placements of our ordinary and preferred shares as well as from grants and research incentives, various agreements with public funding agencies, the issuance of convertible loan notes, and most recently from upfront royalty and milestone payments from OUI in connection with the OUI License Agreement Amendment for Vaxzevria.

Through December 31, 2025, we have received gross proceeds of approximately $330.1 million from the issuance of our ordinary and preferred shares and convertible loan notes.

As of December 31, 2025, we had cash, cash equivalents and restricted cash of $71.9 million.

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• In March 2021, we raised gross proceeds of $125.2 million from the issuance of our Series B shares.

• In May 2021, we raised gross proceeds of $110.5 million from the IPO of our ordinary shares on NASDAQ.

• Between April 2022 and September 2024, we received $59.5 million of cash from OUI for the commercial sales of Vaxzevria.

• Between December 2022 and December 31, 2024, we raised net proceeds of $5.1 million from the issuance of 2,558,586 shares represented by ADSs through “at-the-market” offerings under the sales agreement with Jefferies LLC.

On August 9, 2022, we filed the Shelf with the Securities and Exchange Commission in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million.

The Shelf was declared effective on August 17, 2022.

• In May 2021, we raised gross proceeds of $110.5 million from the initial public offering of our ordinary shares on Nasdaq.

• Between April 2022 and November 2024, we received $59.5 million of cash from OUI for the commercial sales of Vaxzevria.

We do not currently expect positive cash flows from operations in the foreseeable future, if at all.

In most periods, we have incurred operating losses as a result of ongoing efforts to develop our novel T cell immunotherapeutic candidates, including conducting ongoing research and development, preclinical studies, clinical trials, providing general and administrative support for these operations and developing our intellectual property portfolio.

We expect to continue to incur net negative cash flows from operations for at least the next few years as we progress clinical development, seek regulatory approval, prepare for and, if approved, proceed to manufacture and commercialization of our most advanced product candidates.

In most periods, we have incurred operating losses as a result of ongoing efforts to develop our immunotherapy platforms and our product candidates, including conducting ongoing research and development, preclinical studies, clinical trials, providing general and administrative support for these operations and developing our intellectual property portfolio.

product candidates.

Operating profits may arise earlier if programs are licensed or sold to third parties before final approval, but this cannot be guaranteed.

On September 29, 2025, we entered into the Merger Agreement providing for our combination with Clywedog.

We have agreed to various covenants and agreements, including, among others, agreements to conduct our business in the ordinary course of business between the execution of the Merger Agreement and the closing of the Combinations.

Outside of certain limited exceptions, we may not take certain actions without Clywedog’s consent, including (i) acquiring businesses and disposing of significant assets, (ii) incurring expenditures above specified thresholds;

(iii) incurring additional debt outside the ordinary course of business, (iv) issuing additional securities, or (v) repurchasing ordinary shares or ADSs.

The following table sets forth a summary of the primary sources and uses of cash (in thousands) for each period presented:

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Net cash used in operating activities $ (47,979) $ (28,940)

Net cash used in investing activities (892) (5,413)

Net cash provided by/(used in) investing activities

Net cash provided by financing activities

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Cash Used in Operating Activities

During the year ended December 31, 2025, net cash used in operating activities was $48.0 million, primarily resulting from our net loss of $66.5 million, adjusted by depreciation and amortization expense of $5.8 million, long-lived asset impairment charge of $5.8 million, unrealized foreign exchange loss of $3.7 million, non-cash lease expenses of $3.3 million, share based compensation of $0.5 million and changes in our operating assets and liabilities, net of $0.4 million primarily related to a $6.4 million decrease in research and development incentives receivable, a $6.0 million decrease in accounts payable and accrued expenses, a $2.0 million decrease in operating lease liabilities, a $1.7 million decrease in prepaid expenses, and a $0.5 million decrease in deferred income.

During the year ended December 31, 2024, net cash used in operating activities was $28.9 million, primarily resulting from our net loss of $61.2 million, adjusted by goodwill impairment expense of $12.2 million, depreciation and amortization of $5.8 million, an impairment charge of $5.3 million, share based compensation of $4.7 million, non-cash lease expenses of $1.4 million and changes in our operating assets and liabilities, net of $2.6 million primarily related to a $3.6 million decrease in prepaid expenses, a $1.8 million decrease in operating lease liabilities, a $1.7 million increase in deferred income, a $1.4 million increase in accounts payable and accrued expenses and a $2.3 million increase in research and development incentives receivable.

During the year ended December 31, 2023, net 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 benefit of $3.1 million and changes in our operating assets and liabilities, net decrease 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, a $3.4 million decrease in accounts payable and a $2.0 million increase in accrued expenses.

Net Cash Used in Investing Activities

During the year ended December 31, 2024, cash used in investing activities was $0.9 million primarily relating to lab and office equipment purchases in both our U.K.

During the year ended December 31, 2023, cash used in investing activities was $5.4 million primarily resulted from capital expenditures related to leasehold improvements on our new office in Germantown, Maryland, United States.

Net Cash Provided By / (Used In) Investing Activities

During the years ended December 31, 2025 and 2024, cash provided by/(used) in investing activities was $0.4 million and $(0.9) million, respectively.

For the year ended December 31, 2025, these amounts primarily related to proceeds received upon the sale of U.K.

laboratory equipment.

