1 unchanged sentence
INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
−Removed: Condensed Consolidated Financial Statements (Unaudited)
+Added: Condensed Consolidated Financial Statements (Unaudited) Page
Condensed Consolidated Balance Sheets
Condensed Consolidated Statements of Operations and Comprehensive Loss
−Removed: Condensed Consolidated Statements of Changes in Shareholders’ Equity
+Added: Condensed Consolidated Statements of Changes in S tock holders’ Equity
Condensed Consolidated Statements of Cash Flows
3 unchanged sentences
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
−Removed: September 30,
−Removed: Current assets:
−Removed: Cash and cash equivalents
−Removed: Accounts receivable
−Removed: Accounts receivable - related parties
+Added: Cash, cash equivalents and restricted cash $ 129,971 $ 142,090
Research and development incentives receivable 5,196 4,908
1 unchanged sentence
Total current assets 143,131 156,905
+Added: Goodwill 12,209 12,209
Property and equipment, net 11,532 11,821
1 unchanged sentence
Right of use assets, net 7,408 7,581
−Removed: LIABILITIES AND SHAREHOLDERS’ EQUITY
+Added: Other assets 885 882
+Added: Total assets $ 199,482 $ 214,506
+Added: LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
1 unchanged sentence
Accrued expenses and other current liabilities 8,330 9,212
+Added: Deferred income 1,434 —
Operating lease liability - current 1,909 1,785
1 unchanged sentence
Non-Current liabilities:
−Removed: Operating lease liability
+Added: Operating lease liability - non-current 10,897 11,191
Contingent consideration 1,867 1,823
−Removed: Deferred tax liability, net
Other non-current liabilities 1,330 1,325
+Added: Deferred tax liability, net 537 574
Total liabilities $ 27,466 $ 27,511
Commitments and contingencies (Note 15)
−Removed: Shareholders’ equity:
+Added: Stockholders’ equity:
Ordinary shares, £ 0.000025 nominal value;
4 unchanged sentences
authorized, issued and outstanding:
−Removed: Deferred B shares, £ 0.01 nominal value;
−Removed: nil shares authorized, issued and outstanding (December 31, 2022:authorized, issued and outstanding :
−Removed: Deferred C shares, £ 0.000007 nominal value, nil shares authorized , issued and outstanding (December 31, 2022:
−Removed: authorized , issued and outstanding:
Additional paid-in capital 388,720 386,602
1 unchanged sentence
Accumulated other comprehensive loss – foreign currency translation adjustments ( 24,895 ) ( 23,315 )
−Removed: Total shareholders’ equity attributable to Barinthus Biotherapeutics plc shareholders
+Added: Total stockholders’ equity attributable to Barinthus Biotherapeutics plc shareholders 171,833 186,784
Noncontrolling interest 183 211
−Removed: Total shareholders’ equity
−Removed: Total liabilities and shareholders’ equity
−Removed: 1 indicates amount less than thousand
−Removed: The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
+Added: Total stockholders’ equity $ 172,016 $ 186,995
+Added: Total liabilities and stockholders’ equity $ 199,482 $ 214,506
+Added: The accompanying notes are an integral part of these condensed consolidated financial statements.
BARINTHUS BIOTHERAPEUTICS PLC
2 unchanged sentences
Three months ended
−Removed: Nine months ended
−Removed: September 30, 2023
−Removed: September 30, 2022
−Removed: September 30, 2023
−Removed: September 30, 2022
+Added: March 31, 2024 March 31, 2023
License revenue 1
−Removed: Research grants and contracts
Total revenue — 468
3 unchanged sentences
Total operating expenses 17,119 21,952
−Removed: (Loss)/income from operations
+Added: Other operating income 205 —
+Added: Loss from operations ( 16,914 ) ( 21,484 )
Other income/(expense):
2 unchanged sentences
Research and development incentives 594 1,157
−Removed: Other (expense)/ income, net
−Removed: Total other income /(expense)
−Removed: (Loss)/profit before income tax
−Removed: Net (loss)/income
+Added: Total other income, net 1,357 2,745
+Added: Loss before income tax ( 15,557 ) ( 18,739 )
+Added: Tax benefit 37 516
+Added: Net loss ( 15,520 ) ( 18,223 )
Net loss attributable to noncontrolling interest 31 43
−Removed: Net (loss)/income attributable to Barinthus Biotherapeutics plc shareholders
+Added: Net loss attributable to Barinthus Biotherapeutics plc shareholders ( 15,489 ) ( 18,180 )
Weighted-average ordinary shares outstanding, basic 38,773,482 38,013,399
Weighted-average ordinary shares outstanding, diluted 38,773,482 38,013,399
−Removed: Net (loss)/income per share attributable to ordinary shareholders, basic
−Removed: Net (loss)/income per share attributable to ordinary shareholders, diluted
−Removed: Net (loss)/income
+Added: Net loss per share attributable to ordinary shareholders, basic $ ( 0.40 ) $ ( 0.48 )
+Added: Net loss per share attributable to ordinary shareholders, diluted $ ( 0.40 ) $ ( 0.48 )
+Added: Net loss $ ( 15,520 ) $ ( 18,223 )
Other comprehensive (loss)/gain – foreign currency translation adjustments ( 1,577 ) 4,580
2 unchanged sentences
Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders $ ( 17,069 ) $ ( 13,606 )
−Removed: 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.
−Removed: The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
+Added: 1 Includes license revenue from related parties for the three months ended March 31, 2024 and 2023 of nil and $ 0.5 million, respectively.
+Added: The accompanying notes are an integral part of these condensed consolidated financial statements.
BARINTHUS BIOTHERAPEUTICS PLC
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
−Removed: SHAREHOLDERS’ EQUITY
+Added: STOCKHOLDERS’ EQUITY
(IN THOUSANDS, EXCEPT NUMBER OF SHARES)
−Removed: Three and Nine months ended September 30, 2023
−Removed: Total shareholders’
−Removed: equity attributable
−Removed: Ordinary Shares
−Removed: Deferred A Shares
−Removed: Deferred B Shares
−Removed: Deferred C Shares
−Removed: Comprehensive
−Removed: Biotherapeutics plc
−Removed: Noncontrolling
−Removed: Shareholders’
+Added: Three months ended March 31, 2024
+Added: Ordinary Shares Deferred A Shares
+Added: Shares Amount Shares Amount Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive Loss Total stockholders’ equity attributable to Barinthus Biotherapeutics plc stockholders Non-Controlling Interest Total Stockholders' Equity
Balance, January 1, 2024 38,643,540 $ 1 63,443 $ 86 $ 386,602 $ ( 176,590 ) $ ( 23,315 ) $ 186,784 $ 211 $ 186,995
Share based compensation — — — — 1,615 — — 1,615 — 1,615
−Removed: Issue of ordinary shares, net of issuance cost
−Removed: Foreign currency translation adjustments
−Removed: Cancellation of deferred shares
−Removed: ( 27,828,231 )
−Removed: Balance, March 31, 2023
−Removed: Share based compensation
−Removed: Issue of ordinary shares, net of issuance cost
−Removed: Foreign currency translation adjustments
−Removed: Balance, June 30, 2023
−Removed: Share based compensation
Issue of ordinary shares, net of issuance costs 309,416 0 1 — — 503 — — 503 — 503
Foreign currency translation adjustments — — — — — — ( 1,580 ) ( 1,580 ) 3 ( 1,577 )
−Removed: Balance, September 30, 2023
−Removed: Three and Nine months ended September 30, 2022
−Removed: Total shareholders’
−Removed: Equity attributable
−Removed: Ordinary Shares
−Removed: Deferred A Shares
−Removed: Deferred B Shares
−Removed: Deferred C Shares
−Removed: Comprehensive
−Removed: Biotherapeutics plc
−Removed: Noncontrolling
−Removed: Shareholders’
+Added: Net loss — — — — — ( 15,489 ) — ( 15,489 ) ( 31 ) ( 15,520 )
+Added: Balance, March 31, 2024 38,952,956 $ 1 63,443 $ 86 $ 388,720 $ ( 192,079 ) $ ( 24,895 ) $ 171,833 $ 183 $ 172,016
+Added: Three months ended March 31, 2023
+Added: Ordinary Shares Deferred A Shares Deferred B Shares Deferred C Shares
+Added: Shares Amount Shares Amount Shares Amount Shares Amount Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive Loss Total stockholders’ equity attributable to Barinthus Biotherapeutics plc stockholders Non-Controlling Interest Total Stockholders' Equity
Balance, January 1, 2023 37,683,531 $ 1 63,443 $ 86 570,987 $ 8 27,828,231 $ 0 1 $ 379,504 $ ( 103,243 ) $ ( 33,460 ) $ 242,896 $ 305 $ 243,201
Share based compensation — — — — — — — — 2,222 — — 2,222 — 2,222
−Removed: Issue of ordinary shares
+Added: Issue of ordinary shares, net of issuance costs 673,494 0 1 — — — — — — 1,789 — — 1,789 — 1,789
Foreign currency translation adjustments — — — — — — — — — — 4,574 4,574 6 4,580
+Added: Cancellation of deferred shares — — — — ( 570,987 ) ( 8 ) ( 27,828,231 ) 0 1 8 — — — — —
+Added: Net loss — — — — — — — — — ( 18,180 ) — ( 18,180 ) ( 43 ) ( 18,223 )
Balance, March 31, 2023 38,357,025 $ 1 63,443 $ 86 — $ — — $ — $ 383,523 $ ( 121,423 ) $ ( 28,886 ) $ 233,301 $ 268 $ 233,569
−Removed: Share based compensation
−Removed: Issue of ordinary shares
−Removed: Foreign currency translation adjustments
−Removed: Balance, June 30, 2022
−Removed: Share based compensation
−Removed: Issue of ordinary shares
−Removed: Foreign currency translation adjustments
−Removed: Balance, September 30, 2022
−Removed: 1 Indicates amount less than thousand
−Removed: The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
+Added: 1 Indicates amount less than one thousand
+Added: The accompanying notes are an integral part of these condensed consolidated financial statements
BARINTHUS BIOTHERAPEUTICS PLC
1 unchanged sentence
(IN THOUSANDS)
−Removed: Nine months ended
−Removed: September 30, 2023
−Removed: September 30, 2022
+Added: Three months ended
+Added: March 31, 2024 March 31, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:
−Removed: Net (loss)/income
+Added: Net loss ( 15,520 ) ( 18,223 )
Adjustments to reconcile net (loss)/income to net cash used in operating activities:
2 unchanged sentences
Non-cash lease expenses 359 279
−Removed: Unrealized foreign exchange loss/( gain)
−Removed: Non-cash interest expense
+Added: Unrealized foreign exchange (gain)/loss ( 1,026 ) 3,504
Change in contingent consideration 60 85
−Removed: Profit on sale of property and equipment
+Added: Non cash interest expense 12 —
Deferred tax benefit ( 37 ) ( 516 )
5 unchanged sentences
Accrued expenses and other current liabilities ( 823 ) ( 1,315 )
−Removed: Deferred revenue
+Added: Deferred income 1,434 —
+Added: Operating lease liabilities ( 346 ) —
+Added: Other assets — 123
Net cash used in operating activities ( 11,822 ) ( 3,174 )
1 unchanged sentence
Purchases of property and equipment ( 308 ) ( 2,507 )
−Removed: Proceeds from sale of property and equipment
Net cash used in investing activities $ ( 308 ) $ ( 2,507 )
CASH FLOWS FROM FINANCING ACTIVITIES:
−Removed: Issue of shares from the exercise of stock options
Proceeds from issue of ordinary shares, net of issuance costs 503 1,789
+Added: Issue of shares from the exercise of stock options 0 1
Payment of contingent consideration — ( 100 )
−Removed: Repayment of debt
−Removed: Net cash provided by/(used in) financing activities
−Removed: EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS
−Removed: Net decrease in cash and cash equivalents
−Removed: Cash and cash equivalents, beginning of the period
−Removed: Cash and cash equivalents, end of the period
+Added: Net cash provided by financing activities $ 503 $ 1,689
+Added: Effect of exchange rates on cash, cash equivalents and restricted cash ( 492 ) 935
+Added: Net decrease in cash, cash equivalents and restricted cash ( 12,119 ) ( 3,057 )
+Added: Cash, cash equivalents and restricted cash, beginning of the period 142,090 194,385
+Added: Cash, cash equivalents and restricted cash, end of the period $ 129,971 $ 191,328
Supplemental cash flow disclosures:
+Added: Cash paid for interest $ — $ 0 1
+Added: Cash paid for income taxes $ — $ 0 1
Non-Cash investing and financing activities
−Removed: Capital expenditures included in accounts payable and accrued expenses
−Removed: Right-of-use assets obtained in exchange for operating lease liabilities
+Added: Issue of ordinary shares $ — $ 0 1
+Added: Purchases of property and equipment included in accounts payable and accrued liabilities $ 95 $ 2,247
Asset retirement obligation $ — $ 282
Changes to right-of-use asset resulting from lease reassessment event $ — $ 4
−Removed: 1 Indicates amounts less than thousand
−Removed: The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
+Added: 1 Indicates amounts less than one thousand
+Added: The accompanying notes are an integral part of these condensed consolidated financial statements.
BARINTHUS BIOTHERAPEUTICS PLC
1 unchanged sentence
Nature of Business and Basis of Presentation
−Removed: Barinthus Biotherapeutics plc (formerly Vaccitech plc) is a public limited company incorporated pursuant to the laws of England and Wales in March 2021.
−Removed: 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.
−Removed: (formerly Vaccitech North America, Inc.), Barinthus Biotherapeutics Switzerland GmbH (formerly Vaccitech Switzerland GmbH) and Barinthus Biotherapeutics Italia S.R.L.
−Removed: (formerly Vaccitech Italia S.R.L.), are collectively referred to as the “Company” or “Barinthus Bio”.
+Added: Barinthus Biotherapeutics 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, Barinthus Australia Pty Limited, Vaccitech Oncology Limited (“VOLT”), Barinthus Biotherapeutics North America, Inc., Barinthus Biotherapeutics Switzerland GmbH and Barinthus Biotherapeutics S.R.L., are collectively referred to as the “Company” or “Barinthus Bio”.
The Company is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer.
The Company is headquartered in Harwell, Oxfordshire, United Kingdom.
−Removed: On November 6, 2023, the Company announced its renaming as Barinthus Bio to represent the evolution and expansion of its focus beyond vaccines.
−Removed: 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).
−Removed: 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.
−Removed: On April 4, 2022, a merger was effected between subsidiaries Vaccitech USA, Inc.
−Removed: and Barinthus Biotherapeutics North America, Inc., with Barinthus Biotherapeutics North America, Inc.
−Removed: being the surviving entity.
The Company operates in an environment of rapid technological change and substantial competition from pharmaceutical and biotechnology companies.
11 unchanged sentences
The condensed consolidated balance sheet as of December 31, 2023, was derived from the audited financial statements but does not contain all of the footnote disclosures from the annual financial statements.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 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.
−Removed: 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.
+Added: As of March 31, 2024, the Company had cash, cash equivalents and restricted cash of $ 130.0 million and an accumulated deficit of $ 192.1 million, and the Company expects to incur losses for the foreseeable future.
+Added: The Company expects that its cash, cash equivalents and restricted cash will be sufficient to fund current operations for at least the next twelve months from the issuance of the financial statements.
The Company expects to seek additional funding through equity financing, government or private-party grants, debt financings or other capital sources, including collaborations with other companies or other strategic transactions.
3 unchanged sentences
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.
−Removed: The condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, among other things, the realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business.
+Added: The unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, among other things, the realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Unaudited Condensed Financial Information
−Removed: 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.
+Added: The accompanying Condensed Consolidated Balance Sheets as of March 31, 2024, and December 31, 2023, the Condensed Consolidated Statements of Operations and Comprehensive Loss, Condensed Consolidated Statements of Changes in Stockholders’ Equity and the Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2024 and 2023 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, 2023, filed with the Securities Exchange Commission (the “Annual Report”) on March 20, 2024.
−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 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.
−Removed: 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.
+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 March 31, 2024, our results of operations for the three months ended March 31, 2024, and 2023, and our cash flows for the three months ended March 31, 2024, and 2023.
+Added: The results of operations for the three months ended March 31, 2024, are not necessarily indicative of the results to be expected for the year ending December 31, 2024, or any other interim periods.
Summary of Significant Accounting Policies
−Removed: The accounting policies of the Company are set forth in Note 2 to the consolidated financial statements as of and for the year ended December 31, 2022, except as discussed below related to newly adopted accounting pronouncements.
+Added: The accounting policies of the Company are set forth in Note 2 to the consolidated financial statements contained in the Annual Report, except as discussed below related to newly adopted accounting pronouncements.
Use of Estimates
6 unchanged sentences
Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements.
+Added: Segment information
+Added: Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker ("CODM"), the Company’s Chief Executive Officer, in making decisions regarding resource allocation and assessing performance.
+Added: The CODM approves key operating and strategic decisions, including key decisions in clinical development and clinical operating activities, entering into significant contracts and approves the Company's consolidated operating budget.
+Added: The Company views its operations and manages its business as one operating segment, the research and development of vaccines and immunotherapies.
+Added: As the Company operates in one operating segment, all required financial segment information can be found in these condensed consolidated financial statements.
BARINTHUS BIOTHERAPEUTICS PLC
2 unchanged sentences
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date.
−Removed: 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.
+Added: 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 period 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.
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 Transaction Gains/Losses in General and Administrative Expenses
−Removed: 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.
−Removed: 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.
−Removed: 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 nine months ended September 30, 2023, and 2022 (in thousands, except number of shares):
−Removed: Three months ended September 30,
−Removed: Nine months ended September 30,
−Removed: Net (loss)/income
+Added: Foreign Currency Translation in General and Administrative Expenses
+Added: The aggregate, net foreign exchange gain or loss recognized in general and administrative expenses for the three months ended March 31, 2024, was a gain of $ 1.2 million (three months ended March 31, 2023:
+Added: $ 3.5 million loss).
+Added: Net Loss Per Share
+Added: The following table sets forth the computation of basic and diluted net loss per share for the three months ended March 31, 2024, and 2023 (in thousands, except number of shares):
+Added: Three months ended March 31,
+Added: Net loss $ ( 15,520 ) $ ( 18,223 )
Net loss attributable to noncontrolling interest 31 43
−Removed: Net (loss)/income attributable to Barinthus Bio shareholders
+Added: Net loss attributable to Barinthus Biotherapeutics plc shareholders $ ( 15,489 ) $ ( 18,180 )
Weighted-average ordinary shares outstanding, basic 38,773,482 38,013,399
−Removed: Effect of dilutive stock options
Weighted-average ordinary shares outstanding, diluted 38,773,482 38,013,399
−Removed: Net (loss)/income per share attributable to ordinary shareholders, basic
−Removed: Net (loss)/income per share attributable to ordinary shareholders, diluted
−Removed: 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.
−Removed: 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.
−Removed: 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: Net loss per share attributable to ordinary shareholders, basic $ ( 0.40 ) $ ( 0.48 )
+Added: Net loss per share attributable to ordinary shareholders, diluted $ ( 0.40 ) $ ( 0.48 )
+Added: Since the Company was in a loss position for all periods presented, 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 March 31, 2024, 7,645,076 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 (March 31, 2023:
+Added: Property and Equipment, Net
+Added: During the three months ended March 31, 2024, the Company’s additions to property and equipment, net were $ 0.4 million which primarily related to an increase in leasehold improvements from the Company’s U.S.
+Added: office in Germantown, Maryland (three months ended March 31, 2023:
+Added: $ 4.8 million).
+Added: Depreciation expense for the three months ended March 31, 2024 was $ 0.6 million (three months ended March 31, 2023:
+Added: $ 0.4 million, respectively).
BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Property and Equipment, net
−Removed: 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.
−Removed: office in Germantown, Maryland (nine months ended September 30, 2022:
−Removed: $ 6.8 million, related to leasehold improvements of the Company’s corporate headquarters).
−Removed: Depreciation expense for the three and nine months ended September 30, 2023 was $ 0.7 million and $ 1.6 million, respectively (September 30, 2022:
−Removed: 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 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.
−Removed: 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:
−Removed: $ 0.8 million and $ 2.4 million, respectively).
+Added: The gross amount of amortizable intangible assets, consisting of acquired developed technology, was $ 31.6 million as of March 31, 2024 and December 31 2023, respectively, and accumulated amortization was $ 7.3 million and $ 6.5 million as of March 31, 2024 and December 31, 2023, respectively.
+Added: The amortization expense for the three months ended March 31, 2024 was $ 0.8 million (three months ended March 31, 2023:
+Added: $ 0.8 million).
The estimated annual amortization expense is $ 3.2 million for the years 2024 through to 2031.
Prepaid Expenses and Other Current Assets (in thousands):
−Removed: September 30,
+Added: 2024 December 31,
Prepayments and accrued income $ 5,093 $ 5,402
Value Added Tax receivable 1,196 3,031
−Removed: Lease incentive receivable
+Added: Other 1,675 1,474
+Added: Total $ 7,964 $ 9,907
Accrued Expenses and Other Current Liabilities (in thousands):
−Removed: September 30,
+Added: 2024 December 31,
Accrued manufacturing and clinical expenses $ 4,437 $ 4,003
−Removed: Accrued board of director compensation
Accrued bonus 660 2,412
2 unchanged sentences
Accrued other 1,033 1,066
+Added: Total $ 8,330 $ 9,212
+Added: Coalition for Epidemic Preparedness Innovations (“CEPI”) Funding Agreement
+Added: On December 20, 2023, Barinthus Biotherapeutics (UK) Limited (the “Company”), the Chancellors, Masters and Scholars of the University of Oxford (“Oxford,” together with the Company, the “Partners”) and the Coalition for Epidemic Preparedness Innovations (“CEPI”) entered into a Funding Agreement (the “Funding Agreement”) pursuant to which CEPI will provide funding of up to $ 34.8 million to the Company to advance the development of VTP-500, the Company’s vaccine candidate against Middle East Respiratory Syndrome (“MERS,” and such development activities, the “Project”).
+Added: In December 2023, VTP-500 received PRIME (PRIority MEdicines) designation by the European Medicines Agency.
+Added: Pursuant to the Funding Agreement, the Company has agreed to pay CEPI on a country-by-country basis increasing mid-single digit percentage royalties of net sales and net income with respect to future cash sales of VTP-500, less certain deductions, for a period starting on December 20, 2023 (“Effective Date”) and ending the later of:
+Added: (i) the expiration of the last valid patent claim included in intellectual property developed under the Project covering VTP-500 in such country, (ii) the expiration of Regulatory Exclusivity (as defined in the Funding Agreement) for VTP-500 in such country, and (iii) the tenth ( 10 th) anniversary of the first commercial sale of VTP-500 (the “Royalty Term”).
+Added: The Company shall also pay CEPI a mid-double digit percentage of net revenue earned on VTP-500 until CEPI has received payments from the Company under the Funding Agreement equaling the total amount of funding paid by CEPI to the Company and a low double-digit percentage of such net revenue thereafter.
+Added: Sales for the benefit of end users in specified low and middle income countries (“LMICs”) and upper and middle income countries (“UMICs”) are excluded from the calculations of net sales and net revenue.
+Added: Sales of product for the benefit of end users in LMICs and UMICs are subject to tiered discounted pricing requirements under the Funding Agreement.
+Added: The Company is further required to pay a mid-double digit percentage of any proceeds earned on any priority review voucher related to VTP-500 during the Royalty Period.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: For the period ended March 31, 2024, $ 1.6 million proceeds have been received and $ 0.2 million income has been recognized in relation to this contract.
+Added: This is presented as other operating income in the Statements of Operations and Comprehensive Loss.
+Added: The Funding Agreement cash payments are restricted as to the use and management of the funds.
+Added: The remaining unused amounts of the Funding Agreement cash payments of $ 1.4 million as at March 31, 2024 are reflected in Cash, cash equivalents and restricted cash in the condensed consolidated balance sheets until expenditures contemplated in the Funding Agreement are incurred.
+Added: Deferred income
+Added: Deferred income primarily relates to payments received from CEPI in advance of the eligible research and development expenses being incurred and are disclosed as deferred income separately in the condensed consolidated balance sheets.
+Added: Deferred income is released to the condensed consolidated statement of operations and comprehensive loss in the period in which such research and development activities are actually performed in a manner that satisfies the conditions of the Funding Agreement.
+Added: Changes in the deferred income during the three months ended March 31, 2024 and 2023, are as follows (in thousands):
+Added: Three Months Ended March 31,
+Added: Beginning balance $ — $ —
+Added: Cash payments received 1,629 —
+Added: Other income recognized related to the Funding Agreement ( 205 ) —
+Added: Foreign exchange translation 10 —
+Added: Ending balance $ 1,434 $ —
Ordinary Shares
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 September 30, 2023:
+Added: The following is a summary of the rights and privileges of the holders of ordinary shares as of March 31, 2024:
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.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Voting Rights:
7 unchanged sentences
, at least every five years ) to remain effective.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
On April 21, 2021, our shareholders approved the disapplication of preemptive rights for a period of five years from the date of approval by way of a special resolution of our shareholders.
4 unchanged sentences
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: The granting of this authority and the corresponding disapplication of preemptive rights was in addition to all subsisting authorities.
+Added: This disapplication will need to be renewed upon expiration ( i.e.
+Added: , at least every five years ) to remain effective, but may be sought more frequently for additional five-year terms (or any shorter period).
Deferred Shares
7 unchanged sentences
The Company’s deferred A shares with a nominal value of £ 1.00 each remain in issue for the purposes of satisfying the minimum share capital requirements for a public limited company as prescribed by the Companies Act 2006.
−Removed: The Company’s financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable, certain accrued expenses, and contingent consideration.
−Removed: 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 September 30, 2023, the Company had a contingent consideration liability of $ 1.8 million related to the acquisition of Avidea Technologies, Inc.
+Added: The Company’s financial instruments consist of cash, cash equivalents and restricted cash, accounts receivable, accounts payable, certain accrued expenses, and contingent consideration.
+Added: The carrying amounts of cash, cash equivalents and restricted cash, accounts receivable, accounts payable and accrued expenses approximated their respective fair value due to the short-term nature and maturity of these instruments.
+Added: As of March 31, 2024, the Company had a contingent consideration liability of $ 1.9 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.
3 unchanged sentences
The following table summarizes changes to our financial instruments carried at fair value and classified within Level 3 of the fair value hierarchy (in thousands):
−Removed: Three months ended
−Removed: Nine months ended
−Removed: September 30,
−Removed: September 30,
+Added: Three Months Ended March 31,
Beginning balance $ 1,823 $ 1,711
−Removed: Change in fair value recognized in net income/(loss) 1
+Added: Change in fair value recognized in net loss/(gain) 60 ( 38 )
Foreign exchange translation recognized in other comprehensive loss ( 16 ) 37
Ending balance $ 1,867 $ 1,710
−Removed: 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 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 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: Therefore, the Company performed an interim qualitative assessment as of March 31, 2024 to determine whether it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
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 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.
−Removed: 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: During the three month period ended March 31, 2024, 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 three months ended March 31, 2024, the Company granted 1,627,958 options to employees and directors with a weighted average grant date fair value of $ 2.90 and a weighted average exercise price of $ 3.67 per share (March 31, 2023:
granted 1,987,289 options, weighted average grant date fair value of $ 2.01 and a weighted average exercise price of $ 2.53 per share).
−Removed: For the nine months ended September 30, 2023, 664,449 options (September 30, 2022:
+Added: For the three months ended March 31, 2024, 70,946 options (March 31, 2023:
57,970 ) 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: Nine months ended
−Removed: September 30,
+Added: Three Months Ended March 31,
Expected volatility 108.8 % 97.4 %
2 unchanged sentences
Expected dividend yield — % — %
−Removed: As of September 30, 2023, 6,391,680 options with a weighted average exercise price of $ 8.86 were outstanding.
−Removed: 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.
−Removed: As of September 30, 2022, 4,976,180 options with a weighted average exercise price of $ 8.90 were outstanding.
−Removed: 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.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: As of March 31, 2024, 7,645,076 options with a weighted average exercise price of $ 6.20 were outstanding.
+Added: As of March 31, 2024, there was $ 6.2 million unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 1.9 years.
+Added: As of March 31, 2023, 6,807,859 options with a weighted average exercise price of $ 9.69 were outstanding.
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 September 30,
−Removed: Nine months ended September 30,
+Added: Three Months Ended March 31,
Research and development $ 712 $ 1,119
General and administrative 903 1,103
+Added: Total $ 1,615 $ 2,222
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Commitments and Contingencies
3 unchanged sentences
As part of execution of these arrangements, the Company paid certain upfront fees, which have been expensed as incurred because the developing technology has not yet reached technical feasibility, the lack of alternative use, and the lack of proof of potential value.
−Removed: The agreements cover a variety of fields, including influenza, cancer, human papillomavirus infection, (“HPV”), hepatitis B virus (“HBV”) and middle east respiratory syndrome (“MERS”).
+Added: The agreements cover a variety of fields, including influenza, cancer, human papillomavirus infection, (“HPV”), hepatitis B virus (“HBV”) and MERS.
The Company’s obligations for future payments under these arrangements are dependent on its ability to develop promising drug candidates, the potential market for these candidates and potential competing products, and the payment mechanisms in place in countries where the Company retains the right to sell.
1 unchanged sentence
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 nine month periods ended September 30, 2023 and 2022.
+Added: The Company has not made or accrued any material payments under these license agreements during the three month periods ended March 31, 2024 and 2023.
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: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The Company recorded a right-of-use asset and a lease liability on the effective date of the lease term.
The Company’s right-of-use asset and lease liability are as follows (in thousands):
−Removed: September 30,
+Added: 2024 December 31,
Right-of-use asset $ 7,408 $ 7,581
−Removed: Operating lease liability, current
−Removed: Operating lease liability, non-current
−Removed: Nine months ended September 30,
+Added: Lease liability, current 1,909 1,785
+Added: Lease liability, non-current 10,897 11,191
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Three months ended March 31,
Other information
−Removed: Operating cash flows used for operating leases
+Added: Operating cash flows from operating leases $ 346 $ 220
Weighted average remaining lease term (years) 8.71 9.71
Weighted average discount rate 7.5 % 7.6 %
−Removed: Three months ended September 30,
−Removed: Nine months ended September 30,
+Added: Three months ended March 31,
Short-term lease costs $ — $ 152
1 unchanged sentence
Total lease cost $ 359 $ 431
−Removed: Future annual minimum lease payments under operating leases as of September 30, 2023, were as follows (in thousands):
+Added: Future annual minimum lease payments under operating leases as of March 31, 2024, were as follows (in thousands):
Remainder of 2024 $ 1,430
+Added: Thereafter 7,974
Total minimum lease payments $ 17,257
imputed interest ( 4,451 )
−Removed: Total operating lease liability
+Added: Total lease liability $ 12,806
Other contingencies
2 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: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Related Party Transactions
−Removed: 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:
−Removed: $ Nil and $ 0.2 million respectively) to its shareholder, the University of Oxford, related to clinical study costs.
−Removed: As of September 30, 2023, the Company owed $ 0.1 million (December 31, 2022:
−Removed: $ Nil ) to the University of Oxford.
−Removed: 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:
−Removed: $ 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.
−Removed: As of September 30, 2023, the Company owed $ 0.2 million (December 31, 2022:
−Removed: $ Nil ) to Oxford University Innovation Limited.
−Removed: 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:
−Removed: $ 6.2 million and $ 38.2 million respectively), from Oxford University Innovation Limited.
−Removed: As of September 30, 2023, the Company was owed $ Nil (December 31, 2022:
+Added: During the three months ended March 31, 2024, the Company incurred expenses of $ 0.2 million (three months ended March 31, 2023:
+Added: $ 0.1 million) from Oxford University Innovation Limited which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford.
+Added: As of March 31, 2024, the Company owed $ 0.01 million (December 31, 2023:
+Added: $ 0.002 million) to Oxford University Innovation Limited.
+Added: During the three months ended March 31, 2024, the Company recognized license revenue of nil (three months ended March 31, 2023:
$ 0.5 million), from Oxford University Innovation Limited.
+Added: As of March 31, 2024, the Company was owed nil (December 31, 2023:
+Added: nil ) from Oxford University Innovation Limited.
Management ’ s Discussion and Analysis of Financial Condition and Results of Operations.
4 unchanged sentences
Helping patients and their families is the guiding principle at the heart of Barinthus Bio.
−Removed: The Company stands apart through its broad pipeline, built around four proprietary platform technologies;
+Added: We stand apart through our broad pipeline, built around four proprietary platform technologies;
two viral vector platforms, ChAdOx and MVA;
−Removed: and two synthetic SNAP platforms, SNAP-TI (SNAP-Tolerance Immunotherapy) and SNAP-CI (SNAP-Cancer Immunotherapy), previously referred to collectively as SNAPvax TM .
−Removed: 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: and two synthetic SNAP platforms, SNAP-Tolerance Immunotherapy, or SNAP-TI and SNAP-Cancer Immunotherapy, or SNAP-CI.
+Added: These platforms are enabling us to develop antigen-specific immunotherapeutic candidates designed to optimize the disease fighting capabilities of T cells and guide them towards a healthy balance.
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.
−Removed: 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:
−Removed: VTP-300, a Phase 2 immunotherapeutic candidate designed as a potential component of a functional cure for chronic hepatitis B viral (HBV) infection;
−Removed: VTP-200, a Phase 2 non-surgical product candidate for persistent high-risk human papillomavirus (HPV) with near term clinical read-outs;
+Added: Harnessing our range of proprietary viral vector and synthetic platform technologies, we are advancing a pipeline of four 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 infection;
+Added: VTP-200, a Phase 2 nonsurgical product candidate for persistent high-risk HPV;
VTP-1000, our first preclinical autoimmune candidate designed to utilize the SNAP-TI platform to treat patients with celiac disease;
−Removed: VTP-850, a second-generation Phase 2 immunotherapeutic candidate designed to treat recurrent prostate cancer;
−Removed: VTP-1100, our first preclinical cancer candidate, designed to utilize the SNAP-CI platform to treat patients with HPV-related cancer.
−Removed: 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).
−Removed: The Company also co-invented a COVID-19 vaccine with the University of Oxford, which has been exclusively licensed worldwide to AstraZeneca.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Prior to our IPO, we funded our operations primarily from private placements of our ordinary and preferred shares, private placements of loan notes convertible into ordinary shares, as well as from grants and licensing agreements, research tax credit payments, investments from non-controlling interest, and a $2.4 million upfront payment from OUI in July 2020 in connection with the Amendment, Assignment and Revenue Share Agreement, or the OUI License Agreement Amendment, related to the licensing of the COVID-19 vaccine, Vaxzevria.
−Removed: We do not expect to generate revenue from any of our own product candidates, excluding Vaxzevria, until we obtain regulatory authorization for one or more of such product candidates, if at all, and commercialize our products, or we enter into out-licensing agreements with third parties.
−Removed: On March 28, 2022, pursuant to the OUI License Agreement Amendment, we were notified of the commencement of payments, arising from AstraZeneca’s commercial sales of Vaxzevria.
−Removed: Under the terms of an exclusive worldwide license agreement between OUI and AstraZeneca, OUI is entitled to milestone payments and royalties on commercial sales of Vaxzevria that began after the pandemic period.
−Removed: 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 nine months ended September 30, 2023, we recognized $Nil and $0.8 million, respectively, as revenue (three and nine months ended September 30, 2022:
−Removed: $6.2 million and $38.2 million).
−Removed: 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.
+Added: and VTP-850, a second-generation Phase 2 immunotherapeutic candidate designed to treat recurrent prostate cancer.
+Added: Alongside these proprietary programs, we have partnerships in place to advance three additional prophylactic and therapeutic product candidates in Middle East Respiratory Syndrome, or MERS, Zoster and Non-Small Cell Lung Cancer, or NSCLC.
+Added: We also coinvented 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 our 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: We believe our proven scientific expertise, diverse portfolio and focus on product candidate development uniquely positions us to navigate towards delivering treatments for patients with infectious diseases, autoimmune-disorders and cancers that have a significant impact on their every day lives.
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 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.
+Added: As of March 31, 2024, we have sold 1,329,260 ordinary shares represented by ADSs under the sales agreement, amounting to net proceeds of $3.5 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 nine months ended September 30, 2023, we incurred a net loss of $56.2 million.
−Removed: 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.
+Added: For the year ended December 31, 2023, we generated a net loss of $73.4 million.
+Added: For the three months ended March 31, 2024, we incurred a net loss of $15.5 million.
+Added: As of March 31, 2024, we had an accumulated deficit of $192.1 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.
18 unchanged sentences
• effectively competing with other therapies.
−Removed: A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and/or timing associated with the development of that product candidate or could prevent continuation of that program being in the Company’s interests.
−Removed: For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we might be required to expend significant additional financial resources and time on the completion of clinical development.
−Removed: 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 September 30, 2023 will enable us to fund our operating expenses and capital requirements into the second quarter of 2025.
−Removed: Recent Developments
+Added: A change in the outcome of any of these or other variables with respect to the development of any of our current and future product candidates could significantly change the costs and timing associated with the development of that product candidate, in either direction.
+Added: Furthermore, our operating plans may change in the future owing to research outcomes or other opportunities, and we may need additional funds to meet operational needs and capital requirements associated with such altered operating plans.
+Added: Unless and until we can generate a substantial amount of revenue from our product candidates, if approved, we expect to finance our future cash needs through public or private equity offerings, debt financings, collaborations, licensing arrangements or other sources, or any combination of the foregoing.
+Added: Based on our research and development plans, we expect that our existing cash, cash equivalents and restricted cash and other financial resources, will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025.
+Added: 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.
+Added: If we raise additional funds through collaborations, strategic alliances, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us.
+Added: If we are unable to raise additional funds when needed, we would be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
+Added: Recent Development
These are estimated timelines only and our pipeline may be subject to change.
−Removed: General Meeting to Approve the Authorization to Allot Shares in the Company and Grant Subscription and Conversion Rights Free From Pre-Emption Rights
−Removed: 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.
−Removed: 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.
−Removed: Name Change to Barinthus Biotherapeutics plc
−Removed: On November 6, 2023, the Company announced its renaming as Barinthus Biotherapeutics plc to represent the evolution and expansion of its focus beyond vaccines.
−Removed: 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.
−Removed: 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.
−Removed: 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: Celiac disease
+Added: In April 2024, IND clearance was received from the FDA to progress VTP-1000 in a first in human clinical trial in Celiac disease.
+Added: GLU001 is a randomized, placebo-controlled Phase 1 trial with a controlled gluten challenge to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000 in adults with celiac disease.
+Added: The study is designed in two parts;
+Added: a single ascending dose part followed by a multiple ascending dose part, each randomized and placebo-controlled with three dose levels.
+Added: The primary endpoint is assessment of the safety and tolerability of single and multiple dosing, and determination of a dose and schedule for further investigation.
+Added: The trial also aims to demonstrate proof-of-principle of induction of immune tolerance and early proof-of-concept for VTP-1000 as a potential treatment for celiac disease based on assessment of pharmacodynamics and preliminary efficacy determined by means of a controlled gluten challenge.
+Added: This Phase 1 trial has also received Ethics Committee approval to proceed in Australia.
+Added: Topline Data from Phase 1b/2 APOLLO Trial of VTP-200 in Persistent High-Risk Human Papillomavirus ("hrHPV") Infections
+Added: On April 18, 2024, we announced topline final data from the APOLLO trial, (also known as HPV001) a Phase 1b/2 dose-ranging study of VTP-200 in women with low-grade cervical lesions associated with persistent hrHPV infection.
+Added: APOLLO was a randomized, placebo-controlled Phase 1b/2 multi-center trial of 108 participants across the UK and EU evaluating the safety, tolerability and immunogenicity of VTP-200 in women aged 25-55 with persistent hrHPV infection and low-grade cervical lesions.
+Added: The primary objective was to evaluate the safety and tolerability of VTP-200.
+Added: The trial was also designed to assess the effect of VTP-200 on clearance of hrHPV infection and cervical lesion(s), as well as select appropriate doses for further development.
+Added: The APOLLO study met its primary safety endpoint, demonstrating that VTP-200 was generally well-tolerated and was administered with no treatment-related grade 3 or higher unsolicited AEs and no treatment-related SAEs.
+Added: The highest hrHPV clearance rate of 60% at Month 12 was observed in group 2, which included the highest dose of ChAdOx, compared to a 33% clearance rate in the placebo group.
+Added: Groups 1, 3, 4 and 5 showed 12%, 11%, 33% and 36% hrHPV clearance rates, respectively.
+Added: The study also evaluated cervical lesion clearance rates in participants with both reported lesions at screening and visualization of the cervical transformation zone at 12 months (n=57).
+Added: The highest cervical lesion clearance rate of 67% was observed in group 2 and group 5, both received the highest dose of ChAdOx, compared to 39% in the placebo group.
+Added: Groups 1, 3 and 4 showed 40%, 20% and 33% cervical lesion clearance rates, respectively.
+Added: Pooled data from the five active dose groups showed no significant improvement in hrHPV clearance or cervical lesion clearance rates in comparison to the placebo group.
+Added: Future development options for the VTP-200 program are currently being evaluated with further analyses ongoing.
+Added: Management Team
+Added: On May 1, 2024, we announced the appointment of Dr.
+Added: Leon Hooftman as Chief Medical Officer.
+Added: Hooftman will join the company on June 3, 2024, and brings significant drug development expertise across a broad array of therapeutic areas including immunology, autoimmunity, hematology, oncology and infectious diseases.
+Added: VTP-300 interim data update at the European Association for the Study of the Liver ("EASL") Congress
+Added: On June 5-8, 2024, we will present interim data at the EASL Congress in Milan, Italy, following the acceptance of an abstract on HBV003, an ongoing Phase 2b trial designed to further evaluate the safety and efficacy of VTP-300 when combined with a low-dose anti-PD-1 antibody, and standard-of-care (SoC) nucleos(t)ide analogue (NUC) therapy.
+Added: An abstract has also been accepted at the EASL Congress for interim data from the Phase 2a AB-729-202 trial combining Arbutus Biopharma Corporation’s RNAi therapeutic candidate, imdusiran (AB-729), with Barinthus Bio’s T cell stimulating immunotherapeutic candidate, VTP-300, and SoC NUC therapy.
Impact of Israel and Gaza Conflict
−Removed: 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.
+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 our business, operations and financial condition will be minimal.
Impact of the Ukraine Crisis
−Removed: 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.
+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 our business, operations and financial condition will be minimal.
Impact of Global Economic Conditions and Inflationary Pressures
−Removed: Instability in global economic conditions and geopolitical matters, as well as volatility in financial markets, could have a material adverse effect on the Company’s results of operations and financial condition.
+Added: Instability in global economic conditions and geopolitical matters, as well as volatility in financial markets, could have a material adverse effect on our results of operations and financial condition.
These inflationary pressures and rising interest rates in the United States, the United Kingdom and elsewhere have given rise to increasing concerns that the U.S., U.K.
7 unchanged sentences
Under this agreement, we are entitled to receive from OUI a share of payments, including royalties and milestones, received by OUI from AstraZeneca in respect of this vaccine.
−Removed: 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 nine months ending September 30, 2023 was $Nil and $0.8 million, respectively (three and nine months ending September 30, 2022:
−Removed: $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.
−Removed: 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.
−Removed: Accordingly, we plan to recognize these and any future amounts as revenue when earned, and it is probable that a significant reversal of revenue will not occur.
+Added: In March 2022, we were notified by OUI of the commencement of revenue relating to commercial sales of Vaxzevria.
+Added: Our revenue for the three months ending March 31, 2024 was nil (three months ending March 31, 2023:
+Added: $0.5 million), 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.
+Added: In May 2024, AstraZeneca announced its planned withdrawal of Vaxzevria as demand had declined, and therefore we do not expect to receive any significant future revenue relating to commercial sales of Vaxzevria.
Operating Expenses
1 unchanged sentence
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 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.
+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, and VTP-1000 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 contract research organizations (“CRO”);
+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, or CROs;
• the cost of manufacturing drug products for use in preclinical development and clinical trials, including agreements with third parties, such as contract manufacturing organizations, consultants and contractors;
4 unchanged sentences
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.
−Removed: 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.
−Removed: We expect our general and administrative expenses to continue to increase in the future as we expand our operating activities in both the United Kingdom and United States and potentially prepare for manufacturing and/or commercialization of our current and future product candidates.
+Added: When determining the fair value of contingent consideration, significant judgment is used to determine the probability of success of achievement of the technology and clinical milestones and the date of the expected milestone.
+Added: We expect our general and administrative expenses to continue
+Added: to increase in the future as we expand our operating activities in both the United Kingdom and United States and potentially prepare for manufacturing and/or commercialization of our current and future product candidates.
These costs will increase as our headcount rises to allow full support for our operations as a public company, including increased expenses related to legal, accounting, regulatory and tax-related services associated with maintaining compliance with requirements of the Nasdaq Global Market and the Securities and Exchange Commission, directors’ and officers’ liability insurance premiums and investor relations activities.
+Added: Other Operating Income
+Added: Other operating incomes include the CEPI Funding Agreement pursuant to which CEPI will provide funding to us to advance the development of VTP-500, our vaccine candidate against MERS.
+Added: When there is reasonable assurance that we will comply with the conditions attached to a received grant, and when there is reasonable assurance that the grant will be received, grant income is recognized as other operating income on a gross basis in the condensed consolidated statements of operations and comprehensive loss on a systematic basis over the periods in which we recognize expenses for the related costs for which the grants are intended to compensate.
+Added: Payments received in advance of incurring reimbursable expenses are recorded as deferred income.
+Added: Any remaining unused amounts of the cash payments received on the balance sheet will be disclosed as restricted cash in the notes of the financial statement.
Other Income/(Expense)
1 unchanged sentence
Interest income results primarily from the interest earned on our short-term cash deposits and cash balances held by Barinthus Biotherapeutics (UK) Limited.
+Added: Interest Expense
+Added: Interest expense results primarily from the asset retirement obligation discounted over the length of the relevant lease.
Research and Development Incentives
1 unchanged sentence
We account for such relief received as other income.
−Removed: 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: 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.
+Added: We benefit from the United Kingdom research and development tax credit regime, being the Small and Medium-sized Enterprises R&D tax relief program, or SME Program, and, to the extent that our projects are grant funded or relate to work subcontracted to us by third parties, the Research and Development Expenditure Credit program, or RDEC Program.
+Added: Until March 2023 under the SME program, we were 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.
−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.
−Removed: 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.
−Removed: In addition, the EU State Aid cap limits the total aid claimable in respect of a given project to €7.5 million which may impact the Company’s ability to claim R&D tax credits in future.
+Added: From April 2023, under the SME Program, the enhanced rate of deduction has decreased from 230% to 186%, the SME credit rate has been reduced from 14.5% to 10% (except for R&D intensive SMEs, which will benefit from a credit rate of 14.5%), and our SME cash rebate has been reduced from an effective rate of 33.35% to 18.6% (or 26.97% for R&D intensive SMEs) and from 21.67% to 12.1% for subcontractors.
+Added: We are assessing if we can claim under the loss-making R&D Intensive Scheme for SMEs, which will provide benefits consistent with those claimed under the current SME Programs.
+Added: We may not be able to continue to claim research and development tax credits under the SME program in the future because we may no longer qualify as a small or medium-sized company.
+Added: In addition, the EU State Aid cap limits the total aid claimable in respect of a given project to €7.5 million which may impact our ability to claim R&D tax credits in future.
Further, the U.K.
−Removed: Finance Act of 2021 introduced a cap on payable credit claims under the SME Program in excess of £20,000 with effect from April 2021 by reference to, broadly, three times the total Pay As You Earn, or PAYE, and National Insurance Contributions, or NICs, liability of the Company, subject to an exception which prevents the cap from applying.
−Removed: That exception requires the Company to be creating, taking steps to create or managing intellectual property, as well as having qualifying research and development expenditure in respect of connected parties, which does not exceed 15% of the total claimed.
+Added: Finance Act of 2021 introduced a cap on payable credit claims under the SME Program in excess of
+Added: £20,000 with effect from April 2021 by reference to, broadly, three times our the total Pay As You Earn, or PAYE, and National Insurance Contributions, or NICs, liability, subject to an exception which prevents the cap from applying.
+Added: That exception requires us to create, take steps to create or manage intellectual property, as well as having qualifying research and development expenditure in respect of connected parties, which does not exceed 15% of the total claimed.
If such an exception does not apply, this could restrict the amount of payable credit that we claim.
2 unchanged sentences
Critical Accounting Policies and Use of Estimates
−Removed: 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, income and expenses during the reporting period.
−Removed: 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.
+Added: This discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP.
+Added: The preparation of financial statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue, income and expenses during the reporting period.
+Added: On an ongoing basis, management evaluates its estimates, including those related to fair value of contingent consideration and impairment of goodwill and intangible assets.
Management bases its estimates on historical experience and on various other market specific and relevant assumptions that management believes to be reasonable under the circumstances.
Actual results could differ from those estimates.
−Removed: 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: Research and Development Costs
−Removed: 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,
−Removed: 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.
−Removed: Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses.
−Removed: The prepaid amounts are then expensed as the related goods are delivered or the services are performed.
−Removed: Research and development costs are accrued when the related services or goods are delivered ahead of being billed.
−Removed: 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.
−Removed: Incremental sublicense fees triggered by contracts with customers are capitalized and expensed as research and development expenses over the period in which the relating revenue is recognized.
−Removed: Share-based Compensation
−Removed: We grant options to employees and directors and account for share-based compensation using a fair value method.
−Removed: All of these arrangements are settled in equity at a predetermined price and generally vest over a period of three years.
−Removed: All share options have a life of 10 years before expiration.
−Removed: 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 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.
−Removed: 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.
−Removed: 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.
−Removed: Share based compensation awards are measured at the grant date fair value.
−Removed: For service-based awards, compensation expense is generally recognized over the requisite service period of the awards, usually the vesting period.
−Removed: We apply the “multiple option” method of allocating expense.
−Removed: In applying this method, each vesting tranche of an award is treated as a separate grant and recognized on a straight-line basis over that tranche’s vesting period.
−Removed: 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 when they occur.
−Removed: Any differences in compensation recognized at the time of forfeiture are recorded as a cumulative adjustment in the period where the forfeiture occurs.
−Removed: We measure share-based awards granted to employees and directors based on the fair value on the date of grant using the Black-Scholes option-pricing model for options.
−Removed: Black-Scholes utilizes assumptions related to expected term, volatility, the risk-free interest rate and the dividend yield (which is assumed to be zero, as we have not paid any cash dividends).
−Removed: 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 nine months ended September 30, 2023 and 2022 were:
−Removed: September 30, 2023
−Removed: September 30, 2022
−Removed: Expected volatility
−Removed: Expected term (years)
−Removed: Risk-free interest rate
−Removed: Expected dividend yield
−Removed: 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.
−Removed: Business Combinations
−Removed: 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
−Removed: 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.
−Removed: As the “screen test” was not met, as the identifiable assets were not substantially all of the fair value of the gross assets acquired, we then applied the “framework” for determining whether the acquired assets included at minimum, an input and substantive process that together significantly contribute to the ability to create output.
