Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2023.
The term “disclosure controls and procedures”, means controls and other procedures of a company that are designed to provide reasonable assurance that the information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to provide reasonable assurance that the information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Based on our evaluation, our management, with the participation of our principal executive officer and principal financial officer, has concluded that, as of such date, that the previously reported material weaknesses have been remediated and our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Annual Report on Internal Control Over Financial Reporting
The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, and for the assessment of the effectiveness of internal control over financial reporting. The Company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP.
A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit the preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of the effectiveness of our internal controls in future periods are subject to the risk that such controls may become inadequate because of changes in conditions, or that the degree of compliance with applicable policies, processes and documentation requirements may deteriorate.
In making its assessment of the Company’s internal control over financial reporting as of December 31, 2023, management used the criteria set forth in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) and evaluated the internal control over financial reporting. Based on our assessment, management concluded that our internal control over financial reporting was effective as of December 31, 2023, based on criteria in Internal Control-Integrated Framework (2013) issued by the COSO.
Remediation of Previously Reported Material Weaknesses
As previously reported in our Form 10-K for the fiscal year ended December 31, 2022, and in our subsequent Form 10-Q reports for the periods ending March 31, June 30 and September 30, 2023, management identified material weaknesses in our internal control over financial reporting related to the following: (i) our IT general control environment had not been
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sufficiently designed to include appropriate user access rights, nor were controls over program development, program changes and computer operations designed, implemented and operating effectively, and (ii) policies and procedures with respect to the review, supervision and monitoring of our accounting and reporting functions were either not designed and in place or not operating effectively.
During fiscal years 2022 and 2023, we undertook efforts to remediate the previously disclosed material weaknesses. Our internal control remediation efforts focused on the areas detailed below.
(i) IT general controls environment
We took measures to address the IT environment and have implemented a new enterprise resource planning ("ERP") system, and completed the controls design and operation over program development, program changes, computer operations and access rights.
For the new ERP system and all other IT systems where material risks to financial reporting were identified, we implemented and tested the operating effectiveness of: (i) program change management controls to ensure that IT program and data changes affecting financial applications and underlying accounting records are identified, tested, authorized, and implemented appropriately; (ii) user access controls to ensure appropriate segregation of duties exist, to adequately restrict user and privileged access to certain financial applications, programs and data to appropriate company personnel; (iii) computer operations controls to ensure that critical batch jobs are monitored and data backups are authorized and monitored; (iv) testing and approval controls for program development to ensure that changes are aligned with business and IT requirements; and (v) identification and testing of system-generated information and calculations used in the execution of manual controls. In addition, we further developed and executed a testing protocol that allows us to validate the operating effectiveness of certain IT general controls to gain assurance that such controls are operating as designed.
(ii) policies and procedures with respect to the review, supervision and monitoring of our accounting and reporting functions
We took measures to address this material weakness, which included hiring appropriate personnel whose roles are to enhance policies and procedures with respect to the review, supervision, formalization and monitoring of our accounting and reporting functions. Additionally, we enhanced our business process controls through the following activities:
• evaluated and refined the design, implementation, and documentation of the internal controls to ensure controls address the relevant risks, are properly designed, and provide appropriate evidence of performance;
• enhanced the design of controls that address the completeness and accuracy of reports being utilized in the execution of internal controls;
• evaluated the assignment of responsibilities associated with the performance of control activities and hired additional resources, obtained third party assistance, and provided additional training to existing resources; and
• further developed and executed a testing protocol that allows us to validate the operating effectiveness of certain key controls over financial reporting and gain assurance that such controls are operating as designed.
Management has concluded that the actions taken to strengthen our internal control over financial reporting, as well as the results of our testing over the design and operating effectiveness of these controls, remediated the previously identified material weaknesses as of December 31, 2023.
Attestation Report of the Registered Public Accounting Firm
This Annual Report does not include an attestation report of our registered public accounting firm due to an exemption provided by the JOBS Act for “emerging growth companies.”
Changes in Internal Control over Financial Reporting
Other than the remediation activities related to the previously reported material weaknesses noted above, no other changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the year ended December 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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Item 9B. Other Information
(a)
None
(b)
None
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not Applicable.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance
The information required under this item is incorporated herein by reference and will be included in our definitive proxy statement for our 2024 Annual General Meeting to be filed with the U.S. Securities and Exchange Commission within 120 days of the end of our fiscal year.
We have adopted a Code of Conduct that applies to all officers, directors and employees in connection with their work for us. The full text of our Code of Conduct is posted on the investor relations page of our website at investors.barinthusbio.com/corporate-governance.
We intend to satisfy any disclosure requirements under Item 5.05 of Form 8-K regarding an amendment to, or waiver from, a provision of this Code of Conduct by posting such information on our website, at the Internet address and location specified above.
Item 11. Executive Compensation
The information required under this item is incorporated herein by reference and will be included in our definitive proxy statement for our 2024 Annual General Meeting to be filed with the United States Securities and Exchange Commission within 120 days of our fiscal year.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required under this item is incorporated herein by reference and will be included in our definitive proxy statement for our 2024 Annual General Meeting to be filed with the U.S. Securities and Exchange Commission within 120 days of the end of our fiscal year.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required under this item is incorporated herein by reference and will be included in our definitive proxy statement for our 2024 Annual General Meeting to be filed with the United States Securities and Exchange Commission within 120 days of the end of our fiscal year.
Item 14. Principal Accounting Fees and Services
The information required under this item is incorporated herein by reference and will be included in our definitive proxy statement for our 2024 Annual General Meeting to be filed with the United States. Securities and Exchange Commission within 120 days of the end of our fiscal year.
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PART IV
Item 15. Exhibits, Financial Statement Schedules
(a) The following documents are filed as part of this report:
(1) Financial Statements.
The financial statements filed as part of this report are listed on the Index to Consolidated Financial Statements in Item 8.
(2) Financial Statement Schedules.
No schedules are submitted because they are not applicable, not required, or because the information is included in the consolidated financial statements or the notes thereto.
(3) Exhibits.
EXHIBIT INDEX
Exhibits number Description of exhibit
2.1† Agreement and Plan of Merger and Reorganization, dated December 9, 2021, by and among Barinthus Biotherapeutics plc , VA Merger Sub 1 Inc., VA Merger Sub 2 Inc., Avidea Technologies Inc., and Benjamin Eisler, as the Securityholder Agent (Incorporated by reference to Exhibit 2.1 to our Periodic Report on Form 8-K (File No. 001-40367) filed on December 14, 2021).
2.2*† Amendment No. 1 to Agreement and Plan of Merger and Reorganization, dated March 11, 2022, by and between Barinthus Biotherapeutics plc and Benjamin Eisler, as Securityholder Agent (Incorporated by reference to Exhibit 2.2 to our Annual Report on Form 10-K (File No. 001-40367) filed on March 25, 2022).
2.3 Amendment No. 2 to Agreement and Plan of Merger and Reorganization, dated May 9, 2022, by and between Barinthus Biotherapeutics plc and Benjamin Eisler, as the Securityholder Agent (Incorporated herein by reference to Exhibit 2.1 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-40367), filed with the Securities and Exchange Commission on August 9, 2022).
3.2 Articles of Association of the Registrant (Incorporated by reference to Exhibit 3.1 to our Form 8-K (File No. 001-40367) filed on May 10, 2021)).
4.1 Form of Deposit Agreement (Incorporated by reference to Exhibit 4.1 to our Registration Statement on Form S-1/A (File No. 333-255158) filed on April 27, 2021).
4.2 Form of American Depositary Receipt (included in Exhibit 4.1).
4.3 Description of Registrant’s Securities (Incorporated by reference to Exhibit 4.3 to our Annual Report on Form 10-K (File No. 001-40367) filed on March 25, 2022).
10.1# EMI Option Scheme and form of award agreement thereunder (Incorporated by reference to Exhibit 10.1 to our Registration Statement on Form S-1/A (File No. 333-255158) filed on April 27, 2021).
10.2# 2021 Stock Option and Incentive Plan and forms of award agreements thereunder (Incorporated by reference to Exhibit 10.2 to our Registration Statement on Form S-1/A (File No. 333-255158) filed on April 27, 2021).
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10.3# 2021 Employee Share Purchase Plan (Incorporated by reference to Exhibit 10.17 to our Registration Statement on Form S-1/A (File No. 333-255158) filed on April 27, 2021).
10.4† License of Technology by and between the Registrant and Oxford University Innovation Limited, dated as of March 4, 2016, as amended on January 14, 2019 and as further amended April 29, 2020 (Incorporated by reference to Exhibit 10.3 to our Registration Statement on Form S-1/A (File No. 333-255158) filed on April 27, 2021).
10.5† License Agreement by and between the Registrant and Oxford University Innovation Limited, dated as of September 8, 2017 (Incorporated by reference to Exhibit 10.4 to our Registration Statement on Form S-1/A (File No. 333-255158) filed on April 27, 2021).
10.6† Master Collaboration Agreement by and between the Registrant and CanSino Biologics, Inc., dated as of September 4, 2018 (Incorporated by reference to Exhibit 10.5 to our Registration Statement on Form S-1/A (File No. 333-255158) filed on April 27, 2021).
10.9†
Clinical Trial and Option Agreement by and among Vaccitech Oncology Limited, Cancer Research Technology Limited, and Cancer Research UK, dated as of December 16, 2019 (Incorporated by reference to Exhibit 10.8 to our Registration Statement on Form S-1/A (File No. 333-255158) filed on April 27, 2021).