For the year ended December 31, 2024, these amounts primarily related to lab and office equipment purchases in both our U.K.

Net Cash Provided by Financing Activities

During the years ended December 31, 2024 and 2023, cash provided by financing activities was $2.2 million and $1.9 million, respectively, primarily resulting from the issuance of ordinary shares in the form of ADSs through the “at-the-market” sales agreement with Jefferies LLC.

Effect of exchange rates on cash and cash equivalents

During the years ended December 31, 2024 and 2023, the effect of foreign exchange on cash and cash equivalents was a $2.0 million loss and $2.2 million gain respectively, primarily as a result of fluctuations between the United States dollar and pound sterling exchange rates.

During the year ended December 31, 2025 cash provided by financing activities related only to net proceeds from the issuance of ordinary shares in the form of ADSs through stock option exercises.

During the year ended December 31, 2024, cash provided by financing activities of $2.2 million primarily related to net proceeds received from the issuance of ordinary shares in the form of ADSs through the “at-the-market” sales agreement with Jefferies LLC.

Effect of Exchange Rates on Cash, Cash Equivalents and Restricted Cash

During the years ended December 31, 2025 and 2024, the effect of foreign exchange on cash, cash equivalents and restricted cash was a $7.0 million gain and $2.0 million loss respectively, primarily as a result of fluctuations between the United States dollar and pound sterling exchange rates.

Future Funding Requirements

To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of our product candidates.

As a result, we have incurred losses in each year since our inception in 2016, through to December 31, 2021.

We were profitable in 2022, however we have negative operating cash flows for the periods ending December 31, 2024 and 2023.

As a result, we have incurred losses in each year since our inception in 2016, except for 2022 when we were profitable.

We have negative operating cash flows for the periods ending December 31, 2025 and 2024.

As of December 31, 2025, we had an accumulated deficit of $304.1 million.

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• attract, hire and retain additional clinical, regulatory, quality control and other personnel;

• conduct preclinical studies and clinical trials for our current and future product candidates based on our proprietary biologic and synthetic platforms, including the Chimpanzee Adenovirus Oxford ("ChAdOx") and Modified vaccinia Ankara ("MVA"), vectors, SNAP-TI, SNAP-CI and our other technologies;

• conduct preclinical studies and clinical trials for our current and future product candidates based on our proprietary synthetic and biologic platforms, including SNAP-TI;

• expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing and commercialization efforts and our operations as a public company;

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• incur additional legal, accounting and other expenses in operating our business, including the additional costs associated with operating as a public company;

• incur additional legal, advisory, accounting, tax and other expenses in operating our business, including the additional costs associated with completing the Contemplated Transactions.

Even if we succeed in commercializing one or more of our product candidates, we will continue to incur substantial research and development costs and other expenditures to develop and market additional product candidates and we may never generate revenue that is significant or large enough to achieve profitability.

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A decline in the value of our company also could cause you to lose all or part of your investment.

Since our foundation, we have invested a significant portion of our efforts and financial resources in research and development activities for our viral vector platform (ChAdOx and MVA), acquisition of additional complementary platforms such as SNAP-TI, development of new technologies in house, and our product candidates derived from these technologies.

Since our foundation, we have invested a significant portion of our efforts and financial resources in research and development activities for our viral vector platform (ChAdOx and MVA), acquisition of additional complementary platforms such as SNAP-TI, development of new technologies, and our product candidates derived from these technologies.

Preclinical studies and especially clinical trials and additional research and development activities will require substantial funds to complete.

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Our future capital requirements may depend on many factors, including:

• the timing, outcome and terms of the Contemplated Transactions currently in progress as well as associated transaction and advisory costs;

• the scope, progress, results and costs of researching and developing our current and future product candidates and programs, and of conducting preclinical studies and clinical trials;

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• the timing of, success achieved and the costs involved in obtaining regulatory and marketing approvals and developing our ability to establish license or sale transactions and/or sales and marketing capabilities, if any, for our current and future product candidates if clinical trials and approval processes are successful;

• the success of our collaborations with CEPI, Oxford University/OUI, Arbutus, CanSino, CRUK and the Ludwig Institute and any future collaboration partners;

• our ability to establish and maintain collaborations, strategic licensing or other arrangements and the financial terms of such agreements;

• the success of our collaborations with current and any future collaboration partners;

• our ability to establish, maintain or terminate collaborations, strategic licensing or other arrangements and the financial terms of such agreements;

• the costs of future commercialization activities, including product launch, product sales, marketing, manufacturing and distribution, for any of our current and future product candidates for which we receive marketing approval;

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Unless and until we can generate a substantial amount of revenue from our product candidates, we expect to finance our future cash needs through public or private equity offerings, debt financings, collaborations, licensing arrangements or other sources, or any combination of the foregoing.

These estimates are based on assumptions that may prove to be wrong, and we could use our available capital resources more quickly than we expect.

We may require substantial additional financing in the future to meet any such unanticipated factors.

We may require substantial additional financing in the future to meet any such unanticipated factors, including if the Contemplated Transactions are not consummated timely or at all.

If we raise additional funds through collaborations, strategic alliances, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us.

If we are unable to raise additional funds when needed, we would be required to delay, limit, reduce or terminate our product development programs, future commercialization efforts, other operational plans or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Other Obligations

Lease, Purchase, and Other Obligations

We have operating lease obligations related to our property, plant and equipment.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis