7 unchanged sentences
Notes to Condensed Consolidated Financial Statements
−Removed: VACCITECH PLC
+Added: BARINTHUS BIOTHERAPEUTICS PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
+Added: September 30,
Current assets:
35 unchanged sentences
Accumulated other comprehensive loss – foreign currency translation adjustments
−Removed: Total shareholders’ equity attributable to Vaccitech plc shareholders’
+Added: Total shareholders’ equity attributable to Barinthus Biotherapeutics plc shareholders
Noncontrolling interest
3 unchanged sentences
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
−Removed: VACCITECH PLC
+Added: BARINTHUS BIOTHERAPEUTICS PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
1 unchanged sentence
Three months ended
−Removed: Six months ended
−Removed: June 30, 2023
−Removed: June 30, 2022
−Removed: June 30, 2023
−Removed: June 30, 2022
+Added: Nine months ended
+Added: September 30, 2023
+Added: September 30, 2022
+Added: September 30, 2023
+Added: September 30, 2022
License revenue 1
10 unchanged sentences
Research and development incentives
−Removed: Total other (expense) income
+Added: Other (expense)/ income, net
+Added: Total other income /(expense)
(Loss)/profit before income tax
1 unchanged sentence
Net loss attributable to noncontrolling interest
−Removed: Net (loss)/income attributable to Vaccitech plc shareholders
+Added: Net (loss)/income attributable to Barinthus Biotherapeutics plc shareholders
Weighted-average ordinary shares outstanding, basic
3 unchanged sentences
Net (loss)/income
−Removed: Other comprehensive gain/(loss) – foreign currency translation adjustments
+Added: Other comprehensive (loss)/gain – foreign currency translation adjustments
Comprehensive loss
Comprehensive loss attributable to noncontrolling interest
−Removed: Comprehensive loss attributable to Vaccitech plc shareholders
−Removed: 1 Includes license revenue from related parties for the three and six month periods ended June 30, 2023 of $ 0.3 million and $ 0.8 million, respectively and for the three and six month periods ended June 30, 2022 of $ 17.1 million and $ 32.1 million, respectively.
+Added: Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders
+Added: 1 Includes license revenue from related parties for the three and nine month periods ended September 30, 2023 of $ Nil million and $ 0.8 million, respectively and for the three and nine month periods ended September 30, 2022 of $ 6.2 million and $ 38.2 million, respectively.
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
−Removed: VACCITECH PLC
+Added: BARINTHUS BIOTHERAPEUTICS PLC
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
1 unchanged sentence
(IN THOUSANDS, EXCEPT NUMBER OF SHARES)
−Removed: Three and Six months ended June 30, 2023
+Added: Three and Nine months ended September 30, 2023
+Added: Total shareholders’
+Added: equity attributable
Ordinary Shares
3 unchanged sentences
Comprehensive
+Added: Biotherapeutics plc
Noncontrolling
2 unchanged sentences
Share based compensation
−Removed: Issue of ordinary shares, net of issuance costs
+Added: Issue of ordinary shares, net of issuance cost
Foreign currency translation adjustments
6 unchanged sentences
Balance, June 30, 2023
−Removed: Three and Six months ended June 30, 2022
+Added: Share based compensation
+Added: Issue of ordinary shares, net of issuance costs
+Added: Foreign currency translation adjustments
+Added: Balance, September 30, 2023
+Added: Three and Nine months ended September 30, 2022
+Added: Total shareholders’
+Added: Equity attributable
Ordinary Shares
3 unchanged sentences
Comprehensive
+Added: Biotherapeutics plc
Noncontrolling
6 unchanged sentences
Share based compensation
−Removed: Issue of ordinary shares, net of issuance cost
+Added: Issue of ordinary shares
Foreign currency translation adjustments
Balance, June 30, 2022
+Added: Share based compensation
+Added: Issue of ordinary shares
+Added: Foreign currency translation adjustments
+Added: Balance, September 30, 2022
1 Indicates amount less than thousand
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
−Removed: VACCITECH PLC
+Added: BARINTHUS BIOTHERAPEUTICS PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
−Removed: Six months ended
−Removed: June 30, 2023
−Removed: June 30, 2022
+Added: Nine months ended
+Added: September 30, 2023
+Added: September 30, 2022
CASH FLOWS FROM OPERATING ACTIVITIES:
4 unchanged sentences
Non-cash lease expenses
−Removed: Unrealized foreign exchange gain
+Added: Unrealized foreign exchange loss/( gain)
Non-cash interest expense
Change in contingent consideration
+Added: Profit on sale of property and equipment
Deferred tax benefit
9 unchanged sentences
Purchases of property and equipment
+Added: Proceeds from sale of property and equipment
Net cash used in investing activities
12 unchanged sentences
Capital expenditures included in accounts payable and accrued expenses
−Removed: ROU assets obtained in exchange for operating lease liabilities
+Added: Right-of-use assets obtained in exchange for operating lease liabilities
Asset retirement obligation
2 unchanged sentences
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
−Removed: VACCITECH PLC
+Added: BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Nature of Business and Basis of Presentation
−Removed: Vaccitech plc (“Vaccitech”) is a public limited company incorporated pursuant to the laws of England and Wales in March 2021.
−Removed: Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel T cell immunotherapeutics designed to harness the power of the immune system to treat chronic infectious diseases, cancer and autoimmunity.
−Removed: Vaccitech is headquartered in Harwell, Oxfordshire, United Kingdom.
−Removed: Vaccitech and its direct and indirect subsidiaries, Vaccitech (UK) Limited, Vaccitech Australia Pty Limited, Vaccitech Oncology Limited (“VOLT”), Vaccitech North America, Inc., Vaccitech Switzerland GmbH and Vaccitech Italia S.R.L, are collectively referred to as the “Company”.
−Removed: In connection with the initial public offering of American Depositary Shares (“ADSs”), in March 2021, Vaccitech completed a corporate reorganization wherein the shareholders of Vaccitech (UK) Limited exchanged each of their ordinary shares, series A shares and series B shares of Vaccitech (UK) Limited (formerly Vaccitech Limited) for the same quantity of ordinary shares, series A shares and series B shares in Vaccitech plc (resulting in the shareholders of the Company holding the same percentage and class of shares in Vaccitech plc (formerly Vaccitech Rx Limited) as they had in Vaccitech (UK) Limited.
−Removed: The group reorganization under common control constituted a change in reporting entity and has been given retrospective effect reflecting the net assets of Vaccitech (UK) Limited and its subsidiaries and Vaccitech plc at their historical carrying amounts.
+Added: Barinthus Biotherapeutics plc (formerly Vaccitech plc) is a public limited company incorporated pursuant to the laws of England and Wales in March 2021.
+Added: Barinthus Biotherapeutics plc and its direct and indirect subsidiaries, Barinthus Biotherapeutics (UK) Limited (formerly Vaccitech (UK) Limited), Vaccitech Australia Pty Limited, Vaccitech Oncology Limited (“VOLT”), Barinthus Biotherapeutics North America, Inc.
+Added: (formerly Vaccitech North America, Inc.), Barinthus Biotherapeutics Switzerland GmbH (formerly Vaccitech Switzerland GmbH) and Barinthus Biotherapeutics Italia S.R.L.
+Added: (formerly Vaccitech Italia S.R.L.), are collectively referred to as the “Company” or “Barinthus Bio”.
+Added: 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.
+Added: The Company is headquartered in Harwell, Oxfordshire, United Kingdom.
+Added: On November 6, 2023, the Company announced its renaming as Barinthus Bio to represent the evolution and expansion of its focus beyond vaccines.
+Added: 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).
+Added: 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.
−Removed: and Vaccitech North America, Inc., with Vaccitech North America, Inc.
+Added: and Barinthus Biotherapeutics North America, Inc., with Barinthus Biotherapeutics North America, Inc.
being the surviving entity.
10 unchanged sentences
Certain notes or other information that are normally required by GAAP have been omitted if they substantially duplicate the disclosures contained in the Company’s annual audited consolidated financial statements.
−Removed: Accordingly, the unaudited condensed consolidated financial statements should be read in connection with the Company’s audited financial statements and related notes as of and for the year ended December 31, 2022.
+Added: Accordingly, the unaudited condensed consolidated financial statements should be read in connection with the Company’s audited consolidated financial statements and related notes as of and for the year ended December 31, 2022.
The condensed consolidated balance sheet as of December 31, 2022, was derived from the audited financial statements but does not contain all of the footnote disclosures from the annual financial statements.
−Removed: As of June 30, 2023, the Company had cash and cash equivalents of $173.0 million and an accumulated deficit of $ 145.2 million, and the Company expects to incur losses for the foreseeable future.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: As of September 30, 2023, the Company had cash and cash equivalents of $ 160.3 million and an accumulated deficit of $ 159.3 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 for at least the next twelve months from the issuance of the financial statements.
2 unchanged sentences
The terms of any financing may adversely affect the holdings or rights of the Company’s stockholders.
−Removed: 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,
−Removed: VACCITECH PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: product portfolio expansion or future commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations.
+Added: 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.
1 unchanged sentence
Unaudited Condensed Financial Information
−Removed: The accompanying Condensed Consolidated Balance Sheets as of June 30, 2023, and December 31, 2022, the Condensed Consolidated Statements of Operations and Comprehensive Loss, Condensed Consolidated Statements of Changes in Shareholders’ Equity and the Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2023 and 2022 are unaudited.
+Added: The accompanying Condensed Consolidated Balance Sheets as of September 30, 2023, and December 31, 2022, the Condensed Consolidated Statements of Operations and Comprehensive Loss, Condensed Consolidated Statements of Changes in Shareholders’ Equity and the Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2023 and 2022 are unaudited.
These unaudited condensed consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities Exchange Commission (the “Annual Report”) on March 24, 2023.
−Removed: In our opinion, the unaudited condensed consolidated financial statements include all adjustments of a normal recurring nature necessary for the fair presentation of our financial position as of June 30, 2023, our results of operations for the three and six months ended June 30, 2023, and 2022, and our cash flows for the six months ended June 30, 2023, and 2022.
−Removed: The results of operations for the three and six months ended June 30, 2023, are not necessarily indicative of the results to be expected for the year ending December 31, 2023, or any other interim periods.
+Added: In our opinion, the unaudited condensed consolidated financial statements include all adjustments of a normal recurring nature necessary for the fair presentation of our financial position as of September 30, 2023, our results of operations for the three and nine months ended September 30, 2023, and 2022, and our cash flows for the nine months ended September 30, 2023, and 2022.
+Added: The results of operations for the three and nine months ended September 30, 2023, are not necessarily indicative of the results to be expected for the year ending December 31, 2023, or any other interim periods.
Summary of Significant Accounting Policies
1 unchanged sentence
Use of Estimates
−Removed: The preparation of unaudited condensed 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 condensed consolidated financial statements and the reported amounts of revenue, and expenses during the reporting period.
+Added: The preparation of unaudited condensed 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 condensed 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.
4 unchanged sentences
Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Recently issued accounting pronouncements
1 unchanged sentence
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 application 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 that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company.
−Removed: VACCITECH PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
We have reviewed all recently issued standards and have determined that such standards will not have a material impact on our condensed consolidated financial statements or do not otherwise apply to our current operations.
−Removed: Foreign currency translation in General and Administrative Expenses
−Removed: The aggregate, net foreign exchange gain or loss included in determining net (loss)/income recognized in general and administrative expenses for the three and six months ended June 30, 2023, was a loss of $ 4.2 million and a loss of $ 7.7 million, respectively.
−Removed: The aggregate net foreign exchange gain or loss included in determining net income recognized in general and administrative expenses for the three and six months ended June 30, 2022, was a gain of $ 15.2 million and a gain of $ 20.5 million, respectively.
+Added: Foreign Currency Transaction Gains/Losses in General and Administrative Expenses
+Added: The aggregate, net foreign exchange gain or loss included in determining net loss recognized in general and administrative expenses for the three and nine months ended September 30, 2023, was a gain of $ 6.6 million and a loss of $ 1.1 million, respectively.
+Added: The aggregate net foreign exchange gain or loss included in determining net income recognized in general and administrative expenses for the three and nine months ended September 30, 2022, was a gain of $ 18.7 million and a gain of $ 39.1 million, respectively.
Net (Loss)/Income Per Share
−Removed: The following table sets forth the computation of basic and diluted net (loss)/income per share for the three months and six months ended June 30, 2023, and 2022 (in thousands, except number of shares):
−Removed: Three months ended June 30,
−Removed: Six months ended June 30,
+Added: The following table sets forth the computation of basic and diluted net (loss)/income per share for the three months and nine months ended September 30, 2023, and 2022 (in thousands, except number of shares):
+Added: Three months ended September 30,
+Added: Nine months ended September 30,
Net (loss)/income
Net loss attributable to noncontrolling interest
−Removed: Net (loss)/income attributable to Vaccitech shareholders
+Added: Net (loss)/income attributable to Barinthus Bio shareholders
Weighted-average ordinary shares outstanding, basic
3 unchanged sentences
Net (loss)/income per share attributable to ordinary shareholders, diluted
−Removed: For the three and six month period ended June 30, 2023, 5,671,825 and 5,551,286 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.
−Removed: For the three and six month period ended June 30, 2022, 3,245,537 and 2,646,562 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.
+Added: Since the Company was in a loss position for all periods presented 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.
+Added: As of September 30, 2023, 6,391,680 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.
+Added: For the three and nine month period ended September 30, 2022, 3,201,290 and 2,697,808 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.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Property and Equipment, net
−Removed: During the six months ended June 30, 2023, the Company’s additions to property and equipment, net were $ 6.4 million which primarily related to an increase in leasehold improvements from the Company’s U.S.
−Removed: office in Germantown, Maryland (six months ended June 30, 2022:
+Added: During the nine months ended September 30, 2023, the Company’s additions to property and equipment, net were $ 5.9 million which primarily related to an increase in leasehold improvements from the Company’s U.S.
+Added: office in Germantown, Maryland (nine months ended September 30, 2022:
$ 6.8 million, related to leasehold improvements of the Company’s corporate headquarters).
−Removed: Depreciation expense for the three and six months ended June 30, 2023 was $ 0.5 million and $ 0.9 million, respectively.
−Removed: (June 30, 2022:
−Removed: three and six months was $ 0.2 million and $ 0.4 million, respectively).
−Removed: VACCITECH PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Depreciation expense for the three and nine months ended September 30, 2023 was $ 0.7 million and $ 1.6 million, respectively (September 30, 2022:
+Added: three and nine months was $ 0.4 million and $ 0.8 million, respectively).
Intangible Assets, net
−Removed: The gross amount of amortizable intangible assets, consisting of developed technology, was $ 31.6 million and $ 31.6 million as of June 30, 2023 and December 31 2022, respectively, and accumulated amortization was $ 4.9 million and $ 3.3 million as of June 30, 2023 and December 31, 2022, respectively.
−Removed: The amortization expense for the three and six months ended June 30, 2023 was $ 0.8 million and $ 1.6 million, respectively (three and six months ended June 30, 2022:
+Added: The gross amount of amortizable intangible assets, consisting of acquired developed technology, was $ 31.6 million and $ 31.6 million as of September 30, 2023 and December 31 2022, respectively, and accumulated amortization was $ 5.7 million and $ 3.3 million as of September 30, 2023 and December 31, 2022, respectively.
+Added: The amortization expense for the three and nine months ended September 30, 2023 was $ 0.8 million and $ 2.4 million, respectively (three and nine months ended September 30, 2022:
$ 0.8 million and $ 2.4 million, respectively).
1 unchanged sentence
Prepaid Expenses and Other Current Assets (in thousands):
+Added: September 30,
Prepayments and accrued income
−Removed: Employee retention and payroll tax credit
+Added: Value Added Tax receivable
Lease incentive receivable
Accrued Expenses and Other Current Liabilities (in thousands):
+Added: September 30,
Accrued manufacturing and clinical expenses
6 unchanged sentences
All ordinary shares rank pari passu as a single class.
−Removed: The following is a summary of the rights and privileges of the holders of ordinary shares as of June 30, 2023:
+Added: The following is a summary of the rights and privileges of the holders of ordinary shares as of September 30, 2023:
Liquidation preference:
2 unchanged sentences
Subject to the provisions of the Companies Act 2006, in so far as, in the board of directors’ opinions, the Company’s profits justify such payments, the board of directors may pay interim dividends on the Company’s ordinary shares.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Voting Rights:
4 unchanged sentences
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 by passing a special resolution.
−Removed: Such a disapplication of preemption rights may be for a maximum period of up to five years from the date
−Removed: VACCITECH PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: on which the shareholder resolution was passed.
+Added: Such a disapplication of preemption rights may be for a maximum period of up to five years from the date on which the shareholder resolution was passed.
In either case, this disapplication would need to be renewed by our shareholders upon its expiration ( i.e.
4 unchanged sentences
, at least every five years ) to remain effective, but may be sought more frequently for additional five-year terms (or any shorter period).
+Added: 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 pre-emption rights.
+Added: 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 pre-emption rights.
Deferred Shares
3 unchanged sentences
The deferred shares shall confer on the holders thereof no further right to participate in the assets of the Company.
−Removed: On March 29, 2023, the Company transferred back to the Company and subsequently cancelled all of its deferred B shares (nominal value of £ 0.01 each) and deferred C shares (nominal value of £ 0.00000736245954692556 each) which were previously in issue.
+Added: 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.
3 unchanged sentences
The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses approximated their respective fair value due to the short-term nature and maturity of these instruments.
−Removed: As of June 30, 2023, the Company had a contingent consideration liability of $ 2.1 million related to the acquisition of Avidea Technologies, Inc.
+Added: As of September 30, 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 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.
−Removed: VACCITECH PLC
+Added: BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1 unchanged sentence
Three months ended
−Removed: Six months ended
+Added: Nine months ended
+Added: September 30,
+Added: September 30,
Beginning balance
3 unchanged sentences
1 During the fourth quarter of 2022, the Company reclassified the change in fair value of Contingent Consideration from Other income and expense to General and Administrative operating expense.
−Removed: For the three and six month periods ending June 30, 2022, an expense of $ 0.6 million and $ 0.6 million, respectively, has been reclassified to conform the presentation for comparator periods.
+Added: For the three and nine month periods ending September 30, 2022, an expense of $ 0.3 million and $ 0.9 million, respectively, has been reclassified to conform the presentation for comparator periods.
The Company identified qualitative indicators of impairment due to a sustained decline in the price of the Company’s American Depositary Shares, whereby the market capitalization continues to be below the value of the net assets of the Company.
−Removed: Therefore, the Company performed an interim qualitative assessment as of June 30, 2023 to determine whether it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
−Removed: Based on this assessment, management determined it is not more likely than not that the fair value of the reporting unit is less than its carrying amount.
+Added: Therefore, the Company performed an interim qualitative assessment as of September 30, 2023 to determine whether it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
+Added: Based on this assessment, management determined it is not more likely than not that the fair value of the reporting unit is less than its carrying amount and hence no impairment loss has been recognized.
Share-Based Compensation
−Removed: During the six month period ended June 30, 2023, in accordance with the terms of the Annual Increase of the Vaccitech plc Share Award Plan 2021 (the “Plan”), 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, 2023.
−Removed: For the six months ended June 30, 2023, the Company granted 2,142,905 options to employees and directors with a weighted average grant date fair value of $ 2.00 and a weighted average exercise price of $ 2.51 per share.
−Removed: For the six months ended June 30, 2022, the Company granted 1,807,703 options to employees and directors with a weighted average grant date fair value of $ 3.72 and a weighted average exercise price of $ 10.59 per share.
−Removed: For the six months ended June 30, 2023, the Company canceled 217,860 options to employees and directors for forfeitures on unvested options when leaving the Company (June 30, 2022:
−Removed: cancelled 22,683 options).
+Added: During the nine month period ended September 30, 2023, in accordance with the terms of the Annual Increase of the Barinthus Biotherapeutics plc Award Plan 2021 (the “Plan”), 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, 2023.
+Added: For the nine months ended September 30, 2023, the Company granted 2,221,706 options to employees and directors with a weighted average grant date fair value of $ 1.99 and a weighted average exercise price of $ 2.50 per share (September 30, 2022:
+Added: granted 2,265,040 options,weighted average grant date fair value of $ 3.53 and a weighted average exercise price of $ 9.15 per share).
+Added: For the nine months ended September 30, 2023, 664,449 options (September 30, 2022:
+Added: 372,916 ) were forfeited.
The fair value of each stock option issued to employees was estimated at the date of grant using the Black-Scholes model with the following weighted-average assumptions:
−Removed: Six months ended
+Added: Nine months ended
+Added: September 30,
Expected volatility
2 unchanged sentences
Expected dividend yield
−Removed: As of June 30, 2023, 6,781,099 options with a weighted average exercise price of $ 9.51 were outstanding.
−Removed: As of June 30, 2023, there was $ 6.5 million unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 2.0 years.
−Removed: As of June 30, 2022, 4,944,406 options with a weighted average exercise price of $ 9.37 were outstanding.
−Removed: As of June 30, 2022, there was $ 11.5 million unrecognized compensation expense related to stock options, which is expected to be recognized over a weighted average period of 2.24 years.
−Removed: VACCITECH PLC
+Added: As of September 30, 2023, 6,391,680 options with a weighted average exercise price of $ 8.86 were outstanding.
+Added: As of September 30, 2023, there was $ 4.1 million unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 1.8 years.
+Added: As of September 30, 2022, 4,976,180 options with a weighted average exercise price of $ 8.90 were outstanding.
+Added: As of September 30, 2022, there was $ 8.7 million unrecognized compensation expense related to stock options, which is expected to be recognized over a weighted average period of 2.13 years.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Share based compensation expense is classified in the unaudited condensed consolidated statements of operations and comprehensive loss as follows (in thousands):
−Removed: Three months ended June 30,
−Removed: Six months ended June 30,
+Added: Three months ended September 30,
+Added: Nine months ended September 30,
Research and development
9 unchanged sentences
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.
−Removed: The Company has not made or accrued any material payments under these license agreements during the six month periods ended June 30, 2023 and 2022.
+Added: The Company has not made or accrued any material payments under these license agreements during the nine month periods ended September 30, 2023 and 2022.
The Company leases certain laboratory and office space under operating leases, which are described below.
10 unchanged sentences
The Company has provided the lessor with a refundable security deposit of $ 0.2 million which is included in Other assets.
−Removed: VACCITECH PLC
+Added: BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1 unchanged sentence
The Company’s right-of-use asset and lease liability are as follows (in thousands):
+Added: September 30,
Right-of-use asset
1 unchanged sentence
Operating lease liability, non-current
+Added: Nine months ended September 30,
+Added: Other information
+Added: Operating cash flows used for operating leases
Weighted average remaining lease term (years)
Weighted average discount rate
−Removed: Other information
+Added: Three months ended September 30,
+Added: Nine months ended September 30,
Short-term lease costs
−Removed: Operating cash flows operating leases
−Removed: Future annual minimum lease payments under operating leases as of June 30, 2023, were as follows (in thousands):
+Added: Fixed lease costs
+Added: Total lease cost
+Added: Future annual minimum lease payments under operating leases as of September 30, 2023, were as follows (in thousands):
Remainder of 2023
6 unchanged sentences
Regardless of the outcome, legal proceedings can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
−Removed: VACCITECH PLC
+Added: BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Related Party Transactions
−Removed: During the three and six months ended June 30, 2023, the Company incurred expenses of $ Nil and $ Nil respectively from its shareholder, Oxford Science Enterprises plc.
−Removed: During the three months and six months ended June 30, 2022, the Company paid $ 0.1 million and $ 0.05 million (after offsetting lease costs for laboratory and office space in Oxford of $ 0.07 million against a refund of $ 0.1 million) respectively to its shareholder, Oxford Science Enterprises plc, mostly related to the lease of a laboratory and office space in Oxford.
−Removed: As of June 30, 2023 the Company received Nil proceeds (December 31, 2022:
−Removed: the Company received proceeds of $ 0.4 million from the sale of property plant and equipment and earned a profit of $ 0.3 million).
−Removed: As of June 30, 2023 the Company owed Nil (December 31, 2022:
−Removed: $ 0.007 million) to Oxford Science Enterprises plc.
−Removed: During the three and six months ended June 30, 2023, the Company incurred expenses of $ Nil and $ Nil respectively (three and six months ended June 30, 2022:
−Removed: $ 0.2 million and $ 0.2 million respectively) to its shareholder, the University of Oxford, related to clinical study costs.
−Removed: As of June 30, 2023, the Company owed $ Nil (December 31, 2022:
+Added: During the three and nine months ended September 30, 2023, the Company incurred expenses of $ 0.1 million and $ 0.1 million respectively (three and nine months ended September 30, 2022:
+Added: $ Nil and $ 0.2 million respectively) to its shareholder, the University of Oxford, related to clinical study costs.
+Added: As of September 30, 2023, the Company owed $ 0.1 million (December 31, 2022:
$ Nil ) to the University of Oxford.
−Removed: During the three and six months ended June 30, 2023, the Company incurred expenses mainly related to the patent portfolio of $ 0.3 million and $ 0.4 million respectively (three and six months ended June 30, 2022:
−Removed: $ 0.07 and $ 0.3 million, respectively) from Oxford University Innovation Limited which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford.
−Removed: As of June 30, 2023, the Company owed $ 0.1 million (December 31, 2022:
+Added: During the three and nine months ended September 30, 2023, the Company incurred expenses of $ 0.2 million and $ 0.6 million respectively (three and nine months ended September 30, 2022:
+Added: $ 0.1 million and $ 0.4 million, respectively) from Oxford University Innovation Limited which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford.
+Added: As of September 30, 2023, the Company owed $ 0.2 million (December 31, 2022:
$ Nil ) to Oxford University Innovation Limited.
−Removed: During the three and six months ended June 30, 2023, the company recognized license revenue of $ 0.3 million and $ 0.8 million respectively (three and six months ended June 30, 2022:
+Added: During the three and nine months ended September 30, 2023, the Company recognized license revenue of $ Nil and $ 0.8 million respectively (three and nine months ended September 30, 2022:
$ 6.2 million and $ 38.2 million respectively), from Oxford University Innovation Limited.
−Removed: As of June 30, 2023, the Company was owed $ 0.3 million (December 31, 2022:
+Added: As of September 30, 2023, the Company was owed $ Nil (December 31, 2022:
$ 5.5 million) from Oxford University Innovation Limited.
−Removed: During the three months and six months ended June 30, 2023, the Company incurred expenses of $ Nil and $ Nil , respectively (three months and six months ended June 30, 2022:
−Removed: $ Nil and $ 0.001 million, respectively) to its shareholder, the Oxford University Hospitals, related to clinical study costs.
−Removed: As of June 2023, the Company owed $ Nil (December 31, 2022:
−Removed: $ Nil ) to Oxford University Hospitals.
Management ’ s Discussion and Analysis of Financial Condition and Results of Operations.
2 unchanged sentences
Factors that might cause future results to differ materially from those projected in the forward-looking statements include, but are not limited to, those set forth in our Annual Report on Form 10-K and in other filings with the SEC.
−Removed: We are a clinical-stage biopharmaceutical company engaged in the discovery and development of novel T cell immunotherapeutics designed to harness the power of the immune system to treat chronic infectious diseases, cancer and autoimmunity.
−Removed: We aim to treat and prevent infectious diseases and cancer by using our proprietary platforms to develop product candidates that stimulate powerful, targeted immune responses against pathogens, infected cells, and tumor cells.
−Removed: We design these product candidates to stimulate immune responses that are robust, highly specific, and are differentiated by the magnitude of the T cell populations induced, which exhibit critical functionality and durability.
−Removed: In the field of autoimmunity, we use our proprietary platform to develop product candidates that are designed to induce regulatory T cells to suppress specific immune responses and prevent/reverse autoimmunity.
−Removed: We are focused on applying our platform capabilities and the expertise of our team to address significant unmet medical needs in two settings - the therapeutic setting, for the treatment of chronic infectious diseases, cancer, and autoimmunity and the prophylactic setting, for the prevention of infectious diseases, based on our platform’s ability to respond rapidly to epidemic and pandemic threats.
−Removed: We have a broad pipeline of both clinical and preclinical stage therapeutic and prophylactic programs.
−Removed: Our current therapeutic programs include VTP-300 for the treatment of chronic hepatitis B infection, or CHB, VTP-200 for the treatment of HPV, VTP-850 for the treatment of prostate cancer, VTP-600 for the treatment of non-small cell lung cancer, or NSCLC, VTP-1000 for treatment of celiac disease, and VTP-1100 for treatment of HPV-associated cancers.
−Removed: The latter two programs are designed to utilize our SNAPvax platform.
−Removed: Our current prophylactic programs include VTP-400 for the prevention of herpes zoster, or shingles, and VTP-500 for the prevention of MERS.
−Removed: In addition, we co-invented a COVID-19 vaccine with the University of Oxford, the rights to which we assigned to Oxford University Innovation, or OUI, to facilitate the license of those rights by OUI to AstraZeneca UK Limited, or AstraZeneca.
−Removed: The vaccine, formerly referred to as AZD1222, is now authorized for use under the marketing name Vaxzevria in a number of countries.
−Removed: AstraZeneca has exclusive worldwide rights to develop and commercialize Vaxzevria.
+Added: We are 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.
+Added: Helping patients and their families is the guiding principle at the heart of Barinthus Bio.
+Added: The Company stands apart through its broad pipeline, built around four proprietary platform technologies;
+Added: two viral vector platforms, ChAdOx and MVA;
+Added: and two synthetic SNAP platforms, SNAP-TI (SNAP-Tolerance Immunotherapy) and SNAP-CI (SNAP-Cancer Immunotherapy), previously referred to collectively as SNAPvax TM .
+Added: These platforms are enabling the Company to develop antigen-specific immunotherapeutic candidates designed to optimize the disease-fighting capabilities of T cells and guide them towards a healthy balance.
+Added: Our immunotherapeutic candidates are designed to work by increasing disease-specific CD8 T cell activity in the case of chronic infectious diseases and cancers, or by dampening CD4 and CD8 T cells, and increasing regulatory T cells in autoimmunity.
+Added: Harnessing its range of proprietary viral vector and synthetic platform technologies, Barinthus Bio is advancing a pipeline of five product candidates across a diverse range of therapeutic areas, including:
+Added: VTP-300, a Phase 2 immunotherapeutic candidate designed as a potential component of a functional cure for chronic hepatitis B viral (HBV) infection;
+Added: VTP-200, a Phase 2 non-surgical product candidate for persistent high-risk human papillomavirus (HPV) with near term clinical read-outs;
+Added: VTP-1000, our first preclinical autoimmune candidate designed to utilize the SNAP-TI platform to treat patients with celiac disease;
+Added: VTP-850, a second-generation Phase 2 immunotherapeutic candidate designed to treat recurrent prostate cancer;
+Added: VTP-1100, our first preclinical cancer candidate, designed to utilize the SNAP-CI platform to treat patients with HPV-related cancer.
+Added: Alongside these proprietary programs, the Company has partnerships in place to advance three additional prophylactic and therapeutic product candidates in MERS (Middle East Respiratory Syndrome), Zoster and NSCLC (Non-Small Cell Lung Cancer).
+Added: The Company also co-invented a COVID-19 vaccine with the University of Oxford, which has been exclusively licensed worldwide to AstraZeneca.
+Added: The co-invention of the COVID-19 vaccine demonstrated the Company’s ability to navigate a changing environment with speed and efficiency and lead the way in responding to urgent medical needs, as well as providing a strong proof-of-concept for the ChAdOx platform.
+Added: Barinthus Bio’s proven scientific expertise, diverse portfolio and focus on product development uniquely positions the Company to navigate towards delivering treatments for patients with infectious diseases, autoimmunity and cancers that have a significant impact on their every day lives.
On May 4, 2021, we completed our initial public offering, or IPO, pursuant to which we issued and sold 6,500,000 American Depository Shares, or ADSs, at a public offering price of $17.00 per ADS, resulting in net proceeds of $102.8 million, after deducting underwriting discounts and commissions and offering expenses.
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As part of the assignment from us to OUI, we are entitled to receive approximately 24% of payments received by OUI from AstraZeneca.
−Removed: For the three and six months ended June 30, 2023, we recognized $0.3 million and $0.8 million respectively as revenue (three and six months ended June 30, 2022:
+Added: For the three and nine months ended September 30, 2023, we recognized $Nil and $0.8 million, respectively, as revenue (three and nine months ended September 30, 2022:
$6.2 million and $38.2 million).
−Removed: There is, however, no guarantee that such payments will continue in the future and, if they do, that we will be notified of such payments in a timely manner.
+Added: There is no guarantee that such payments will be made in the future and, if they do, that we will be notified of such payments in a timely manner.
On August 9, 2022, we filed a Registration Statement on Form S-3, as amended, or the Shelf, with the Securities and Exchange Commission in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million.
1 unchanged sentence
We also simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, providing for the offering, issuance and sale by us of up to an aggregate of $75.0 million of our ordinary shares represented by ADSs from time to time in “at-the-market” offerings under the Shelf.
−Removed: As of June 30, 2023, we have sold 1,063,683 ordinary shares represented by ADSs under the sales agreement, amounting to net proceeds of $2.7 million.
+Added: As of September 30, 2023, we have sold 1,064,587 ordinary shares represented by ADSs under the sales agreement, amounting to net proceeds of $2.7 million.
We incurred net losses each year since inception through to December 31, 2021.
For the year ended December 31, 2022, we generated net income of $5.3 million, primarily as a result of revenues arising from AstraZeneca sales of Vaxzevria and our agreement with OUI.
−Removed: For the six months ended June 30, 2023, we incurred a net loss of $42.0 million.
−Removed: As of June 30, 2023, we had an accumulated deficit of $145.2 million and we do not currently expect positive cash flows from operations in the foreseeable future.
+Added: For the nine months ended September 30, 2023, we incurred a net loss of $56.2 million.
+Added: As of September 30, 2023, we had an accumulated deficit of $159.3 million and we do not currently expect positive cash flows from operations in the foreseeable future.
We expect to incur net operating losses for at least the next several years as we advance our product candidates through clinical development, seek regulatory approval, prepare for approval, and in some cases proceed to commercialization of our product candidates, as well as continue our research and development efforts and invest to establish a commercial manufacturing facility, as and when appropriate.
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In some circumstances, such as the emergence of a significantly more effective therapy from a competitor, it may be appropriate to discontinue a product candidate program.
−Removed: We expect that our cash balance as of June 30, 2023 will enable us to fund our operating expenses and capital requirements into the second quarter of 2025.
+Added: We expect that our cash balance as of September 30, 2023 will enable us to fund our operating expenses and capital requirements into the second quarter of 2025.
Recent Developments
−Removed: Developing a Non-Invasive Treatment for Persistent High-Risk HPV
−Removed: On April 20, 2023, the company presented topline data from the VTP-200 HPV001 phase 1b/2 clinical trial at the 35th Annual International Papillomavirus Conference (IPVC).
−Removed: The poster showed data for 42 women at Day 35, 7 days after the last dose of VTP-200, split by active treatment versus placebo.
−Removed: VTP-200 was generally well-tolerated and was administered with no product-related grade 3 unsolicited adverse events and no product-related SAEs.
−Removed: While the placebo group showed no antigen-specific T cell responses as measured by IFNg ELISpot, 26 of 29 women receiving varying doses of VTP-200 showed a response.
−Removed: The pooled active groups showed meaningful responses, with the average being greater than 1,000 spot-forming units per million peripheral blood mononuclear cells.
−Removed: Responses were strongest to the E1, E2 and E6 antigens.
−Removed: In addition, intracellular cytokine staining data from the active groups showed both CD4 and CD8 responses.
−Removed: The final dataset, including data on clearance of infection and cervical lesions at 12 months post-treatment, is expected in the second quarter of 2024.
−Removed: An Immunotherapeutic Targeting Prostate Cancer
−Removed: On June 12, 2023, Vaccitech announced the dosing of the first patient in the PCA001 clinical trial (NCT05617040).
−Removed: PCA001 is a multi-center, Phase 1/2 clinical trial designed to determine the recommended Phase 2 regimen and evaluate the safety, efficacy, as measured by prostate-specific antigen (PSA) response, and T cell response of VTP-850 monotherapy in men with rising PSA after definitive local therapy for their disease (i.e., biochemical recurrence).
−Removed: VTP-850 is a next-generation prostate cancer immunotherapeutic candidate which utilizes Vaccitech’s sequential dosing approach of two proprietary nonreplicating viral vectors, ChAdOx and MVA.
−Removed: PCA001 builds on the previous promising data from the University of Oxford VANCE01 (NCT02390063) and ADVANCE (NCT03815942) trials, Phase 1 and Phase 1/2 clinical trials respectively, of VTP-800, the first-generation product candidate which encoded 5T4, an antigen expressed by most prostate cancers.
−Removed: VTP-850 is a multi-antigen immunotherapeutic candidate containing four prostate-associated antigens:
−Removed: PSA, PAP, STEAP1 and 5T4.
−Removed: The first phase of the trial is enrolling participants in the US, with plans to open further sites in Italy and Spain.
−Removed: An Immunotherapeutic Targeting Chronic HBV Infection
−Removed: On June 21, 2023, Eleanor Barnes, Professor of Hepatology and Experimental Medicine at Oxford University, presented positive final data from the HBV002 clinical trial at the European Association for the Study of the Liver Congress 2023 – The International Liver Congress TM .
−Removed: HBV002 (NCT04778904) is a Phase 1b/2a clinical trial of VTP-300 in adults with chronic Hepatitis B (“CHB”).
−Removed: Meaningful, durable reductions of Hepatitis B Surface Antigen (HBsAg) were seen in all participants with a >0.5 log10 reduction in HBsAg who received VTP-300 alone (Group 2) or in combination with a single administration of low-dose PD-1 inhibitor, nivolumab (Group 3).
−Removed: Two of five patients with baseline HBsAg below 100 IU/mL in Group 3, developed a non-detectable HBsAg level, which continued eight months after last dose.
−Removed: Reductions in HBsAg were most prominent in those with lower baseline HBsAg.
−Removed: Importantly, all participants who received VTP-300 and experienced a >0.5 log10 reduction in HBsAg had durable responses with reductions in HBsAg persisting through to the last measurement eight months post-final dose.
−Removed: VTP-300, encoding Hepatitis B virus (“HBV”) genotype C antigens, led to a decline in HBsAg in the majority of participants infected with genotypes B and C viruses.
−Removed: In addition, VTP-300-induced T cells showed cross-reactivity to the core antigen from genotypes A to E in ELISpot assays using PBMC from VTP-300-treated healthy subjects and genotype-specific peptides A-E.
−Removed: A robust T cell response was generated against all VTP-300 antigens and was highest in the VTP-300 alone group.
−Removed: In that group, there was a relation between ELISpot responses and HBsAg decline.
−Removed: HBV002 was an open-label Phase 1b/2 study to evaluate the safety, tolerability and immunology readout (T cell responses) of VTP-300, with or without low-dose nivolumab, in people with CHB who are virally suppressed with oral anti-viral therapies.
−Removed: In the HBV002 study, 55 participants were randomized into four groups to receive combinations of VTP-300 and low-dose nivolumab, with follow-up for eight months post-final dose.
−Removed: VTP-300 as monotherapy and in combination with low-dose nivolumab was administered with no treatment-related serious adverse events.
−Removed: As reported previously, two out of 55 participants experienced transaminase flares.
−Removed: Both incidents occurred in participants with HBsAg declines, but not in any of the participants who cleared HBsAg (<0.05 IU/mL).
−Removed: Meaningful, durable reductions of HBsAg were seen in Group 2 (receiving VTP-300 monotherapy, N=18).
−Removed: Three participants had 0.7, 0.7, and 1.4 log10 declines two months post-final dose, with durable responses continuing eight months post-final dose.
−Removed: These participants all had baseline HBsAg <50 IU/mL.
−Removed: A robust T cell response was generated and was highest in this group and there was a relation demonstrated between ELISpot response and HBsAg decline.
−Removed: Those in Group 3 received VTP-300 followed by a single low dose of nivolumab together with Modified Vaccinia Ankara (“MVA”)-HBV (N=18).
−Removed: Two months post-final dose, the mean reduction in HBsAg was 0.76 log10 (p<0.001).
−Removed: This effect persisted with a mean decline of 0.98 log10 at eight months (p<0.001) after the last dose and was most prominent with starting values HBsAg <1,000 IU/mL.
−Removed: Two participants developed non-detectable HBsAg levels, which continued eight months after last dose.
−Removed: Pre-genomic RNA levels fell significantly in the majority of participants in this group only, consistent with the decline in HBsAg levels.
−Removed: Groups 1 and 4
−Removed: No meaningful reductions in HBsAg were observed in Group 1, in which participants received two doses of MVA-HBV without ChAdOx1-HBV, or in Group 4, in which participants received low-dose nivolumab with both doses of VTP-300.
−Removed: These groups were discontinued following interim analysis, as previously announced in June 2022.
−Removed: A Phase 2b clinical trial (HBV003;
−Removed: NCT05343481) to evaluate timing of the low dose nivolumab, additional doses of the MVA component of VTP-300 and a nucleos(t)ide analogues discontinuation protocol, has been initiated in multiple countries across the Asia-Pacific region, with over 60% of the 120 participants enrolled to date (40 per group).
−Removed: We are in the process of submitting a protocol amendment to modify the enrollment criteria in the ongoing HBV003 study to only enroll patients with starting HBV surface antigen levels of less than 200 IU/mL, which is the patient population where we have seen the majority of responses to date.
−Removed: In addition, we intend to exclude patients with pre-existing thyroid antibodies and patients with abnormal Thyroid stimulating hormone levels as we have observed adverse drug reactions in such patients to nivolumab, which have been described in the nivolumab labelling.
−Removed: Interim data from HBV003 is expected in the fourth quarter of 2023.
−Removed: In addition, a Phase 2a clinical trial (ACTRN12622000317796), in collaboration with Arbutus Biopharma Corporation, is evaluating the safety, antiviral activity and T cell responses of VTP-300 administered after Arbutus’ AB-729 in 40 virologically-suppressed people with chronic HBV infection, with interim data expected in the fourth quarter of 2023.
−Removed: Management Team
−Removed: On July 20, 2023, Dr.
−Removed: Margaret Marshall notified the Company of her intention to retire from her position as Chief Medical Officer, effective immediately.
−Removed: In connection with her retirement, Dr.
−Removed: Marshall and the Company will enter into a consulting agreement.
+Added: These are estimated timelines only and our pipeline may be subject to change.
+Added: General Meeting to Approve the Authorization to Allot Shares in the Company and Grant Subscription and Conversion Rights Free From Pre-Emption Rights
+Added: 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 pre-emption rights.
+Added: 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 pre-emption rights.
+Added: Name Change to Barinthus Biotherapeutics plc
+Added: On November 6, 2023, the Company announced its renaming as Barinthus Biotherapeutics plc to represent the evolution and expansion of its focus beyond vaccines.
+Added: The Company’s new name takes inspiration from “Barinthus”, the mythological navigator who guided King Arthur of Britain by ship to the island of Avalon to be healed when he was wounded.
+Added: The story of the legendary king being guided to a place of healing is mirrored in our proprietary platforms and technology that are designed to guide the immune system to treat infectious diseases, autoimmunity and cancer.
+Added: The Company announced that as part of the renaming, its ticker on Nasdaq was changed to BRNS, and the name change and ticker change became effective on Nasdaq on November 7, 2023.
+Added: Impact of Israel and Gaza Conflict
+Added: In respect of the international situation in Israel and Gaza, we have no operations or suppliers based in Israel or Gaza, and as a result, as of the date of this Quarterly Report on Form 10-Q, we believe the impact on the Company’s business, operations and financial condition will be minimal.
Impact of the Ukraine Crisis
−Removed: In respect of the international situation in Ukraine, we have assessed the impact on the Company as minimal.
−Removed: We have no operations or suppliers based in Ukraine, Belarus, or Russia, and there is consequently no additional risk or negative impact on the unaudited condensed consolidated financial statements.
+Added: In respect of the international situation in Ukraine, we have no operations or suppliers based in Ukraine, Belarus or Russia, and as a result, as of the date of this Quarterly Report on Form 10-Q, we believe the impact on the Company’s business, operations and financial condition will be minimal.
Impact of Global Economic Conditions and Inflationary Pressures
10 unchanged sentences
In March 2022, we were notified by OUI of the commencement of revenue relating to the commercial sales of Vaxzevria.
−Removed: Our revenue for the three and six months ending June 30, 2023 was $0.3 million and $0.8 million, respectively (three and six months ending June 30, 2022:
−Removed: $17.1 million and $32.1 million, respectively), representing the amounts we have been notified of as due by
−Removed: OUI to date and an estimate of future receipts, constrained to the extent that it is probable that a significant reversal of revenue would not occur.
+Added: Our revenue for the three and nine months ending September 30, 2023 was $Nil and $0.8 million, respectively (three and nine months ending September 30, 2022:
+Added: $6.2 million and $38.2 million, respectively), representing the amounts we have been notified of as due by OUI to date and an estimate of future receipts, constrained to the extent that it is probable that a significant reversal of revenue would not occur.
We determined that we have no further performance obligations under the terms of the OUI License Agreement Amendment, which comprised the transfer of intellectual property rights only.
3 unchanged sentences
Research and Development Expenses
−Removed: Since our inception, we have focused significant resources on our research and development activities, including establishing and building on our adenovirus platform, further enhancing our in-licensed ChAdOx1, ChAdOx2 and MVA vectors, developing a new next-generation adenoviral vector, acquiring new technology platforms including SNAPvax, conducting preclinical studies, developing various manufacturing processes, and advancing clinical development of our programs including Phase 2 clinical trials for VTP-100, which we subsequently discontinued development of, as well as initiating the clinical trials for VTP-200, VTP-300, VTP-600 and VTP-850 and readying VTP-500, VTP-1000 and VTP-1100 for clinical trials.
+Added: Since our inception, we have focused significant resources on our research and development activities, including establishing and building on our adenovirus platform, further enhancing our in-licensed ChAdOx1, ChAdOx2 and MVA vectors, developing a new next-generation adenoviral vector, acquiring new technology platforms including SNAP (SNAP-TI and SNAP-CI), conducting preclinical studies, developing various manufacturing processes, and advancing clinical development of our programs including Phase 2 clinical trials for VTP-100, which we subsequently discontinued development of, as well as initiating the clinical trials for VTP-200, VTP-300, VTP-600 and VTP-850 and readying VTP-500, VTP-1000 and VTP-1100 for clinical trials.
Research and development activities account for a large portion of our operating expenses, and we expect research and development expenses to increase in the future.
2 unchanged sentences
● salaries, benefits, and other related costs, including share-based compensation, for personnel engaged in research and development functions;
−Removed: ● expenses incurred in connection with the development of our programs including preclinical studies and clinical trials of our product candidates, under agreements with third parties, such as consultants, contractors, academic institutions and CROs;
−Removed: ● the cost of manufacturing drug products for use in preclinical development and clinical trials, including agreements with third parties, such as CMOs, consultants and contractors;
+Added: ● expenses incurred in connection with the development of our programs including preclinical studies and clinical trials of our product candidates, under agreements with third parties, such as consultants, contractors, academic institutions and contract research organizations (“CRO”);
+Added: ● the cost of manufacturing drug products for use in preclinical development and clinical trials, including agreements with third parties, such as contract manufacturing organizations, consultants and contractors;
● laboratory costs;
1 unchanged sentence
General and Administrative Expenses
−Removed: Our general and administrative expenses consist primarily of personnel costs, including share-based compensation, in our executive, finance, business development and other administrative functions.
−Removed: Other general and administrative expenses include consulting fees and professional service fees for auditing, tax and legal services, rent expenses related to our offices, depreciation, foreign exchange gains and losses on our cash balances and other central non-research costs.
−Removed: For the three and six month period ended June 30, 2023, we recognized a change in fair value in relation to the updated assumptions in the assessment of the contingent consideration fair value recognized from the acquisition of Avidea on December 10, 2021.
+Added: Our general and administrative expenses consist primarily of personnel-related expenses, including share-based compensation, in our executive, finance, business development and other administrative functions.
+Added: Other general and administrative expenses include consulting fees and professional service fees for auditing, tax and legal services, rent expenses related to our offices, depreciation, foreign exchange gains and losses on our cash balances, other central non-research costs and changes in the fair value of contingent consideration.
Significant judgment is used to determine the probability of success of achievement of the technology and clinical milestones and the date of the expected milestone.
3 unchanged sentences
Interest Income
−Removed: Interest income results primarily from the interest earned on our short-term cash deposits and cash balances held by Vaccitech (UK) Limited.
+Added: Interest income results primarily from the interest earned on our short-term cash deposits and cash balances held by Barinthus Biotherapeutics (UK) Limited.
Research and Development Incentives
2 unchanged sentences
The Company benefits from the United Kingdom research and development tax credit regime, being the Small and Medium-sized Enterprises R&D tax relief program, or SME Program, and, to the extent that our projects are grant funded or relate to work subcontracted to us by third parties, the Research and Development Expenditure Credit program, or RDEC Program.
−Removed: Under the SME program, the Company is 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.
+Added: 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.
1 unchanged sentence
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.
+Added: 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.
The Company may not be able to continue to claim research and development tax credits under the SME program in the future because it may no longer qualify as a small or medium-sized company.
4 unchanged sentences
If such an exception does not apply, this could restrict the amount of payable credit that we claim.
−Removed: 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.
Unsurrendered UK losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions.
2 unchanged sentences
This discussion and analysis of financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or U.S.
−Removed: The preparation of unaudited condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period.
−Removed: On an ongoing basis, management evaluates its estimates, including those related to revenue, expenses, accruals and prepayments for external manufacturing of clinical trial material as well as clinical study conduct, fair value of contingent consideration, impairment of goodwill and intangible assets, and the fair value of ordinary shares and share-based compensation.
+Added: The preparation of unaudited condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue, income and expenses during the reporting period.
+Added: On an ongoing basis, management evaluates its estimates, including those related to expenses, accruals and prepayments for external manufacturing of clinical trial material as well as clinical study conduct, fair value of contingent consideration, impairment of goodwill and intangible assets, and the fair value of ordinary shares and share-based compensation.
Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances.
1 unchanged sentence
We believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our unaudited condensed consolidated financial statements and understanding and evaluating our reported financial results.
−Removed: Recognition of Revenue from Contracts with Customers
−Removed: In 2020, we entered into the OUI License Agreement Amendment with OUI to facilitate the license of our rights to the COVID-19 vaccine we co-invented with OUI to AstraZeneca, which is now known as Vaxzevria.
−Removed: Our performance obligations under the terms of this agreement are limited to the transfer of intellectual property rights (licenses and other rights).
−Removed: Payments by AstraZeneca to OUI under this agreement include an up-front payment, payments based upon the achievement of defined milestones, royalties on product sales, and may include payments of commercial and other milestones, if certain future conditions are met.
−Removed: We are entitled to receive approximately 24% of receipts, including royalties and milestones, received by OUI from that license agreement with AstraZeneca as set out in the OUI License Agreement Amendment.
−Removed: We evaluate our collaboration and licensing arrangements pursuant to Accounting Standards Codification 606, or ASC 606.
−Removed: We use judgment to determine whether milestones or other variable consideration, except for sales-based royalties, should be included in the transaction price.
−Removed: For sales-based and clinical development milestones and royalties, when the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of when the related sales or milestone achievement occurs or when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
−Removed: 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 Costs
Research and development costs are expensed as incurred.
−Removed: Research and development expenses consist of costs incurred in performing research and development activities, including salaries and bonuses, share-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation, manufacturing expenses and external costs of vendors engaged to conduct preclinical development activities and clinical trials as well as the cost of licensing technology.
+Added: Research and development expenses consist of costs incurred in performing research and development activities, including salaries and bonuses, share-based compensation, employee benefits, facilities costs,
+Added: laboratory supplies, depreciation, manufacturing expenses and external costs of vendors engaged to conduct preclinical development activities and clinical trials as well as the cost of licensing technology.
Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses.
1 unchanged sentence
Research and development costs are accrued when the related services or goods are delivered ahead of being billed.
−Removed: All patent-related costs incurred in connection with filing and prosecuting patent applications are classified as research and development costs and expensed as incurred due to the uncertainty about any future recovery of the expenditure.
Upfront payments, milestone payments and annual payments made for the licensing of technology are generally expensed as research and development in the period in which they are incurred.
1 unchanged sentence
Share-based Compensation
−Removed: We grant options and restricted shares to employees and directors and account for share-based compensation using a fair value method.
+Added: We grant options to employees and directors and account for share-based compensation using a fair value method.
All of these arrangements are settled in equity at a predetermined price and generally vest over a period of three years.
1 unchanged sentence
To the extent such incentives are in the form of share options, up until the first quarter of 2021, the options may have been granted pursuant bilateral EMI option awards or unapproved option awards.
−Removed: On April 8, 2021, we adopted the Vaccitech plc Share Award Plan 2021 and the Vaccitech plc Non-Employee Sub-Plan which is a sub-plan of the Vaccitech plc Share Award Plan 2021.
−Removed: Under the terms of the Vaccitech plc Share Award Plan 2021, the Board is permitted to grant awards to employees as restricted share units, options, share appreciation rights or restricted shares.
−Removed: Upon adoption of the Vaccitech plc Share Award Plan 2021, no further awards are granted pursuant to the bilateral EMI option awards or unapproved option awards.
+Added: On April 8, 2021, we adopted the Barinthus Bio Share Award Plan 2021 (formerly, the Vaccitech plc Share Award Plan 2021) and the Barinthus Bio Non-Employee Sub-Plan (formerly, the Vaccitech plc Non-Employee Sub-Plan) which is a sub-plan of the Barinthus Bio Share Award Plan 2021.
+Added: Under the terms of the Barinthus Bio Share Award Plan 2021, the Board is permitted to grant awards to employees as restricted share units, options, share appreciation rights or restricted shares.
+Added: Upon adoption of the Barinthus Bio Share Award Plan 2021, no further awards are granted pursuant to the bilateral EMI option awards or unapproved option awards.
Share based compensation awards are measured at the grant date fair value.
3 unchanged sentences
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.
−Removed: We have elected to recognize the effect of forfeitures on share-based compensation
−Removed: when they occur.
+Added: We have 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.
2 unchanged sentences
The volatility assumption utilizes both the Company’s historical volatility and those of a portfolio of listed peer companies, weighted towards the Company as we build the historical records following IPO.
−Removed: The assumptions used in the Black-Scholes model to determine fair value for the share option grants during the six months ended June 30, 2023 and 2022 were:
−Removed: June 30, 2023
−Removed: June 30, 2022
+Added: The assumptions used in the Black-Scholes model to determine fair value for the share option grants during the nine months ended September 30, 2023 and 2022 were:
+Added: September 30, 2023
+Added: September 30, 2022
Expected volatility
2 unchanged sentences
Expected dividend yield
−Removed: For the six months ended June 30, 2023, 2,142,905 share options were granted and 1,807,703 share options were granted for the six months ended June 30, 2022.
+Added: For the nine months ended September 30, 2023, 2,221,706 share options were granted and 2,265,040 share options were granted for the nine months ended September 30, 2022.
Business Combinations
We acquired Avidea on December 10, 2021 and have accounted for the acquisition using the acquisition method of accounting.
−Removed: This required us to assess and make judgments as to whether the acquisition met the criteria of a business combination or an asset acquisition.
+Added: This required us to assess and make judgments as to whether the acquisition met the criteria of a business combination or an asset
In determining that the acquisition of Avidea met the criteria of a business combination we first used the “screen test” to assess whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets.
6 unchanged sentences
We acquired Avidea for an up-front amount of $32.8 million (after working capital adjustments), of which $11.8 million was payable in cash and $21.0 million in 2,151,831 of American Depositary Shares of the Company.
−Removed: In addition, Avidea’s stockholders may be entitled to receive an aggregate of up to $40.0 million in additional payments, payable in a mixture of cash and ADSs, upon the achievement of certain milestones.
+Added: In addition, Avidea’s stockholders may be entitled to receive an aggregate of up to $40.0 million in additional payments, payable in a combination of cash and ADSs, upon the achievement of certain milestones.
This contingent consideration is included within the purchase price and is recognized at its fair value on the acquisition date, and subsequently remeasured to fair value at each reporting date until the contingency is resolved.
−Removed: Changes in fair value are recognized in earnings in the condensed consolidated statements of operations and comprehensive loss.
+Added: Changes in fair value are recognized in general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss.
The fair value of contingent consideration is based on the probability of pursuit of the activity associated with the milestone, the probability of success of the achievement of the milestone, the expected date of milestone achievement and applying the relevant discount rate.
8 unchanged sentences
Because there are inherent uncertainties involved in these factors, significant differences between these estimates and actual results could result in future impairment charges and could materially impact our future financial results.
−Removed: The goodwill of $12.2 million as of June 30, 2023 wholly relates to the acquisition of Avidea on December 10, 2021.
−Removed: During the year ended December 31, 2022, the Company identified qualitative indicators of impairment due to a sustained decline in the price of the Company’s American Depositary Shares, whereby the market capitalization fell below the value of the net assets of the Company, which continued through to the second quarter of 2023.
−Removed: Therefore, the Company performed an interim assessment as of June 30, 2023 to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount.
−Removed: Based off this assessment, the Company has not recognized any impairment losses related to goodwill or intangible assets for the three or six months ending June 30, 2023.
+Added: The goodwill of $12.2 million as of September 30, 2023 wholly relates to the acquisition of Avidea on December 10, 2021.
+Added: During the year ended December 31, 2022, the Company identified qualitative indicators of impairment due to a sustained decline in the price of the Company’s American Depositary Shares, whereby the market capitalization fell below the value of the net assets of the Company, which continued through to the third quarter of 2023.
+Added: Therefore, the Company performed an interim assessment as of September 30, 2023 to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount.
+Added: Based off this assessment, the Company has not recognized any impairment losses related to goodwill or intangible assets for the three or nine months ending September 30, 2023.
Results of Operations
−Removed: Comparison of the Three Months Ended June 30, 2023 and 2022
+Added: Comparison of the Three Months Ended September 30, 2023 and 2022
The following table sets forth the significant components of our results of operations (in thousands):
+Added: ended September
+Added: ended September
Revenue from Licenses, Grants & Services
8 unchanged sentences
Research and development incentives
+Added: Other expense
Total other income
1 unchanged sentence
Net (loss)/income
−Removed: For the three months ended June 30, 2023, and 2022, our revenue consisted of $0.3 million and $17.1 million respectively, from the OUI License Agreement Amendment with respect to payments from OUI in connection with commercial sales of Vaxzevria, which reduced due to lower sales in the period.
+Added: For the three months ended September 30, 2023, and 2022, our revenue consisted of $Nil and $6.2 million respectively, from the OUI License Agreement Amendment with respect to payments from OUI in connection with commercial sales of Vaxzevria.
+Added: There is no guarantee that such payments will be made in the future and, if they do, that we will be notified of such payments in a timely manner.
Research and Development Expenses
−Removed: The following table summarizes our research and development expenses for the three months ended June 30, 2023 and 2022 (in thousands):
+Added: The following table summarizes our research and development expenses for the three months ended September 30, 2023 and 2022 (in thousands):
+Added: ended September
+Added: ended September
Direct research and development expenses by program:
4 unchanged sentences
Total direct research and development expenses
−Removed: Internal research and development expenses:
+Added: Indirect research and development expenses:
Personnel-related (including share-based compensation)
1 unchanged sentence
Other internal costs
−Removed: Total internal research and development expenses
+Added: Total indirect research and development expenses
Total research and development expenses
−Removed: Our research and development expenses for the three months ended June 30, 2023 and 2022 were $13.5 million and $9.7 million, respectively.
−Removed: Direct expenses for the three months ended June 30, 2023 and 2022 were $9.6 million and $7.2 million, respectively, and consisted of outside services, consultants, laboratory materials, clinical trials, manufacturing of clinical trial materials, as well as costs for external preclinical services and sample testing.
−Removed: Of the $2.4 million increase, $3.0 million pertains to the commencement of VTP-1000 Celiac disease and VTP-1100 HPV cancer programs in IND-enabling studies.
−Removed: VTP-200 increased by $1.0 million due to topline HPV001 Phase 1b/2 clinical trial data that was presented at the 35 th Annual International Papillomavirus Conference in April 2023.
−Removed: These increases were offset by a $0.8 million decrease in other and earlier stage programs, $0.6 million decrease in VTP-300 and $0.2 million decrease in VTP-850, reflective of the current status in the pipeline.
−Removed: Internal research and development expenses for the three months ended June 30, 2023 and 2022 were $3.9 million and $2.5 million, respectively.
−Removed: Of the $1.4 million increase, $1.2 million pertains to personnel-related expenses as a result of the relative increase in headcount across locations in the United Kingdom and United States.
+Added: Our research and development expenses for the three months ended September 30, 2023 and 2022 were $15.1 million and $9.7 million, respectively.
+Added: Direct expenses for the three months ended September 30, 2023 and 2022 were $11.6 million and $6.7 million, respectively, and consisted of outside services, consultants, laboratory materials, clinical trials, manufacturing of clinical trial materials, as well as costs for external preclinical services and sample testing.
+Added: Of the $4.9 million increase, $2.5 million pertains to the commencement of VTP-1000 Celiac disease and VTP-1100 HPV cancer programs in IND-enabling studies, costs related to these studies appear in other and earlier stage programs in the prior period.
+Added: In addition, VTP-300 HBV increased by $2.5 million mainly due to an increase in clinical trial cost and manufacturing development costs following the dosing of the first patient in HBV003, a Phase 2b clinical trial of VTP-300, in October 2022.
+Added: These increases were offset by a $0.6 million decrease related to other and early stage programs due to the commencement of VTP-1000 Celiac disease and VTP-1100 HPV cancer programs.
+Added: Indirect research and development expenses for the three months ended September 30, 2023 and 2022 were $3.5 million and $3.1 million, respectively.
+Added: Of the $0.5 million increase, $0.3 million related to the increase in our research and development overhead costs.
General and Administrative Expenses
−Removed: General and administrative expenses for the three months ended June 30, 2023 were $13.1 million mainly attributable to personnel expense of $2.7 million, including share-based payment charge of $1.0 million, foreign exchange loss of $4.2 million, insurance cost of $1.2 million, legal and professional fees of $1.5 million and other expenses of $3.5 million.
−Removed: General and administrative expenses for the three months ended June 30, 2022 were a gain of $5.9 million.
−Removed: General and administrative expenses for the three months ended June 30, 2022, excluding foreign exchange were $ 9.3 million, which were mainly attributable to personnel expenses of $4.3 million, including the share-based payment charge of $2.1 million, insurance costs of $1.6 million and legal and professional fees of $1.0 million, $0.6 million contingent consideration adjustment, netted by unrealized foreign exchange gain on cash balances of $15.2 million.
+Added: General and administrative expenses for the three months ended September 30, 2023 were $1.0 million, which were primarily attributable to personnel-related expenses of $3.4 million, including share-based compensation expenses of $0.8 million, facility related costs of $1.6 million, legal and professional fees of $1.0 million and insurance costs of $0.5 million, partially offset by foreign exchange gains of $6.6 million.
+Added: General and administrative expenses for the three months ended September 30, 2022 were a gain of $10.8 million, due to a foreign exchange gain of $18.7 million primarily on revaluation of cash balances due to the fluctuations between the United States dollar and pound sterling exchange rates.
+Added: This gain was partially offset by personnel-related expenses of $2.8 million, including share-based compensation expenses of $0.6 million, insurance costs of $1.5 million, legal and professional fees of $2.3 million and a contingent consideration adjustment of $0.3 million.
Interest Income
−Removed: For the three months ended June 30, 2023 and 2022, interest income was $0.5 million and $0.7 million, respectively, resulting from the interest earned on our short-term cash deposits held by Vaccitech (UK) Limited.
+Added: For the three months ended September 30, 2023 and 2022, interest income was $0.2 million and $1.0 million, respectively, resulting from the interest earned on our short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.
Research and Development Incentives
−Removed: For the three months ended June 30, 2023 and 2022, research and development incentives were $0.6 million and $0.8 million, respectively.
+Added: For the three months ended September 30, 2023, research and development incentives were $1.2 million.
Such research and development incentives relate to corporation tax relief on research and development projects incentive programs in the United Kingdom.
−Removed: For the three months ended June 30, 2023 and 2022, the tax benefit was $1.1 million and $0.9 million respectively, which primarily relates to movements in deferred tax.
−Removed: Comparison of the Six Months Ended June 30, 2023 and 2022
+Added: For the three months ended September 30, 2022, research and development incentives were an expense of $0.7 million as a result of a reduction in forecast losses available to surrender for the receipt of research and development incentive in Barinthus Biotherapeutics (UK) Limited.
+Added: For the three months ended September 30, 2023 and 2022, the tax benefit was $0.6 million and $0.7 million respectively, which primarily relates to movements in deferred tax.
+Added: Comparison of the Nine Months Ended September 30, 2023 and 2022
The following table sets forth the significant components of our results of operations (in thousands):
+Added: ended September
+Added: ended September
Revenue from Licenses, Grants & Services
11 unchanged sentences
Net (loss)/income
−Removed: For the six months ended June 30, 2023, and 2022, our revenue consisted of $0.8 million and $32.1 million respectively, primarily from the OUI License Agreement Amendment with respect to payments from OUI in connection with commercial sales of Vaxzevria, which reduced due to lower sales in the period.
+Added: For the nine months ended September 30, 2023, and 2022, our revenue consisted of $0.8 million and $38.2 million respectively, primarily from the OUI License Agreement Amendment with respect to payments from OUI in connection with commercial sales of Vaxzevria.
+Added: There is no guarantee that such payments will be made in the future and, if they do, that we will be notified of such payments in a timely manner.
Research and Development Expenses
−Removed: The following table summarizes our research and development expenses for the six months ended June 30, 2023 and 2022 (in thousands):
+Added: The following table summarizes our research and development expenses for the nine months ended September 30, 2023 and 2022 (in thousands):
+Added: ended September
+Added: ended September
Direct research and development expenses by program:
4 unchanged sentences
Total direct research and development expenses
−Removed: Internal research and development expenses:
+Added: Indirect research and development expenses:
Personnel-related (including share-based compensation)
1 unchanged sentence
Other internal costs
−Removed: Total internal research and development expenses
+Added: Total indirect research and development expenses
Total research and development expenses
−Removed: Our research and development expenses for the six months ended June 30, 2023 and 2022 were $23.4 million and $20.4 million, respectively.
−Removed: Direct expenses for the six months ended June 30, 2023 and 2022 were $15.4 million and $14.8 million, respectively, and consisted of outside services, consultants, laboratory materials, clinical trials, manufacturing of clinical trial materials, as well as costs for external preclinical services and sample testing.
−Removed: Of the $0.6 million increase, $4.6 million pertains to the commencement of VTP-1000 Celiac disease and VTP-1100 HPV cancer programs.
−Removed: $1.2 million of the increase pertains to VTP-200 due to topline HPV001 phase 1b/2 clinical trial data presented at the 35 th Annual International Papillomavirus Conference in April 2023.
−Removed: These increases were offset by $2.7 million decrease related to VTP-300, as a result of completing the HBV002 Phase 2 clinical trial with final data that was presented at the European Association for the Study of the Liver (EASL) Congress in June 2023, and continuing enrollment in the HBV003 Phase 2 clinical and the AB-729-202 Phase 2a clinical collaboration with Arbutus, and a $1.3 million decrease that pertains to VTP-850 which progressed to first patient dosed in PCA001, a phase 1/2 clinical, in June 2023.
−Removed: A further $1.3 million of the decrease relates to reductions in other and earlier stage programs due to a decrease in earlier stage activity following the launch of the preclinical programs for VTP-1000 Celiac disease and VTP-1100 HPV cancer.
−Removed: Internal research and development expenses for the six months ended June 30, 2023 and 2022 were $7.9 million and $5.6 million, respectively.
−Removed: Of the $2.3 million increase, $2.1 million pertains to personnel-related expenses as a result of the relative increase in headcount across locations in the United Kingdom and United States.
+Added: Our research and development expenses for the nine months ended September 30, 2023 and 2022 were $38.5 million and $30.2 million, respectively.
+Added: Direct expenses for the nine months ended September 30, 2023 and 2022 were $27.1 million and $21.5 million, respectively, and consisted of outside services, consultants, laboratory materials, clinical trials, manufacturing of clinical trial materials, as well as costs for external preclinical services and sample testing.
+Added: Of the $5.6 million increase, $7.1 million pertains to the commencement of VTP-1000 Celiac disease and VTP-1100 HPV cancer programs, costs related to these studies appear in other and earlier stage programs in the prior period.
+Added: In addition, $1.2 million of the increase pertains to VTP-200 due to the HPV001 phase 1b/2 clinical trial enrollment completing in January 2023, with safety and immunogenicity data presented at the 35 th Annual International Papillomavirus Conference in April 2023.
+Added: These increases were partially offset by $1.9 million decrease related to other and early stage programs due to the commencement of VTP-1000 Celiac disease and VTP-1100 HPV cancer programs which were included in other and earlier stage programs during the nine months to September 30, 2022.
+Added: Indirect research and development expenses for the nine months ended September 30, 2023 and 2022 were $11.4 million and $8.7 million, respectively.
+Added: Of the $2.8 million increase, $2.2 million pertains to personnel-related expenses as a result of an increase in headcount across locations in the United Kingdom and United States, partially offset by a decrease in share-base compensation expenses due to forfeitures.
General and Administrative Expenses
−Removed: General and administrative expenses for the six months ended June 30, 2023 were $25.3 million mainly attributable to personnel expense of $6.2 million, including share-based payment charge of $2.1 million, foreign exchange loss of $7.7 million, insurance cost of $2.7 million, legal and professional fees of $2.7 million and other expenses of $6.0 million.
−Removed: General and administrative expenses for the six months ended June 30, 2022 were a gain of $2.2 million due to the foreign exchange gain of $20.4 million primarily on revaluation of cash balances due to the fluctuations between the United States dollar and pound sterling exchange rates.
−Removed: General and administrative expenses for the six months ended June 30, 2022, excluding foreign exchange gain, were $18.2 million, which were mainly attributable to personnel expenses of $9.3 million, including the share-based payment charge of $5.2 million, insurance costs of $3.3 million, legal and professional fees of $2.3 million and $0.6 million in changes in fair value assumptions in respect of contingent consideration.
+Added: General and administrative expenses for the nine months ended September 30, 2023 were $26.2 million mainly attributable to personnel-related expenses of $9.6 million, including share-based compensation expenses of $2.9 million, legal and professional fees of $3.7 million, insurance costs of $3.2 million, facility related costs of $2.9 million, amortization of intangible assets of $2.4 million and foreign exchange loss of $1.1 million.
+Added: General and administrative expenses for the nine months ended September 30, 2022 were a gain of $13.0 million, due to a foreign exchange gain of $39.1 million primarily on revaluation of cash balances due to the fluctuations between the United States dollar and pound sterling exchange rates.
+Added: This gain was partially offset by personnel-related expenses of $12.1 million, including share-based compensation expenses of $5.8 million, insurance costs of $4.8 million, legal and professional fees of $4.6 million and a contingent consideration adjustment of $0.9 million.
Interest Income
−Removed: For the six months ended June 30, 2023 and 2022, interest income was $2.1 million and $0.8 million resulting from the interest earned on our short-term cash deposits held by Vaccitech (UK) Limited.
+Added: For the nine months ended September 30, 2023 and 2022, interest income was $2.3 million and $1.8 million resulting from the interest earned on our short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.
Research and Development Incentives
−Removed: For the six months ended June 30, 2023 and 2022 research and development incentives were $1.7 million and $1.9 million, respectively.
+Added: For the nine months ended September 30, 2023, research and development incentives were $2.9 million.
Such research and development incentives relate to corporation tax relief on research and development projects incentive programs in the United Kingdom.
−Removed: For the six months ended June 30, 2023 and 2022, the tax benefit was $1.7 million and $1.8 million respectively, which primarily relates to movements in deferred tax.
+Added: For the nine months ended September 30, 2022, research and development incentives were $1.2 million as a result of a reduction in forecast losses available to surrender for the receipt of research and development incentive in Barinthus Biotherapeutics (UK) Limited.
+Added: For the nine months ended September 30, 2023 and 2022, the tax benefit was $2.3 million and $2.5 million respectively, which primarily relates to movements in deferred tax.
Liquidity and Capital Resources
1 unchanged sentence
Since our inception, we have funded our operations primarily through private and public placements of our ordinary and preferred shares as well as from grants and research incentives, various agreements with public funding agencies, the issuance of convertible loan notes, and most recently from upfront, royalty and milestone payments from OUI in connection with the OUI License Agreement Amendment.
−Removed: Through June 30, 2023, we had received gross proceeds of approximately $329.0 million from the issuance of our ordinary and preferred shares and convertible loan notes.
−Removed: As of June 30, 2023, we had cash and cash equivalents of $173.0 million.
+Added: Through September 30, 2023, we received gross proceeds of approximately $327.6 million from the issuance of our ordinary and preferred shares and convertible loan notes.
+Added: As of September 30, 2023, we had cash and cash equivalents of $160.3 million.
Key financing and corporate milestones include the following:
4 unchanged sentences
● In May 2021, we raised gross proceeds of $110.5 million from the initial public offering of our ordinary shares on NASDAQ;
−Removed: ● Between April 2022 and June 2023, we received $44.2 million of cash from OUI for the commercial sales of Vaxzevria;
−Removed: ● Between December 2022 and June 2023, we raised net proceeds of $2.7 million from the issuance of shares represented by ADSs through “at-the-market” offerings under the sales agreement with Jefferies LLC.
+Added: ● Between April 2022 and September 2023, we received $44.5 million of cash from OUI for the commercial sales of Vaxzevria;
+Added: ● Between December 2022 and September 2023, we raised net proceeds of $2.7 million from the issuance of shares represented by ADSs through “at-the-market” offerings under the sales agreement with Jefferies LLC.
On August 9, 2022, we filed a Registration Statement on Form S-3, as amended, or the Shelf, with the Securities and Exchange Commission in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million.
1 unchanged sentence
We also simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, providing for the offering, issuance and sale by us of up to an aggregate of $75.0 million of our ordinary shares represented by ADSs from time to time in “at-the-market” offerings under the Shelf.
−Removed: As of June 30, 2023, we have sold 1,063,683 ordinary shares represented by ADSs under the sales agreement amounting to net proceeds of $2.7 million.
+Added: As of September 30, 2023, we have sold 1,064,587 ordinary shares represented by ADSs under the sales agreement amounting to net proceeds of $2.7 million.
We do not currently expect positive cash flows from operations in the foreseeable future, if at all.
−Removed: In most periods, we have incurred operating losses as a result of ongoing efforts to develop our heterologous ChAdOx1-MVA prime-boost immunotherapy platform and our product candidates, including conducting ongoing research and development, preclinical studies, clinical trials, providing general
−Removed: and administrative support for these operations and developing our intellectual property portfolio.
+Added: In most periods, we have incurred operating losses as a result of ongoing efforts to develop our heterologous ChAdOx1-MVA prime-boost immunotherapy platform and our product candidates, including conducting ongoing research and development, preclinical studies, clinical trials, providing general and administrative support for these operations and developing our intellectual property portfolio.
We expect to continue to incur net negative cash flows from operations for at least the next few years as we progress clinical development, seek regulatory approval, prepare for and, if approved, proceed to manufacture and commercialization of our most advanced product candidates.
1 unchanged sentence
The following table sets forth a summary of the primary sources and uses of cash (in thousands) for each period presented:
+Added: ended September
+Added: ended September
Net cash used in operating activities
4 unchanged sentences
Cash Used in Operating Activities
−Removed: During the six months ended June 30, 2023, net cash used in operating activities was $20.1 million, primarily resulting from our net loss of $42.0 million adjusted by share based compensation of $4.2 million, depreciation and amortization of $2.5 million, non-cash lease expenses of $0.6 million, foreign exchange gain of $7.1 million, contingent consideration adjustment of $0.3 million, deferred tax benefit of $1.7 million and changes in our operating assets and liabilities, net of $8.9 million primarily related to the receipt of lease incentives for Vaccitech NA and OUI receivable.
−Removed: During the six months ended June 30, 2022, net cash used in operating activities was $15.0 million, primarily resulting from our net income of $18.3 million, adjusted by foreign exchange gain on translation of $18.7 million, share based compensation of $6.7 million, depreciation and amortization of $2.0 million, non-cash lease expenses of $0.5 million, and changes in our operating assets and liabilities, net of $22.6 million primarily resulting from the OUI receivable for the second quarter revenue, and an increase in prepaid expenses due to the payment of annual insurance premiums.
+Added: During the nine months ended September 30, 2023, net cash used in operating activities was $31.3 million, primarily resulting from our net loss of $56.2 million adjusted by share based compensation of $4.3 million, depreciation and amortization of $4.0 million, non-cash lease expenses of $0.8 million, foreign exchange loss of $0.9 million, deferred tax benefit of $2.3 million, and changes in our operating assets and liabilities, net of $17.1 million primarily related to a $5.8 million decrease in accounts receivable, a $5.2 million decrease in prepaid expenses and other current assets, and a $5.2 million increase in accrued expenses.
+Added: During the nine months ended September 30, 2022, net cash used in operating activities was $3.1 million, primarily driven by our net income of $26.5 million resulting from $38.2 million in revenue, adjusted by foreign exchange gain of $36.6 million, share based compensation of $7.8 million, depreciation and amortization of $3.1 million, non-cash lease expenses of $0.8 million, and changes in our operating assets and liabilities, net of $2.9 million primarily resulting from the OUI receivable for the third quarter revenue, and an increase in prepaid expenses due to the payment of annual insurance premiums that occurred in the second quarter, netted by an increase in accrued expenses.
Net Cash Used in Investing Activities
−Removed: During the six months ended June 30, 2023, cash used in investing activities was $5.5 million primarily resulting from capital expenditures related to leasehold improvements on our new office in Germantown, Maryland, United States.
−Removed: During the six months ended June 30, 2022, cash used in investing activities was $3.1 million primarily resulting from capital expenditures related to our new headquarters in Harwell, United Kingdom.
+Added: During the nine months ended September 30, 2023, cash used in investing activities was $5.6 million primarily resulting from capital expenditures related to leasehold improvements on our new office in Germantown, Maryland, United States.
+Added: During the nine months ended September 30, 2022, cash used in investing activities was $5.2 million primarily resulting from capital expenditures related to our new headquarters in Harwell, United Kingdom.
Net Cash Provided by/(Used in) Financing Activities
−Removed: During the six months ended June 30, 2023, cash provided by financing activities was $1.7 million mainly as a result of net proceeds from the issuance of ordinary shares through the “at-the-market” sales agreement.
−Removed: During the six months ended June 30, 2022, cash used in financing activities was $0.2 million resulting from the repayment of debt incurred previously by the acquired company Avidea (acquired on December 10, 2021, and subsequently became Vaccitech North America, Inc.).
+Added: During the nine months ended September 30, 2023, cash provided by financing activities was $1.8 million mainly as a result of net proceeds from the issuance of ordinary shares through the “at-the-market” sales agreement.
+Added: During the nine months ended September 30, 2022, cash used in financing activities was $0.2 million resulting from the repayment of debt incurred previously by the acquired company Avidea (acquired on December 10, 2021), and subsequently became Barinthus Biotherapeutics North America, Inc.
Effect of exchange rates on cash and cash equivalents
−Removed: During the six months ended June 30, 2023 and 2022, the effect of foreign exchange on cash and cash equivalents was gain of $2.6 million and loss of $3.5 million respectively, primarily as a result of fluctuations between the United States dollar and pound sterling exchange rates.
+Added: During the nine months ended September 30, 2023 and 2022, the effect of foreign exchange on cash and cash equivalents was gain of $1.0 million and loss of $5.5 million respectively, primarily as a result of fluctuations between the United States dollar and pound sterling exchange rates.
Future Funding Requirements
1 unchanged sentence
As a result, we have incurred losses in each year since our inception in 2016, through to December 31, 2021.
−Removed: We were profitable in 2022, however we have negative operating cash flows as of June 30, 2023.
−Removed: As of June 30, 2023, we had an accumulated deficit of $145.2 million.
+Added: We were profitable in 2022, however we have negative operating cash flows for the period ended September 30, 2023.
+Added: As of September 30, 2023, we had an accumulated deficit of $159.3 million.
We expect to continue to incur significant losses and negative cash flows from operations for the foreseeable future.
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We may require substantial additional financing in the future to meet any such unanticipated factors and a failure to obtain this necessary capital could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
−Removed: Since our foundation, we have invested a significant portion of our efforts and financial resources in research and development activities for our ChAdOx1, ChAdOx2 and MVA technologies, acquisition of additional complementary platforms such as SNAPvax, development of new technologies in house, and our product candidates derived from these technologies.
+Added: Since our foundation, we have invested a significant portion of our efforts and financial resources in research and development activities for our ChAdOx1, ChAdOx2 and MVA technologies, acquisition of additional complementary platforms such as VTP-1000 and VTP-1100, development of new technologies in house, and our product candidates derived from these technologies.
Preclinical studies and especially clinical trials and additional research and development activities will require substantial funds to complete.
2 unchanged sentences
In addition, other unanticipated costs may arise as outlined above.
−Removed: Because the outcome of any preclinical study or clinical trial is uncertain and the rate of change of third-party costs is also
−Removed: unpredictable, we cannot reasonably estimate now the actual amounts which will be necessary to complete the development and commercialization of our current or future product candidates successfully.
+Added: Because the outcome of any preclinical study or clinical trial is uncertain and the rate of change of third-party costs is also unpredictable, we cannot reasonably estimate now the actual amounts which will be necessary to complete the development and commercialization of our current or future product candidates successfully.
Our future capital requirements may depend on many factors, including:
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Unless and until we can generate a substantial amount of revenue from our product candidates, we expect to finance our future cash needs through public or private equity offerings, debt financings, collaborations, licensing arrangements or other sources, or any combination of the foregoing.
−Removed: Based on our research and development plans, we expect that our existing cash and cash equivalents, will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2025.
+Added: Based on our research and development plans, we expect that our existing cash and cash equivalents and other financial resources, will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2025.
These estimates are based on assumptions that may prove to be wrong, and we could use our available capital resources more quickly than we expect.
8 unchanged sentences
We have contingent payment obligations that we may incur upon achievement of clinical, regulatory and commercial milestones, as applicable, or royalty payments that we may be required to make under our licenses;
−Removed: however, the amount, timing and likelihood of such payments are not known as of June 30, 2023.
+Added: however, the amount, timing and likelihood of such payments are not known as of September 30, 2023.
Emerging Growth Company Status
5 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.