10.10#
Form of Deed of Indemnity between the Registrant and each of its directors and officers (Incorporated by reference to Exhibit 10.9 to our Registration Statement on Form S-1/A (File No. 333-255158) filed on April 27, 2021).
10.11#**
Form of Employment Agreement between the Registrant and William Enright (Incorporated by reference to Exhibit 10.10 to our Registration Statement on Form S-1/A (File No. 333-255158) filed on April 27, 2021).
10.12#**
Form of Employment Agreement between the Registrant and Graham Griffiths (Incorporated by reference to Exhibit 10.1 1 to our Registration Statement on Form S-1/A (File No. 333-255158) filed on April 27, 2021).
10.13 Registration Rights Agreement, dated March 28, 2022, by and among the Registrant and Benjamin Eisler, as the Securityholder Agent (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q (File No. 001-40367) filed on May 11, 2022).
10.14 Service Agreement with Gemma Brown, effective September 15, 2022 (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q (File No. 001-40367) filed on November 10, 2022).
10.15 Employment Agreement by and between Vaccitech Switzerland GmbH and Nadège Pelletier, effective February 1, 2023 (Incorporated by reference to Exhibit 10 .1 to our Q uarte rl y Report on From 10-Q (File No. 001-40367) filed on May 12, 2023).
10.16 Form of Indemnification Agreement between the Registrant and each of its directors and officers (Incorporated by reference to Exhibit 10.2 to our Quarterly Report on Form 10-Q (File No. 001-40367) filed on November 10, 2022).
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10.17 Lease Agreement dated September 3, 2021 by and among The Harwell Science and Innovation Campus General Partner Limited, The Harwell Science and Innovation Campus Nominee Limited, The Harwell Science and Innovation Campus Limited Partnership and Barinthus Biother ap eutics (UK) Limited (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q (File No. 001-40367) filed on November 12, 2021).
10.18*†
Funding Agreement by and between the Registrant , Coalition for Epidemic Preparedness Innovations and the University of Oxford , dated as of December 20 , 2023
21.1* Subsidiaries of the Registrant.
23.1* Consent of PricewaterhouseCoopers LLP, independent registered public accounting firm.
24.1* Power of Attorney (included on signature page to this Annual Report).
31.1* Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2* Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*+ Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97.0 Compensation Recovery Policy (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q (File No. 001-40367) filed on November 9, 2023).
101.INS* XBRL Instance Document
101.SCH* XBRL Taxonomy Extension Schema Document
101.CAL* XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF* XBRL Taxonomy Extension Definition Linkbase Document
101.LAB* XBRL Taxonomy Extension Label Linkbase Document
101.PRE* XBRL Taxonomy Extension Presentation Linkbase Document
104* Cover Page Interactive Data File (the cover page XBRL tags are embedded within the iXBRL document).
___________________________
* Filed or furnished herewith.
† Certain portions of this exhibit have been omitted because they are not material and the Registrant customarily and actually treats that information as private or confidential.
# Indicates a management contract or any compensatory plan, contract or arrangement.
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** Certain exhibits and schedules to these agreements have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Registrant will furnish copies of any of the exhibits and schedules to the Securities and Exchange Commission upon request.
+ The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to be furnished with this Annual Report and will not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
Item 16. Form 10-K Summary
Not Applicable.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
March 20, 2024 Barinthus Biotherapeutics plc
By: /s/ William Enright
William Enright
Chief Executive Officer
POWER OF ATTORNEY
Each person whose signature appears below constitutes and appoints William Enright and Gemma Brown, and each of them, as his or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or their or his or her substitutes, may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:
Signature Title Date
/s/ William Enright
Chief Executive Officer and Director March 20, 2024
William Enright (Principal Executive Officer)
/s/ Gemma Brown
Chief Financial Officer March 20, 2024
Gemma Brown (Principal Financial and Accounting Officer)
/s/ Robin Wright
Chairman and Director March 20, 2024
Robin Wright
/s/ Alex Hammacher
Director March 20, 2024
Alex Hammacher
/s/ Pierre A. Morgon
Director March 20, 2024
Pierre A. Morgon
/s/ Anne M. Phillips
Director March 20, 2024
Anne M. Phillips
/s/ Karen T. Dawes
Director March 20, 2024
Karen T. Dawes
/s/ Joseph C. F. Scheeren
Director March 20, 2024
Joseph C. F. Scheeren
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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm PricewaterhouseCoopers LLP (PCAOB ID 876 )
Consolidated Balance Sheets
F-1
Consolidated Statements of Operations and Comprehensive Loss
F- 2
Consolidated Statements of S tock holders’ Equity
F- 3
Consolidated Statements of Cash Flows
F- 5
Notes to Consolidated Financial Statements
F- 6
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Report of Independent Registered Public Accounting Firm
T o the Board of Directors and Shareholders of Barinthus Biotherapeutics plc
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Barinthus Biotherapeutics plc and its subsidiaries (the “Company”) as of December 31, 2023 and 2022, and the related consolidated statements of operations and comprehensive loss, consolidated statements of stockholders' equity, and consolidated statements of cash flows for the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers LLP
Reading, United Kingdom
March 20, 2024
We have served as the Company’s auditor since 2022.
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BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
As of
December 31,
2023 As of
December 31,
2022
ASSETS
Cash and cash equivalents $ 142,090 $ 194,385
Accounts receivable — 323
Accounts receivable – related parties — 5,524
Research and development incentives receivable 4,908 4,541
Prepaid expenses and other current assets 9,907 8,268
Total current assets 156,905 213,041
Goodwill 12,209 12,209
Property and equipment, net 11,821 7,957
Intangible assets, net 25,108 28,269
Right of use assets, net 7,581 7,753
Other assets 882 976
Total assets $ 214,506 $ 270,205
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 1,601 $ 3,748
Accrued expenses and other current liabilities 9,212 8,061
Operating lease liability - current 1,785 433
Total current liabilities 12,598 12,242
Non-Current liabilities:
Operating lease liability - non-current 11,191 8,340
Contingent consideration 1,823 1,711
Other non-current liabilities 1,325 965
Deferred tax liability, net 574 3,746
Total liabilities $ 27,511 $ 27,004
Commitments and contingencies (Note 16)
Stockholders’ equity:
Ordinary shares, £ 0.000025 nominal value; 38,643,540 shares authorized, issued and outstanding (December 31, 2022: authorized, issued and outstanding: 37,683,531 )
1 1
Deferred A shares, £ 1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2022: authorized, issued and outstanding: 63,443 )
86 86
Deferred B shares, £ 0.01 nominal value; 0 shares authorized, issued and outstanding (December 31, 2022: authorized, issued and outstanding: 570,987 )
— 8
Deferred C shares, £ 0.000007 nominal value, 0 shares authorized, issued and outstanding (December 31, 2022: authorized, issued and outstanding: 27,828,231 )
— 0 1
Additional paid-in capital 386,602 379,504
Accumulated deficit ( 176,590 ) ( 103,243 )
Accumulated other comprehensive loss – foreign currency translation adjustments ( 23,315 ) ( 33,460 )
Total stockholders’ equity attributable to Barinthus Biotherapeutics plc shareholders 186,784 242,896
Noncontrolling interest 211 305
Total stockholders’ equity $ 186,995 $ 243,201
Total liabilities and stockholders’ equity $ 214,506 $ 270,205
___________________________
1 Indicates amount less than one thousand
The accompanying notes are an integral part of these consolidated financial statements.
F-1
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BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
Year Ended
December 31, 2023 December 31, 2022
License revenue 1
$ 802 $ 44,694
Research grants and contracts — 9
Total revenue 802 44,703
Operating expenses
Research and development 44,874 42,350
General and administrative 39,842 6,394
Total operating expenses 84,716 48,744
Loss from operations ( 83,914 ) ( 4,041 )
Other income /(expense):
Interest income 2,877 3,103
Interest expense ( 28 ) ( 19 )
Research and development incentives 3,461 1,240
Other income, net 1,082 567
Total other income, net 7,392 4,891
(Loss)/profit before income tax ( 76,522 ) 850
Tax benefit 3,075 4,471
Net (loss)/income ( 73,447 ) 5,321
Net loss attributable to noncontrolling interest 100 21
Net (loss)/income attributable to Barinthus Biotherapeutics plc shareholders ( 73,347 ) 5,342
Weighted-average ordinary shares outstanding, basic 38,386,491 37,248,126
Weighted-average ordinary shares outstanding, diluted 38,386,491 38,169,307
Net (loss)/income per share attributable to ordinary shareholders, basic $ ( 1.91 ) $ 0.14
Net (loss)/income per share attributable to ordinary shareholders, diluted $ ( 1.91 ) $ 0.14
Net (loss)/income $ ( 73,447 ) $ 5,321
Other comprehensive gain/(loss) – foreign currency translation adjustments 10,151 ( 25,083 )
Comprehensive loss ( 63,296 ) ( 19,762 )
Comprehensive loss attributable to noncontrolling interest 94 132
Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders $ ( 63,202 ) $ ( 19,630 )
___________________________
1 Includes license revenue from related parties for the year ended December 31, 2023 totaling $ 0.8 million (December 31, 2022: $ 43.7 million). License revenue is generated in the United Kingdom.
The accompanying notes are an integral part of these consolidated financial statements.
F-2
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BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(IN THOUSANDS, EXCEPT NUMBER OF SHARES)
Year ended December 31, 2023
Ordinary Shares Deferred A Shares Deferred B Shares Deferred C Shares Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive Loss Total stockholders’ equity attributable to Barinthus Biotherapeutics plc stockholders Non-Controlling Interest Total Stockholders' Equity
Shares Amount Shares Amount Shares Amount Shares Amount
Balance, January 1,2023 37,683,531 $ 1 63,443 $ 86 570,987 $ 8 27,828,231 $ 0 1 $ 379,504 $ ( 103,243 ) $ ( 33,460 ) $ 242,896 $ 305 $ 243,201
Share based compensation — — — — — — — — 5,055 — — 5,055 — 5,055
Issue of ordinary shares, net of issuance costs 960,009 0 1 — — — — — — 2,035 — — 2,035 — 2,035
Foreign currency translation adjustments — — — — — — — — — — 10,145 10,145 6 10,151
Cancellation of deferred shares — — — — ( 570,987 ) ( 8 ) ( 27,828,231 ) — 8 — — — — —
Net loss — — — — — — — — — ( 73,347 ) — ( 73,347 ) ( 100 ) ( 73,447 )
Balance, December 31,2023 38,643,540 $ 1 63,443 $ 86 — $ — — $ 0 1 $ 386,602 $ ( 176,590 ) $ ( 23,315 ) $ 186,784 $ 211 $ 186,995
___________________________
1 Indicates amount less than one thousand
The accompanying notes are an integral part of these consolidated financial statements.
F-3
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BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(IN THOUSANDS, EXCEPT NUMBER OF SHARES)
Year ended December 31, 2022
Ordinary Shares Deferred A Shares Deferred B Shares Deferred C Shares
Shares Amount Shares Amount Shares Amount Shares Amount Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive Loss Total stockholders’ equity attributable to Barinthus Biotherapeutics plc stockholders Non-Controlling Interest Total Stockholders' Equity
Balance, January 1,2022 37,188,730 $ 1 63,443 $ 86 570,987 $ 8 27,828,231 0 1 $ 369,103 $ ( 108,585 ) $ ( 8,488 ) $ 252,125 $ 437 $ 252,562
Share based compensation — — — — — — — — 9,877 — — 9,877 — 9,877
Issue of ordinary shares, net of issuance costs 494,801 0 1 — — — — — — 484 — — 484 — 484
Foreign currency translation adjustments — — — — — — — — — — ( 24,972 ) ( 24,972 ) ( 111 ) ( 25,083 )
Measurement period and contingent consideration adjustments — — — — — — — — 40 — — 40 — 40
Net loss — — — — — — — — — 5,342 — 5,342 ( 21 ) 5,321
Balance, December 31,2022 37,683,531 $ 1 63,443 $ 86 570,987 $ 8 27,828,231 $ 0 1 $ 379,504 $ ( 103,243 ) $ ( 33,460 ) $ 242,896 $ 305 $ 243,201
___________________________
1 Indicates amount less than one thousand
The accompanying notes are an integral part of these consolidated financial statements.
F-4
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BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS)
December 31,
2023 December 31,
2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net (loss)/income $ ( 73,447 ) $ 5,321
Adjustments to reconcile net (loss)/income to net cash used in operating activities:
Share based compensation 5,055 9,877
Depreciation and amortization 5,429 4,323
Non-cash lease expenses 1,328 1,216
Unrealized foreign exchange loss/(gain) 7,531 ( 24,905 )
Change in contingent consideration 55 ( 73 )
Non cash interest expense 28 19
Deferred tax expense ( 3,075 ) ( 4,337 )
Profit on sale of property and equipment — ( 348 )
Changes in operating assets and liabilities:
Accounts receivable (including related parties) 5,800 ( 5,833 )
Prepaid expenses and other current assets 2,200 ( 2,170 )
Research and development incentives receivable ( 127 ) 1,158
Accounts payable ( 3,378 ) 1,140
Accrued expenses and other current liabilities 1,993 751
Deferred revenue — ( 183 )
Operating lease liabilities ( 445 ) —
Other assets 128 ( 387 )
Net cash used in operating activities $ ( 50,925 ) $ ( 14,431 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sale of property and equipment — 388
Purchases of property and equipment ( 5,413 ) ( 6,138 )
Net cash used in investing activities $ ( 5,413 ) $ ( 5,750 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Issue of shares from the exercise of stock options 0 1
0 1
Proceeds from issue of ordinary shares, net of issuance costs 2,035 484
Payment of contingent consideration ( 163 ) —
Repayment of debt — ( 159 )
Net cash provided by financing activities $ 1,872 $ 325
Effect of exchange rates on cash and cash equivalents 2,171 187
Net decrease in cash and cash equivalents ( 52,295 ) ( 19,669 )
Cash and cash equivalents, beginning of the year 194,385 214,054
Cash and cash equivalents, end of the year $ 142,090 $ 194,385
Supplemental cash flow disclosures:
Cash paid for interest $ — $ 0 1
Cash paid for income taxes $ — $ 0 1
Non-Cash investing and financing activities
Purchases of property and equipment included in accounts payable and accrued liabilities $ 87 $ 559
ROU assets obtained in exchange for operating lease liabilities $ — $ 2,400
Asset retirement obligation $ 287 $ 999
Changes to right-of-use asset resulting from lease reassessment event $ 88 $ ( 207 )
Measurement period adjustments $ — $ ( 38 )
Contingent Consideration settled in equity $ — $ 78
___________________________
1 Indicates amount less than one thousand
The accompanying notes are an integral part of these consolidated financial statements.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Nature of Business and Basis of Presentation
Nature of business
Barinthus Biotherapeutics plc (formerly Vaccitech plc) is a public limited company incorporated pursuant to the laws of England and Wales in March 2021. Barinthus Biotherapeutics plc and its direct and indirect subsidiaries, Barinthus Biotherapeutics (UK) Limited (formerly Vaccitech (UK) Limited), Barinthus Biotherapeutics Australia Pty Limited (formerly Vaccitech Australia Pty Limited), Vaccitech Oncology Limited (“VOLT”), Barinthus Biotherapeutics North America, Inc. (formerly Vaccitech North America, Inc.), Barinthus Biotherapeutics Switzerland GmbH (formerly Vaccitech Switzerland GmbH) and Barinthus Biotherapeutics S.R.L. (formerly Vaccitech Italia S.R.L.), are collectively referred to as the “Company” or “Barinthus Bio”. The Company 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. The Company is headquartered in Harwell, Oxfordshire, United Kingdom. On November 6, 2023, the Company announced its renaming as Barinthus Bio to represent the evolution and expansion of its focus beyond vaccines.
In connection with the initial public offering of American Depositary Shares (“ADSs”), in March 2021, the Company completed a corporate reorganization wherein the shareholders of Barinthus Biotherapeutics (UK) Limited exchanged each of their ordinary shares, series A shares and series B shares of Barinthus Biotherapeutics (UK) Limited for the same quantity of ordinary shares, series A shares and series B shares in Barinthus Biotherapeutics plc (resulting in the shareholders of the Company holding the same percentage and class of shares in Barinthus Biotherapeutics plc as they had in Barinthus Biotherapeutics (UK) Limited). The group reorganization under common control constituted a change in reporting entity and has been given retrospective effect reflecting the net assets of Barinthus Biotherapeutics (UK) Limited and its subsidiaries and Barinthus Biotherapeutics plc at their historical carrying amounts. On April 4, 2022, a merger was effected between subsidiaries Vaccitech USA, Inc. and Barinthus Biotherapeutics North America, Inc., with Barinthus Biotherapeutics North America, Inc. being the surviving entity.
The Company operates in an environment of rapid technological change and substantial competition from pharmaceutical and biotechnology companies. The Company is subject to risks common to companies in the biopharmaceutical industry in a similar stage of its life cycle including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its vaccine product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of any of its products that are approved, and protection of proprietary technology. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain required regulatory approval or that any approved products will be commercially viable. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will generate significant product sales. If the Company does not successfully commercialize any of its products or mitigate any of these other risks, it will be unable to generate revenue or achieve profitability.
Basis of presentation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission for annual financial reporting. The Company’s reporting currency is the U.S. dollar.
As of December 31, 2023, the Company had cash and cash equivalents of $ 142.1 million and an accumulated deficit of $ 176.6 million and the Company expects to incur losses for the foreseeable future. The Company expects that its cash and cash equivalents will be sufficient to fund current operations into the fourth quarter of 2025, without additional financing. The Company expects to seek additional funding through equity financing, government or private-party grants, debt financings or other capital sources, including collaborations with other companies or other strategic transactions. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into collaborations or other arrangements. The terms of any financing may adversely affect the holdings or rights of the Company’s stockholders. If the Company is unable to obtain sufficient capital, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, among other things, the realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business.
Guarantees and indemnifications
As permitted under the laws of England and Wales, the Company indemnifies its officers, directors, consultants and employees for certain events or occurrences that happen by reason of the relationship with, or position held at, the Company. Through the years ended December 31, 2023 and 2022, the Company had not experienced any losses related to these indemnification obligations, and no claims were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established.
Use of estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue, income and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis, including those related to fair value of contingent consideration and impairment of goodwill and intangible assets. The Company’s actual results may differ from these estimates under different assumptions or conditions.
As of the date of issuance of these consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements.
2. Summary of Significant Accounting Policies
Principles of consolidation
The accompanying consolidated financial statements include the accounts of Barinthus Biotherapeutics plc and those entities in which it has a controlling interest. Intercompany amounts are eliminated on consolidation. Amounts attributable to the noncontrolling interest are presented as a separate element of equity in the accompanying consolidated financial statements.
Comprehensive loss
Comprehensive loss for all periods presented is comprised primarily of net (loss)/income and other comprehensive loss, which solely relates to foreign currency translation adjustments.
Foreign currency translation
The Company’s reporting currency is the United States dollar. The functional currency of the parent and each subsidiary is the currency of the country and economic environment in which it is located. Assets and liabilities of each legal entity denominated or measured in a currency other than British Pounds are first translated into British pounds and consolidated. The consolidated balances are then converted into United States dollars at period-end exchange rates. Revenues and expenses are translated into British pounds, then into U.S. dollars at average exchange rates for each reporting period. Translation adjustments are reflected as accumulated other comprehensive loss within stockholders’ equity. Gains and losses on foreign currency transactions are included in the consolidated statements of operations and comprehensive loss in the general and administrative expenses. The aggregate net foreign exchange gain or loss included in determining net loss was a loss of $ 7.6 million and gain of $ 26.4 million for the years ended December 31, 2023 and 2022, respectively.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Segment information
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, the Company’s Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment, the research and development of immunotherapies and vaccines.
Noncontrolling interest
In 2018, Barinthus Biotherapeutics plc established VOLT with a related party. As of December 31, 2021, Barinthus Biotherapeutics plc had contributed cash and intellectual property with an aggregate value of $ 11.9 million for a 76 % controlling interest. The related party had contributed cash and intellectual property with an aggregate value of $ 3.8 million for a 24 % noncontrolling interest. There were no further contributions in the years ended December 31, 2023 and 2022. The contributed intellectual properties were initially recorded at investment date fair value by VOLT and immediately expensed as research and development costs. The Company accounts for the noncontrolling interest in the accompanying consolidated financial statements initially at fair value with the subsequent carrying value adjusted for the noncontrolling share of VOLT’s comprehensive loss.
Business Combinations
The Company accounts for business combinations using the acquisition method of accounting, which requires the recognition of tangible and identifiable intangible assets acquired and liabilities assumed at their estimated fair values as of the business combination date. The Company allocates any excess purchase price over the estimated fair value assigned to the net tangible and identifiable intangible assets acquired and liabilities assumed to goodwill. Contingent consideration is included within the acquisition cost and is recognized at its fair value on the acquisition date. A liability resulting from contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved and changes in fair value are recognized in general and administrative expenses in the consolidated statements of operations and comprehensive loss. Transaction costs are expensed as incurred in general and administrative expenses. Results of operations and cash flows of acquired companies are included in the Company’s operating results from the date of acquisition.
Cash and cash equivalents
The Company considers all highly liquid investments purchased with remaining maturities of three months or less on the purchase date to be cash and cash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that are actively traded (a Level 1 input). As of December 31, 2023, and 2022 there were no cash equivalents.
Revenue
The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services.
The Company has entered into collaboration and license agreements, which are within the scope of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers , to discover, develop, manufacture and commercialize product candidates. The terms of these agreements typically contain multiple promises or obligations, which may include licenses, or options to obtain licenses, to product candidates or future product candidates. The Company also derives revenue from government grants.
Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying consolidated balance sheets. Amounts recognized as revenue, but not yet received or invoiced are generally recognized as accounts receivable.
License revenue
The Company’s arrangements may provide the collaboration partner with the right to select a target for licensing either at the inception of the arrangement or in the future. Under these arrangements, fees may be due to the Company (i) at the inception of the arrangement as an upfront fee or payment, (ii) upon the exercise of an option to acquire a license or (iii)
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
upon extending the selection period as an extension fee or payment. If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. The Company evaluates the customer options for material rights, or options to acquire additional goods or services for fee or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the inception of the arrangement. The Company allocates the transaction price to material rights based on the relative standalone selling price, which is determined based on the identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised or expires.
For arrangements that include sales-based milestones and royalties, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). This could require management to estimate the amount of revenue to recognize in the period if the actual data for the period has not been provided.
Research and development services
The promises under the Company’s collaboration and license agreements generally include research and development services to be performed by the Company on behalf of the collaboration partner. For performance obligations that include research and development services, the Company recognizes revenue allocated to such performance obligations based on an appropriate measure of progress. The Company utilizes judgment to determine the appropriate method of measuring progress for the purposes of recognizing revenue, which may include an input measure such as costs incurred during the reporting period or ratably over the service period. Reimbursements from the partner are evaluated as to whether the Company acts as a principal or an agent in such relationships. The Company evaluates whether control over the underlying goods or services were obtained prior to transferring these goods or services to the collaboration partner. Where the Company does not control the goods or services prior to transferring these goods or services to the collaboration partner, such reimbursements are presented net of costs. At the inception of each arrangement that includes development milestone payments in respect of development efforts, the Company evaluates whether the development milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated development milestone value is included in the transaction price. Development milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular development milestone in making this assessment. There is judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each reporting period, the Company reevaluates the probability of achievement of all development milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. If a milestone or other variable consideration relates specifically to the Company’s efforts to satisfy a single performance obligation or to a specific outcome from satisfying the performance obligation, the Company generally allocates the milestone amount entirely to that performance obligation once it is probable that a significant revenue reversal would not occur. To date, the Company has not recognized any development milestone revenue resulting from any of its arrangements.
Grant income
The Company receives certain grant income which support its research efforts in defined projects and include contributions towards the research and development costs. When there is reasonable assurance that the Company 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 the Company recognizes expenses for the related costs for which the grants are intended to compensate. Grant income may be subject to review by the grantor in periods subsequent to its recognition and may result in the reversal of grant income previously recognized. Payments received in advance of incurring reimbursable expenses are recorded as deferred income.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Concentrations of credit risk
Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents and accounts receivable. Periodically, the Company maintains deposits in financial institutions in excess of government insured limits. Management believes that the Company is not exposed to significant credit risk as the Company’s deposits are held at financial institutions that management believes to be of high credit quality and the Company has not experienced any losses in these deposits. The Company’s standard payment terms are 30 days’.
The Company recognizes revenue earned in connection with the license and services provided to customers and grantors. The Company provides credit to the grantors in the normal course of providing such services based on evaluations of their financial condition and generally does not require collateral. To manage accounts receivable credit risk, the Company monitors the creditworthiness of its grantors. Historically, the Company has not experienced any credit losses related to accounts receivable and does not maintain allowances for uncollectible amounts.
Licensees and grantors that represented 10% of more of the Company’s revenue and accounted for 10% or more of accounts receivable are presented below:
Revenue Country Year ended
December 31,
2023 Year ended
December 31,
2022
Oxford University Innovation U.K. 100 % 98 %
Accounts Receivable Country As of
December 31,
2023 As of
December 31,
2022
Oxford University Innovation U.K. — % 94 %
Allowance for credit losses
The Company evaluates its cash equivalents and accounts receivable for expected credit losses. Expected credit losses represent the portion of the amortized cost basis of a financial asset that an entity does not expect to collect. An allowance for expected credit losses is meant to reflect a risk of loss even if remote, irrespective of the expectation of collection from a particular issuer or debt security. The Company has not historically experienced any credit losses on any of its financial assets. With respect to cash equivalents and accounts receivable, given consideration of their short maturity, historical losses and the current market environment, the Company concluded there are no expected credit losses for these financial assets.
Property and equipment
Property and equipment are stated at cost, net of accumulated depreciation. Expenditures for maintenance and repairs are charged to operating expenses as incurred, whereas major betterments are capitalized as additions to property and equipment. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets as follows:
Asset Category Estimated Useful Life
Office furniture and equipment 3 years
Laboratory equipment 4 years
Leasehold improvements Lesser of lease term or estimated useful lives
Intangible assets acquired through business combinations
Intangible assets consist of acquired developed technology. Intangible assets are stated at cost less accumulated amortization and impairment losses. Amortization is computed using the straight-line method over the estimated useful lives of the respective assets, which is 10 years.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Impairment of long-lived assets
The Company reviews long-lived assets to be held and used, including property and equipment, intangible assets and operating lease right-of-use assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable. Evaluation of recoverability is first based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset group and its eventual disposition. In the event such cash flows are not expected to be sufficient to recover the carrying amount of the asset or asset group, the assets are written down to their estimated fair values. No such impairments were recorded during the years ended December 31, 2023 and 2022.
Goodwill
Goodwill represents the excess of cost over the fair value of the net tangible and intangible assets of businesses acquired in a business combination. Goodwill is not amortized but rather is tested for impairment at least annually, or more frequently if events or changes in circumstances indicate that the carrying amount of goodwill may not be recoverable. The Company has elected to first assess the qualitative factors 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. If the Company determines that it is more likely than not that its fair value is less than its carrying amount, then the quantitative goodwill impairment test will be performed. The quantitative goodwill impairment test identifies goodwill impairment and measures the amount of goodwill impairment loss to be recognized by comparing the fair value of a reporting unit with its carrying amount. If the fair value exceeds the carrying amount, no further analysis is required; otherwise, any excess of the goodwill carrying amount over the implied fair value is recognized as an impairment loss, and the carrying value of goodwill is written down to fair value. For the years ended December 31, 2023 and 2022, goodwill has been tested, and no impairments have been recorded.
Financial instruments
The Company’s financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable, certain accrued expenses, contingent consideration and short-term debt. The carrying amounts of cash, cash equivalents, accounts receivable, security deposits, accounts payable, accrued expenses and short-term debt approximate their fair value due to the short-term nature of those financial instruments.
Fair value measurements
The Company follows the guidance in ASC 820, Fair Value Measurements and Disclosures , which defines fair value and establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below:
- Level 1 – Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.
- Level 2 – Valuations based on quoted prices in markets that are not active or for which all significant inputs are observable, either directly or indirectly.
- Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
Fair value is a market-based measure considered from the perspective of a market participant rather than an entity-specific measure. Therefore, even when market assumptions are not readily available, the Company’s own assumptions are set to reflect those that market participants would use in pricing the asset or liability at the measurement date. The Company uses prices and inputs that are current as of the measurement date, including during periods of market dislocation. In periods of market dislocation, the observability of prices and inputs may change for many instruments. This condition could cause an
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
instrument to be reclassified within levels in the fair value hierarchy. There were no transfers within the fair value hierarchy during the years ended December 31, 2023 and 2022.
The Company recognizes a contingent consideration liability related to the acquisition of Avidea Technologies, Inc. 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. Changes in fair value are recognized in general and administrative expenses in the consolidated statements of operations and comprehensive loss.
Leases
Leases are accounted for under ASC 842, Leases (“ASC 842”) resulting in the recognition of lease liabilities and right-of-use assets. The Company only has operating leases. The Company has elected the practical expedient allowed under ASC 842 to account for each lease component (e.g., the right to use office space) and the associated non-lease components (e.g., maintenance services) as a single lease component. The Company also elected the short-term lease accounting policy for all asset classes; therefore, the Company is not recognizing a lease liability or right-of-use asset for any lease that, at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the Company is reasonably certain to exercise.
Variable lease payments such as the Company’s share of real estate taxes, utilities, and common area maintenance, are reported as non-lease operating expenses.
Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. As the Company’s leases typically do not provide an implicit rate, the Company uses an estimate of its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments.
Right-of-use assets also include the effect of any lease payments made and exclude lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized as part of total operating expenses on a straight-line basis over the lease term. The difference between the value of the right of use asset and lease liability is due to the reclassification of prepaid rent and unamortized lease incentives.
Research and development
Research and development costs are expensed as incurred on an accruals basis. Research and development costs include payroll and personnel expense (including share-based compensation), consulting costs, external contract research and development expenses, raw materials, drug product manufacturing costs, and allocated overheads including depreciation and amortization, facility costs, and utilities. Research and development costs that are paid in advance of performance are capitalized as a prepaid expense and amortized over the service period as the services are provided.
Clinical trial costs
Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activation, and other information provided to the Company by its vendors.
Patent and licensing costs
Patent and licensing costs are expensed as incurred because their realization is uncertain.
Ordinary shares
Ordinary shares are classified in stockholders’ equity and represent issued share capital.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Additional paid-in capital
Additional paid-in capital is classified in stockholders’ equity and represents the share premium account, where the difference between the price paid per share and the nominal value is recognized. The equity element of share based compensation is also recognized in additional paid in capital.
Share based compensation
The Company grants options over ordinary shares and restricted shares units to employees or Non-Executive Directors and accounts for share based compensation using the grant date fair value. Share based compensation awards are classified in the accompanying statements of operations based on the function to which the related services are provided. For service-based awards, compensation expense is generally recognized over the requisite service period of the awards, usually the vesting period. The Company applies the “multiple option” method of allocating expense. In applying this method, each vesting tranche of an award is treated as a separate grant and recognized on a straight-line basis over that tranche’s vesting period. For performance-based awards where the vesting of the awards may be accelerated upon the achievement of certain milestones, vesting and the related share-based compensation is recognized as an expense when it is probable the milestone will be met. Assumptions used in the option pricing model include the following:
Expected volatility. Previously there was insufficient trading history for the Company’s ordinary shares, therefore the expected price volatility for our ordinary shares was estimated using the average historical volatility of industry peers’ shares as of the grant date of our options over a period of history commensurate with the expected life of the options. When selecting industry peers used in measuring implied volatility, the Company considered the similarity of their products and business lines, as well as their stage of development, size and financial leverage. The Company applied this process consistently using the same or similar public companies until 2023. During 2023, the Company determined that there is sufficient historical information on volatility of its share price available and the expected volatility used in the fair value calculation of new option grants is calculated based on a blended volatility of both historical volatility of the Company's share price and the expected volatility of the average historical volatility of industry peers’ shares.
Expected term . The expected term of the Company’s share options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The “simplified” method was determined to be appropriate as the Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term due to the limited period of time its equity shares have been publicly traded.
Risk-free interest rate . The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods that are approximately equal to the expected term of the award.
Expected dividend. Expected dividend yield of zero is based on the fact that the Company has never paid cash dividends on ordinary shares and does not expect to pay any cash dividends in the foreseeable future.
The Company has elected to recognize the effect of forfeitures on share-based compensation when they occur. Any differences in compensation recognized at the time of forfeiture are recorded as a cumulative adjustment in the period where the forfeiture occurs.
When awards are modified, the Company compares the fair value of the affected award measured immediately prior to modification to its value after modification. To the extent that the fair value of the modified award exceeds the original award, the incremental fair value of the modified award is recognized as compensation on the date of modification for vested awards, and over the remaining vesting period for unvested awards.
Income taxes
The financial statements reflect provisions for income taxes in the United Kingdom and foreign jurisdictions. Deferred tax assets and liabilities represent future tax consequences of temporary differences between the financial statement carrying amounts and the tax basis of assets and liabilities and for loss carryforwards using enacted tax rates expected to be in effect in the years in which the differences reverse. A valuation allowance is recorded when it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. To date, the Company has not incurred interest and penalties related to uncertain tax positions nor has it recorded any unrecognized tax benefits.
Research and development incentives
In the United Kingdom, the Company had previously been entitled to a 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. Until March 2023, under the SME program, the Company was able to surrender some of its trading losses that arise from qualifying research and development activities for a cash rebate of up to 33.35% of such qualifying research and development expenditure. Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects. Certain staff, consumables (including utilities), subcontractors and externally provided workers qualifying research and development expenditures are eligible for a cash rebate of up to 21.67%. 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 April 2023, under the SME program the additional deduction has decreased from 130% to 86%, the SME credit rate has reduced from 14.5% to 10% and the SME cash rebate for the Company has reduced from 33.35% to 18.6% and from 21.67% to 12.1% for subcontractors. Furthermore, the SME credit rate will decrease to 10% for expenditure incurred on or after April 1, 2023 unless the SME qualifies as an R&D intensive business i.e., 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. If the Company incurs tax losses, the Company is entitled to surrender the lesser of unrelieved tax loss sustained and the tax relief. As the realization of the tax relief does not depend on our generation of future taxable income or the Company’s ongoing tax status or tax position, the Company does not consider the tax relief as an element of income tax accounting under ASC 740, Income taxes and records the tax relief as a form of government grant or assistance. For the years ended December 31, 2023 and 2022, the Company recognized research and development incentives of $ 3.5 million and $ 1.2 million respectively.
Net (loss)/income per share
Basic net (loss)/income per share is computed by dividing the net (loss)/income attributable to ordinary shareholders by the weighted-average number of ordinary shares outstanding for the reporting period without consideration for potentially dilutive securities. Net (loss)/income attributable to ordinary shareholders is computed as if all net (loss)/income for the period had been distributed. During periods in which the Company incurred a net loss, the Company allocates no net loss to participating securities because they do not have a contractual obligation to share in the net loss of the Company.
The Company computes diluted net (loss)/income per ordinary share after giving consideration to all potentially dilutive ordinary equivalents, including stock options outstanding during the period, except where the effect of such non-participating securities would be antidilutive.
Diluted net (loss)/income per share is computed by dividing the net (loss)/income attributable to ordinary shareholders by the weighted-average number of ordinary shares and dilutive ordinary share equivalents outstanding for the period, determined using the treasury-stock and if-converted methods.
Contingent liabilities
A provision for contingent liabilities is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. The Company is a party to certain litigation and disputes arising in the normal course of business. As of December 31, 2023, the Company does not expect that such matters will have a material adverse effect on the Company’s business, financial position, results of operations, or cash flows.
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Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by FASB or other standard setting bodies that the Company adopts as of the specified effective date. The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different applications dates for public and nonpublic companies, the Company can adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and can do so until such time the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company.
Recently Issued Accounting Pronouncements
We have reviewed all recently issued standards and have determined that such standards will not have a material impact on our consolidated financial statements or do not otherwise apply to our current operations.
3. Foreign Currency Translation in General and Administrative Expenses
The aggregate, net foreign exchange gain or loss included in determining net (loss)/income recognized in general and administrative expenses for the year ended December 31, 2023, and 2022, was a loss of $ 7.6 million and a gain of $ 26.4 million, respectively.
4. Net (Loss)/Income Per Share
The following table sets forth the computation of basic and diluted net (loss)/income per share for the years ended December 31, 2023 and 2022 (in thousands, except number of shares and per share amounts):
Year Ended December 31,
Numerator: December 31, 2023 December 31, 2022
Net (loss)/income $ ( 73,447 ) $ 5,321
Net loss attributable to noncontrolling interest 100 21
Net (loss)/income attributable to Barinthus Biotherapeutics plc shareholders $ ( 73,347 ) $ 5,342
Denominator:
Weighted-average ordinary shares outstanding, basic 38,386,491 37,248,126
Effect of dilutive stock options — 921,181
Weighted-average ordinary shares outstanding, diluted 38,386,491 38,169,307
Net (loss)/income per share attributable to ordinary shareholders, basic $ ( 1.91 ) $ 0.14
Net (loss)/income per share attributable to ordinary shareholders, diluted $ ( 1.91 ) $ 0.14
Since the Company was in a loss position for 2023, basic net loss per share is the same as diluted net loss per share, as the inclusion of all potential ordinary share equivalents outstanding would have been anti-dilutive. For the year ended December 31, 2023, 6,207,664 potential ordinary shares issuable for stock options were excluded from the computation of diluted weighted-average shares outstanding because including them would have had an anti-dilutive effect. For the year ended December 31, 2022, 2,912,756 potential ordinary shares issuable for stock options, respectively, were excluded from the computation of diluted weighted-average shares outstanding because including them would have had an anti-dilutive effect.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
5. Property and Equipment, Net
Property and equipment, net consists of the following (in thousands):
December 31,
2023 December 31,
2022
Office furniture and equipment $ 1,108 $ 1,041
Laboratory equipment 5,728 4,312
Leasehold improvements 8,673 3,926
Property and equipment, at cost 15,509 9,279
Less: accumulated depreciation ( 3,688 ) ( 1,322 )
Property and equipment, net $ 11,821 $ 7,957
Depreciation expense for the year ended December 31, 2023 was $ 2.3 million (December 31, 2022: $ 1.1 million).
6. Intangible assets, net
The gross amount of amortizable intangible assets, consisting of acquired developed technology, was $ 31.6 million at both December 31, 2023 and 2022 and accumulated amortization was $ 6.5 million and $ 3.3 million as of December 31, 2023 and 2022, respectively. The amortization expense for the year ended December 31, 2023 was $ 3.2 million (December 31, 2022: $ 3.2 million). The estimated annual amortization expense is $ 3.2 million for the years 2024 through to 2031.
7. Prepaid and other current assets
Prepaid and other current assets consist of the following (in thousands):
December 31,
2023 December 31,
2022
Prepayments and accrued income $ 5,402 $ 5,887
Value Added Tax receivable 3,031 —
Lease incentives receivable — 1,770
Other 1,474 611
Total $ 9,907 $ 8,268
8. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following (in thousands):
December 31,
2023 December 31,
2022
Accrued manufacturing and clinical expenses $ 4,003 $ 2,997
Accrued bonus 2,412 1,925
Accrued payroll and employee benefits 789 928
Accrued professional fees 942 1,270
Accrued other 1,066 941
Total $ 9,212 $ 8,061
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9. Out-licenses and Grants
OUI license
In April 2020, the Company entered into an Amendment, Assignment and Revenue Sharing Agreement (“License Agreement Amendment”) with Oxford University Innovation, or OUI, which vested and assigned all intellectual property rights in relation to any ChAdOx1 or ChAdOx2 vector-based vaccine jointly owned by the Company and OUI in order to facilitate the license of vaccines based on the ChAdOx1 by OUI to AstraZeneca plc (“AstraZeneca”). Under this agreement, the Company is entitled to receive from OUI a share of all payments received by OUI from AstraZeneca in respect of the vaccine based on the ChAdOx1. On December 30, 2020, AstraZeneca announced that vaccine based on the ChAdOx1 which we refer to as Vaxzevria had been approved for emergency supply in the United Kingdom by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA).
The Company determined that the intellectual property vested and assigned under the License Agreement Amendment is a functional intellectual property (that is, it has significant standalone functionality in the form of its ability to treat a disease or condition) and there is no expectation under the License Agreement Amendment that the Company will undertake activities to change the functionality. Consequently, the Company concluded that the nature of the Company’s promise in transferring the intellectual property is to provide a right to use the Company’s functional intellectual property. Accordingly, the Company recognizes revenue in manner that depicts the Company’s progress toward satisfying its performance obligation of providing access to its intellectual property throughout the license period based on the terms of OUI’s agreement with AstraZeneca.
On March 28, 2022, pursuant to the OUI License Agreement Amendment, we were notified of the commencement of payments, arising from AstraZeneca’s commercial sales of Vaxzevria. Under the terms of an exclusive worldwide license agreement between OUI and AstraZeneca, OUI is entitled to milestone payments and royalties on commercial sales of Vaxzevria that began after the pandemic period. As part of the assignment from us to OUI, we are entitled to receive approximately 24 % of payments received by OUI from AstraZeneca. For the year ended December 31, 2023, the Company recognized approximately $ 0.8 million as revenue (year ended December 31, 2022: $ 43.7 million) and had an outstanding receivable of nil as of December 31, 2023 (2022: $ 5.5 million). There is no guarantee that further payments will be received pursuant to the agreement in the future and, if such payments are made, that we will be notified of such payments in a timely manner.
Scancell contract
On November 2, 2022, the Company entered into an agreement with Scancell to grant a research and development license, consisting of upfront and development milestone and royalty payments, for the development and commercialization of the SNAPvax functional intellectual property. The Company recognized non-refundable upfront revenue, amounting to nil for the year ended December 31, 2023 (December 31, 2022: $ 0.7 million). As of December 31, 2023, nil was recorded as a receivable (December 31, 2022: $ 0.3 million).
Coalition for Epidemic Preparedness Innovations (“CEPI”) Funding Agreement
On December 20, 2023, Barinthus Biotherapeutics (UK) Limited (the “Company”), the Chancellors, Masters and Scholars of the University of Oxford (“Oxford,” together with the Company, the “Partners”) and the Coalition for Epidemic Preparedness Innovations (“CEPI”) entered into a Funding Agreement (the “Funding Agreement”) pursuant to which CEPI will provide funding of up to $ 34.8 million to the Company to advance the development of VTP-500, the Company’s vaccine candidate against Middle East Respiratory Syndrome (“MERS,” and such development activities, the “Project”). In December 2023, VTP-500 received PRIME (PRIority MEdicines) designation by the European Medicines Agency.
Pursuant to the Funding Agreement, the Company has agreed to pay CEPI on a country-by-country basis increasing mid-single digit percentage royalties of net sales and net income with respect to future cash sales of VTP-500, less certain deductions, for a period starting on December 20, 2023 (“Effective Date”) and ending the later of: (i) the expiration of the last valid patent claim included in intellectual property developed under the Project covering VTP-500 in such country, (ii) the expiration of Regulatory Exclusivity (as defined in the Funding Agreement) for VTP-500 in such country, and (iii) the tenth ( 10 th) anniversary of the first commercial sale of VTP-500 (the “Royalty Term”). The Company shall also pay CEPI a mid-double digit percentage of net revenue earned on VTP-500 until CEPI has received payments from the Company under the Funding Agreement equaling the total amount of funding paid by CEPI to the Company and a low double-digit percentage of such net revenue thereafter. Sales for the benefit of end users in specified low and middle income countries
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(“LMICs”) and upper and middle income countries (“UMICs”) are excluded from the calculations of net sales and net revenue. Sales of product for the benefit of end users in LMICs and UMICs are subject to tiered discounted pricing requirements under the Funding Agreement. The Company is further required to pay a mid-double digit percentage of any proceeds earned on any priority review voucher related to VTP-500 during the Royalty Period.
For the year ended December 31, 2023, no proceeds have been received and no income has been recognized in relation to this contract as no activities eligible for the funding were undertaken during the period.
Contract assets and liabilities
The Company discloses accounts receivable separately in the consolidated balance sheets at the net amount expected to be collected. Contract assets primarily relate to the Company’s conditional right to consideration for work completed but not billed at the reporting date. As of December 31, 2023 and 2022 the Company did not have any contract assets.
Contract liabilities primarily relate to payments received from customers in advance of performance under the contract and are disclosed as deferred revenue separately in the consolidated balance sheets. The Company’s contract liabilities arise when payment is received upfront for various multi-period extended license and service arrangements.
Changes in the contract liabilities during the years ended December 31, 2023 and 2022, are as follows (in thousands):
December 31,
2023 December 31,
2022
Beginning balance $ — $ 182
Revenue recognized related to contract liability balance — ( 158 )
Foreign exchange translation — ( 24 )
Ending balance $ — $ —
10. Ordinary Shares
On May 4, 2021, the Company closed its initial public offering (“IPO”) of 6,500,000 ADS representing 6,500,000 ordinary shares having a nominal value of £ 0.000025 per share, at a public offering price of $ 17.00 per share, for aggregate net proceeds of $ 102.8 million after deducting underwriting commissions of $ 7.7 million and incurred offering costs of $ 2.2 million.
All ordinary shares rank pari passu as a single class. The following is a summary of the rights and privileges of the holders of ordinary shares as of December 31, 2023:
Liquidation preference: In the event of the liquidation, dissolution or winding up of the Company, the assets of the Company available for distribution to holders of the ordinary shares shall be distributed amongst all holders of the ordinary shares in proportion to the number of shares held irrespective of the amount paid or credited as paid on any share.
Dividends: Holders of the ordinary shares are entitled to dividends, as may be recommended from time to time by the Board and declared by the ordinary shareholders out of legally available funds.
Voting Rights: Each holder of ordinary shares is entitled to one vote for each share on all matters to be voted on by ordinary shareholders.
Preemption rights: Pursuant to section 561 of the Companies Act 2006, shareholders are granted preemptive rights when new shares are issued for cash. However, it is possible for our Articles, or shareholders at a general meeting representing at least 75 % of our ordinary shares present (in person or by proxy) and eligible to vote at that general meeting, to disapply these preemptive rights. Such a disapplication of preemption rights may be for a maximum period of up to five years from the date of the shareholder special resolution. In either case, this disapplication would need to be renewed by our shareholders upon its expiration (i.e., at least every five years ) to remain effective.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
On April 21, 2021, our shareholders approved the disapplication of preemptive rights for a period of five years from the date of approval by way of a special resolution of our shareholders. This included the disapplication of preemption rights in relation to the allotment of our ordinary shares in connection with the IPO. This disapplication will need to be renewed upon expiration (i.e., at least every five years ) to remain effective, but may be sought more frequently for additional five-year terms (or any shorter period).
On November 6, 2023, we held a general meeting where our shareholders approved resolutions granting our board of directors or any duly authorized committee of the board of directors the authority to allot shares in the Company or grant rights to subscribe for or to convert any security into shares in the Company free from preemption rights. Pursuant to such approval, our board of directors was authorized to allot shares up to an aggregate nominal amount of £ 1,928 free from statutory preemption rights.
As of December 31, 2023, the Company has reserved the following ordinary shares for future issuance:
Exercise of stock options 6,207,664
Shares available for future stock incentive plan awards 1,623,840
Total 7,831,504
11. Deferred shares
All deferred shares rank pari passu as a single class. The deferred shares do not have rights to dividends or to participate in profits on a return of assets on liquidation, the deferred shares confer on the holders thereof an entitlement to receive out of the assets of the Company available for distribution amongst the shareholders (subject to the rights of any new class of shares with preferred rights) the amount credited as paid up on the deferred shares held by them respectively after (but only after) payment shall have been made to the holders of the ordinary shares of the amounts paid up or credited as paid up on such shares and the sum of £ 1.0 million ($ 1.4 million) in respect of each ordinary share held by them respectively. The deferred shares shall confer on the holders thereof no further right to participate in the assets of the Company.
On March 29, 2023, all deferred B shares (nominal value of £ 0.01 each) and deferred C shares (nominal value of £ 0.00000736245954692556 each) previously in issue were transferred back to the Company and subsequently cancelled. These deferred shares had previously been issued to certain pre-IPO shareholders in connection with the implementation of certain stages of the Company’s pre-IPO share capital reorganization. The Company received shareholder pre-approval on April 21, 2021 (pursuant to the shareholder resolutions passed on that date) in order to effect the transfer back and cancellation of the deferred shares for nil consideration in accordance with sections 659 and 662 of the Companies Act 2006.
The Company’s deferred A shares with a nominal value of £ 1.00 each remain in issue for the purposes of satisfying the minimum share capital requirements for a public limited company as prescribed by the Companies Act 2006.
12. Fair Value
The Company’s financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable, certain accrued expenses, contingent consideration and short-term debt. The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, certain accrued expenses, contingent consideration and short-term debt approximated their respective fair value due to the short-term nature and maturity of these instruments.
As of December 31, 2023, the Company had a contingent consideration liability of $ 1.8 million related to the acquisition of Avidea Technologies, Inc. The fair value of the contingent consideration is a Level 3 valuation with the significant
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
unobservable inputs being the probability of success of achievement of the milestones and the expected date of the milestone achievement. Significant judgment is employed in determining the appropriateness of certain of these inputs.
The following table summarizes changes in the fair value of Contingent Consideration (in thousands):
Year ended December 31, 2023 Year ended December 31, 2022
Beginning balance $ 1,711 $ 2,371
Change in fair value recognized in net loss 55 ( 73 )
Settlement of contingency ( 163 ) ( 325 )
Foreign exchange translation recognized in other comprehensive loss 219 ( 262 )
Ending balance $ 1,823 $ 1,711
13. Goodwill
The following table summarizes changes in goodwill (in thousands):
Year ended
December 31,
2023 Year ended
December 31,
2022
Beginning balance $ 12,209 $ 12,630
Measurement period adjustments — ( 421 )
Ending balance $ 12,209 $ 12,209
14. Share-Based Compensation
On April 8, 2021, the Board of the Company adopted the Barinthus Biotherapeutics plc Share Award Plan 2021 (“the Plan”) and the Barinthus Biotherapeutics plc Non-Employee Sub-Plan which is a sub-plan of the Plan. Under the terms of the Plan, the Board is permitted to grant awards to employees as restricted share units, options, share appreciation rights and restricted shares. The aggregate number of shares initially available for issuance under the Plan and the Barinthus Biotherapeutics plc Non-Employee Sub-Plan cannot exceed 3,675,680 ordinary shares (the “Initial Limit”). Beginning calendar year 2023, the total number of ordinary shares available for issuance under the Plan shall be increased on January 1 of each year in an amount equal to the lesser of (i) 4 % of the Company’s issued and outstanding ordinary shares (which 4 % limit shall be measured as of January 1 of such year) and (ii) such number of ordinary shares as determined by the Compensation Committee of the Board in its discretion (the “Annual Increase”). In accordance with the terms of the Annual Increase, the total number of ordinary shares available for issuance under the Plan increased by 1,507,341 of January 1, 2023. The awards generally vest based on the grantee’s continued service with the Company during a specified period following grant as determined by the Board and generally expire ten years from the grant date. Option awards generally vest over three years , but vesting conditions can vary at the discretion of the Company’s Board. As of December 31, 2023 and 2022, 1,623,840 and 1,670,268 ordinary shares are available for future grants, respectively.
In 2018, the Company’s board of directors adopted the Enterprise Management Incentive Share Option Scheme (the “EMI Plan”) which provided for the grant of incentive stock options and nonqualified stock options to non-director employees of the Company. The Company also has a nonqualified stock option plan for officers and directors. The awards generally vest based on the grantee’s continued service with the Company during a specified period following grant as determined by the board of directors and generally expire ten years from the grant date. Option awards generally vest over three years , but vesting conditions can vary at the discretion of the Company’s board of directors. A total of 3,530,634 ordinary shares were reserved for issuance in accordance with the provisions of the EMI Plan and restricted stock unit (“RSUs”) plan. Upon adoption of the Plan, no further awards are to be made under the EMI Plan.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The fair value of each stock option issued to employees was estimated at the date of grant using Black-Scholes with the following weighted-average assumptions:
Year Ended,
2023 2022
Expected volatility 97.1 % 94.7 %
Expected term (years) 6 6
Risk-free interest rate 3.7 % 2.4 %
Expected dividend yield — % — %
Prior to the IPO, the Company applied a discount for lack of marketability calculated using the Finnerty model
Expected volatility: Previously there was insufficient trading history for the Company’s ordinary shares, therefore the expected price volatility for our ordinary shares was estimated using the average historical volatility of industry peers’ shares as of the grant date of our options over a period of history commensurate with the expected life of the options. When selecting industry peers used in measuring implied volatility, the Company considered the similarity of their products and business lines, as well as their stage of development, size and financial leverage. The Company applied this process consistently using the same or similar public companies until 2023. During 2023, the Company determined that there is sufficient historical information on volatility of its share price available and the expected volatility used in the fair value calculation of new option grants is calculated based on a blended volatility of both historical volatility of the Company's share price and the expected volatility of the average historical volatility of industry peers’ shares.
Expected term (years): Expected term represents the period that the Company’s option grants are expected to be outstanding. There is not sufficient historical share exercise data to calculate the expected term of the stock options. Therefore, the Company elected to utilize the simplified method to value option grants. Under this approach, the weighted-average expected life is presumed to be the average of the vesting term and the contractual term of the option.
Risk-free interest rate: The Company determined the risk-free interest rate by using a weighted-average equivalent to the expected term based on the daily U.S. Treasury yield curve rate in effect as of the date of grant.
Expected dividend yield: The Company does not anticipate paying any dividends in the foreseeable future.
A summary of stock option activity is presented below:
Number of
Stock Options Weighted-
average
Exercise
Price Per
Option Weighted-
average
Remaining
Contractual
Term (Years) Aggregate
Intrinsic Value
(in thousands)
Outstanding, January 1, 2023 4,884,720 $ 9.04 7.36 $ 2,619
Granted 2,288,236 2.51
Exercised ( 72,386 ) 0.00026
Forfeited/expired ( 892,906 ) 7.30
Outstanding, December 31, 2023 6,207,664 $ 6.91 7.95 $ 6,044
Exercisable, December 31, 2023 2,839,791 $ 8.91 7.33 $ 2,883
The weighted-average grant date per-share fair value of stock options granted during the year ended December 31, 2023 was $ 1.99 per share (December 31, 2022: $ 3.51 per share). The aggregate intrinsic value of stock options exercised during the year ended December 31, 2023 was $ 0.2 million (December 31, 2022: $ 0.8 million). As of December 31, 2023, there was $ 3.0 million (2022: $ 7.1 million) of unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted-average period of 1.60 years.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Share based compensation expense is classified in the consolidated statements of operations and comprehensive loss as follows (in thousands):
Year ended December 31, 2023 Year ended December 31, 2022
Research and development $ 2,011 $ 2,668
General and administrative 3,044 7,209
Total $ 5,055 $ 9,877
15. Income Taxes
(Loss) income before income taxes are as follows (in thousands):
Year ended
December 31,
2023 Year ended
December 31,
2022
United Kingdom $ ( 50,534 ) $ 15,511
United States ( 24,507 ) ( 14,648 )
Other foreign ( 1,481 ) ( 13 )
(Loss)/income before income taxes $ ( 76,522 ) $ 850
The components of income tax benefit are as follows (in thousands):
Year ended
December 31,
2023 Year ended
December 31,
2022
Current income tax benefit/(expense):
United States $ ( 28 ) $ 133
Other Foreign ( 45 ) —
Deferred income tax benefit:
United States 3,148 4,338
Total income tax benefit $ 3,075 $ 4,471
A reconciliation of the UK statutory income tax rate to the Company's effective tax rate as reflected in the consolidated financial statements is as follows:
Year ended
December 31,
2023 Year ended
December 31,
2022
Statutory tax rate 23.52 % 19.00 %
Increase (decreases) resulting from:
Permanent differences 1.03 ( 103.46 )
Provision to return adjustments ( 4.09 ) ( 105.66 )
Research and development credits ( 4.94 ) ( 307.09 )
Foreign rate differential 1.23 ( 149.82 )
Change in valuation allowance ( 11.84 ) 146.55
Share based compensation ( 0.84 ) ( 10.21 )
Effective tax rate 4.07 % ( 510.69 ) %
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income and for tax carryforwards. Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands):
December 31,
2023 December 31,
2022
Deferred tax assets:
Net operating loss carryforwards $ 23,589 $ 9,940
Research and development credit carryforwards 40 3,146
Deferred revenue — 54
Share based compensation 4,226 3,956
Lease liability 3,404 2,257
Accruals and intangibles 745 765
Capitalized Research and Development expenditure 4,228 2,522
Other 1 1
Gross deferred tax asset 36,233 22,641
Valuation allowance ( 25,057 ) ( 13,707 )
Net deferred tax assets 11,176 8,934
Deferred tax liabilities:
Depreciation ( 1,652 ) ( 1,704 )
Right-of-use lease asset ( 1,922 ) ( 1,993 )
Unrealized gain on investment ( 1,267 ) ( 1,204 )
Intangible assets ( 6,909 ) ( 7,779 )
Net deferred tax liabilities ( 11,750 ) ( 12,680 )
Total deferred tax, net $ ( 574 ) $ ( 3,746 )
Specified research and experimentation costs under Section 174 of the Internal Revenue Code are required to be capitalized and amortized ratably over five years for domestic expenditures and over 15 years for foreign expenditures. This provision of Section 174 became effective for tax years beginning after December 31, 2021. As a result of the capitalization of these costs in the current year, the Company has recorded a $ 4.2 million deferred tax asset (2022: $ 2.5 million).
As of December 31, 2023, the Company had a valuation allowance of $ 25.1 million (2022: $ 13.7 million) against its deferred tax assets, which consisted principally of net operating loss and research and development credit carryforwards. The Company considered the positive and negative evidence bearing upon its ability to realize the deferred tax assets. In addition to the Company’s history of cumulative losses, the Company cannot be certain that future taxable income will be sufficient to realize its deferred tax assets. Accordingly, a valuation allowance has been provided against its deferred tax assets. When the Company changes its determination as to the amount of its deferred tax assets that can be realized, the valuation allowance is adjusted with a corresponding impact to the provision for income taxes in the period in which such determination is made.
Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2023 and 2022 related primarily to the increase in net operating loss and credit carryforwards, and were as follows:
Year ended
December 31,
2023 Year ended
December 31,
2022
Valuations allowance at beginning of year $ 13,707 $ 13,500
Changes in valuation allowance arising from in-year additions 1,052 —
Increases recorded to income tax provision 9,605 1,500
Foreign exchange translation 693 ( 1,293 )
Valuation allowance at end of year $ 25,057 $ 13,707
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
As of December 31, 2023, the Company had net operating loss ("NOL") carryforwards totaling approximately $ 92.7 million which have an unlimited carryforward period, of which $ 74.2 million originate in the United Kingdom. As of December 31, 2023, the Company had $ 0.04 million of research and development tax credit carryforwards which also have an unlimited carryforward period.
As of December 31, 2022, the Company had NOL carryforwards totaling approximately $ 39.6 million which have an unlimited carryforward period, of which $ 35.1 million originate in the United Kingdom. As of December 31, 2022, the Company had $ 3.1 million of research and development tax credit carryforwards which also have an unlimited carryforward period.
As of December 31, 2023 and 2022, the Company does not have any material unrecognized tax benefit liabilities. The Company files corporation/income tax returns in the United Kingdom, Australia, and the United States. The associated tax filings remain subject to examination by applicable tax authorities for a certain length of time following the tax year to which those filings relate. In the United Kingdom, tax years from 2020 remain subject to examination by HMRC. In all other jurisdictions, the tax years since inception remain subject to examination by the applicable taxing authorities as of December 31, 2023 and 2022.
16. Commitments and Contingencies
In-License Agreements
The Company is party to a number of licensing agreements, these agreements serve to provide the Company with the right to develop and exploit the counterparties’ intellectual property for certain medical indications. As part of execution of these arrangements, the Company paid certain upfront fees, which have been expensed as incurred because the developing technology has not yet reached technical feasibility, the lack of alternative use, and the lack of proof of potential value. The agreements cover a variety of fields, including influenza, cancer, HPV, HBV and MERS. The Company’s obligations for future payments under these arrangements are dependent on its ability to develop promising drug candidates, the potential market for these candidates and potential competing products, and the payment mechanisms in place in countries where the Company retains the right to sell. Each agreement provides for specific milestone payments, typically triggered by achievement of certain testing phases in human candidates, and future royalties ranging from 1 to 5 % for direct sales of a covered product to 3 to 7 % of net payments received for allowable sublicenses of technology developed by the Company. The obligation to make these payments is contingent upon the Company’s ability to develop candidates for submission for phased testing and approvals, and for the development of markets for the products developed by the Company. The Company has not made any material payments under these license agreements during the years ended December 31, 2023, and 2022.
Leases
The Company leases certain laboratory and office space under operating leases, which are described below.
The Oxford Science Park, Oxford
The Company leased an office and laboratory space from a related party in Oxford, England under an operating lease with a contractual term expiring in 2028. The lease was terminated on July 31, 2022, and the Company relocated its corporate headquarters to The Harwell Science and Innovation Campus, Oxfordshire, in the third quarter of 2022.
The Harwell Science and Innovation Campus, Oxfordshire
On September 3, 2021, the Company entered into a lease agreement for the lease of approximately 31,000 square feet in Harwell, Oxfordshire which expires in September 2031. The property is the Company’s corporate headquarters. As the Company’s leases typically do not provide an implicit rate, the Company uses an estimate of its incremental borrowing rate based on the information available at the lease commencement date, being the rate incurred to borrow on a collateralized basis over a similar term at an amount equal to the lease payments in a similar economic environment. The Company has provided the lessor with a refundable security deposit of $ 0.7 million which is included in Other assets.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Germantown, Maryland
On June 14, 2022, the Company entered into a lease agreement for the lease of approximately 19,700 square feet in Germantown, Maryland. The site will house the Company’s state-of-the-art wet laboratory in the United States of America. The lease expires on February 28, 2034, with the Company having a single right to extend for an additional five years on the same terms and conditions other than for the base rent. The Company has a rent-free period up to February 29, 2024 and is entitled to up to $ 3.5 million for leasehold improvements to the premises desired by the Company. The Company has provided the lessor with a refundable security deposit of $ 0.2 million which is included in Other assets.
The Company recorded a right-of-use asset and a lease liability on the effective date of the lease term. The Company’s right-of-use assets and lease liabilities are as follows (in thousands):
December 31,
2023 December 31,
2022
Right-of-use asset $ 7,581 $ 7,753
Lease liability, current $ 1,785 $ 433
Lease liability, noncurrent $ 11,191 $ 8,340
Other information
Operating cash flows from operating leases $ 639 $ 1,081
Weighted average remaining lease term (years) 8.93 9.44
Weighted average discount rate 7.5 % 7.6 %
Lease Costs
Short-term lease costs $ 189 $ 529
Fixed Lease Costs $ 883 $ 1,216
Total lease cost
$ 1,072 $ 1,745
Maturities of the Company’s minimum lease liabilities as of December 31, 2023 were as follows (in thousands):
Maturity of lease liabilities:
2024 $ 1,785
2025 1,936
2026 1,960
2027 1,985
2028 2,010
Thereafter 7,999
Total minimum lease payments 17,675
Less: imputed interest ( 4,699 )
Total lease liability $ 12,976
Non-lease and other costs paid to the lessors are primarily related to services provided by the lessors in operating the premises that includes fees, operating costs, taxes, and insurance related to the leased premises.
Other contingencies
The Company is a party in various contractual disputes, litigation, and potential claims arising in the ordinary course of business. The Company does not believe that the resolution of these matters will have a material adverse effect on its financial position or results of operations.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
17. Employee Benefit Plans
In the United Kingdom, the Company has adopted a defined contribution plan (the U.K. Plan) which qualifies under the rules established by HM Revenue & Customs. Contributions to the U.K. Plan are charged to the consolidated statements of operations and comprehensive loss in the year to which they relate.
The Company has 401(k) defined contribution retirement plans in which all its employees located in the United States are eligible to participate. Eligible employees may elect to contribute up to the maximum limits, as set by the Internal Revenue Service, of their eligible compensation. Contributions to the plans are charged to the consolidated statements of operations and comprehensive loss in the year to which they relate.
During the year ended December 31, 2023, the Company provided a total of $ 0.7 million (December 31, 2022: $ 0.5 million) in contributions under both the U.K. Plan and the 401(k) plans.
18. Related Party Transactions
During the year ended December 31, 2023, the Company incurred expenses of $ 0.4 million (December 31, 2022: $ 0.4 million) from its shareholder, the University of Oxford, related to clinical study costs. As of December 31, 2023, the Company owed nil (2022: $ nil ).
During the year ended December 31, 2023, the Company incurred expenses of $ 0.6 million (December 31, 2022: $ 0.4 million) from Oxford University Innovation Limited which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford. As of December 31, 2023, the Company owed $ 2 thousand (December 31, 2022: nil ) to Oxford University Innovation Limited.
During the year ended December 31, 2023, the Company recognized license revenue of $ 0.8 million (December 31, 2022: $ 43.7 million) from Oxford University Innovation Limited which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford. As of December 31, 2023, the Company was owed nil (2022: $ 5.5 million) from Oxford University Innovation Limited.
19. Subsequent Events
In accordance with the terms of the Annual Increase of the Barinthus Biotherapeutics plc Share Award Plan 2021, the total number of ordinary shares available for issuance under the Plan increased by 4 % of the Company’s issued and outstanding ordinary shares as of January 1, 2024.
In January 2024, the Company granted a total of 1,592,423 share options to employees and directors with a weighted average exercise price of $ 3.70 .
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