−Removed: We concluded that the framework criteria are met because the scientists make up an organized workforce that has the necessary skills, knowledge, or experience to perform processes that when applied to the developed technology (input) is critical to the ability to undertake research and development of a product that can be provided to a customer.
−Removed: The more than-insignificant amount of goodwill (including the fair value associated with the workforce) was also an indicator that management considered in determining that the workforce is performing a critical process.
−Removed: We therefore determined the acquisition to meet the definition of a business combination.
−Removed: We recognize tangible and identifiable intangible assets acquired and liabilities assumed at their estimated fair values as of the acquisition date.
−Removed: Any excess purchase price over the estimated fair value assigned to the net tangible and identifiable intangible assets acquired and liabilities is allocated to goodwill.
−Removed: 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 combination of cash and ADSs, upon the achievement of certain milestones.
−Removed: 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 general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss.
−Removed: 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.
−Removed: Transaction costs are expensed as incurred in general and administrative expenses.
−Removed: Results of operations and cash flows of acquired companies are included in our operating results from the date of acquisition.
−Removed: Goodwill and Purchased Intangible Asset
−Removed: We test goodwill for impairment at least annually or more frequently if events or changes in circumstances indicate that the carrying amount of goodwill may not be recoverable.
+Added: We believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our financial statements and understanding and evaluating our reported financial results.
+Added: We assess goodwill for impairment at least annually or more frequently if events or changes in circumstances indicate that the carrying amounts may not be recoverable.
We have elected to assess goodwill for impairment by first performing a qualitative assessment to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount as a basis of determining whether it is necessary to perform the quantitative goodwill impairment test.
3 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 September 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 third quarter of 2023.
−Removed: 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.
−Removed: 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.
+Added: The goodwill of $12.2 million recognized as of March 31, 2024 related to the acquisition of Avidea on December 10, 2021.
+Added: We performed an interim assessment as of March 31, 2024 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 on this assessment, we have not recognized any impairment losses related to goodwill for the three months ending March 31, 2024.
+Added: Long-lived assets
+Added: The Company reviews long-lived assets to be held and used, including property and equipment, intangible assets and operating lease right-of-use assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable.
+Added: Evaluation of recoverability is first based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset group and its eventual disposition.
+Added: In the event such cash flows are not expected to be sufficient to recover the carrying amount of the asset or asset group, the assets are written down to their estimated fair values.
+Added: No such impairments were recorded during the three months ended March 31, 2024.
+Added: Contingent consideration
+Added: We recognize a contingent consideration liability related to the acquisition of Avidea.
+Added: The liability is remeasured to fair value at each reporting date until the contingency is resolved.
+Added: The fair value of the contingent consideration is a Level 3 valuation determined using significant unobservable inputs being the probability of success of achievement of the milestones and the expected date of the milestone achievement.
+Added: Changes in fair value are recognized in general and administrative expenses in the condensed consolidated statement of operations and comprehensive loss.
+Added: 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.
+Added: 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.
+Added: Changes in fair value are recognized in general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss.
+Added: The fair value of contingent consideration is based on the probability of pursuit of the activity associated with the milestone, the probability of success of the achievement of the milestone, the expected date of milestone achievement and applying the relevant discount rate.
Results of Operations
−Removed: Comparison of the Three Months Ended September 30, 2023 and 2022
−Removed: The following table sets forth the significant components of our results of operations (in thousands):
−Removed: ended September
−Removed: ended September
−Removed: Revenue from Licenses, Grants & Services
−Removed: Operating expenses:
−Removed: Research & development
−Removed: General and administrative
−Removed: Total operating expenses
−Removed: (Loss)/income from operations
−Removed: Other income (expense)
−Removed: Interest income
−Removed: Interest expense
−Removed: Research and development incentives
−Removed: Other expense
−Removed: Total other income
−Removed: (Loss)/profit before income tax
−Removed: Net (loss)/income
−Removed: 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.
−Removed: 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.
−Removed: Research and Development Expenses
−Removed: The following table summarizes our research and development expenses for the three months ended September 30, 2023 and 2022 (in thousands):
−Removed: ended September
−Removed: ended September
−Removed: Direct research and development expenses by program:
−Removed: VTP-600 NSCLC
−Removed: VTP-850 Prostate cancer
−Removed: VTP-1000/VTP-1100 Celiac/HPV Cancer
−Removed: Other and earlier stage programs
−Removed: Total direct research and development expenses
−Removed: Indirect research and development expenses:
−Removed: Personnel-related (including share-based compensation)
−Removed: Facility-related
−Removed: Other internal costs
−Removed: Total indirect research and development expenses
−Removed: Total research and development expenses
−Removed: Our research and development expenses for the three months ended September 30, 2023 and 2022 were $15.1 million and $9.7 million, respectively.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Indirect research and development expenses for the three months ended September 30, 2023 and 2022 were $3.5 million and $3.1 million, respectively.
−Removed: Of the $0.5 million increase, $0.3 million related to the increase in our research and development overhead costs.
−Removed: General and Administrative Expenses
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Interest Income
−Removed: 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.
−Removed: Research and Development Incentives
−Removed: For the three months ended September 30, 2023, research and development incentives were $1.2 million.
−Removed: 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 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.
−Removed: 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.
−Removed: Comparison of the Nine Months Ended September 30, 2023 and 2022
+Added: Comparison of the Three Months Ended March 31, 2024 and 2023
The following table sets forth the significant components of our results of operations (in thousands):
−Removed: ended September
−Removed: ended September
+Added: Three months ended March 31, 2024 Three months ended March 31, 2023 Change
Revenue from Licenses, Grants & Services $ — $ 468 $ (468)
3 unchanged sentences
Total operating expenses 17,119 21,952 (4,833)
−Removed: (Loss)/income from operations
+Added: Other operating income 205 — 205
+Added: Loss from operations
+Added: (16,914) (21,484) 4,570
Other income (expense)
3 unchanged sentences
Total other income 1,357 2,745 (1,388)
−Removed: (Loss)/profit before income tax
−Removed: Net (loss)/income
−Removed: 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.
−Removed: 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.
+Added: Loss before income tax
+Added: (15,557) (18,739) 3,182
+Added: Tax benefit 37 516 (479)
+Added: $ (15,520) $ (18,223) $ 2,703
+Added: For the three months ended March 31, 2024, and 2023, our revenue consisted of nil and $0.5 million respectively, from the OUI License Agreement Amendment with respect to payments from OUI in connection with commercial sales of Vaxzevria.
+Added: The decrease in revenue from the OUI License Agreement Amendment, compared to the prior period, resulted from substantially declined sales of Vaxzevria due to a decrease in demand.
+Added: In May 2024, AstraZeneca announced its planned withdrawal of Vaxzevria as demand had declined, and therefore we do not expect to receive any significant future revenue relating to commercial sales of Vaxzevria.
Research and Development Expenses
−Removed: The following table summarizes our research and development expenses for the nine months ended September 30, 2023 and 2022 (in thousands):
−Removed: ended September
−Removed: ended September
+Added: The following table summarizes our research and development expenses for the three months ended March 31, 2024 and 2023 (in thousands):
+Added: 31, 2024 Three months
+Added: 31, 2023 Change
Direct research and development expenses by program:
+Added: VTP-200 HPV $ 1,253 $ 1,338 $ (85)
+Added: VTP-300 HBV 1,913 2,118 (205)
+Added: VTP-500 MERS 1
VTP-600 NSCLC 2
+Added: 164 275 (111)
VTP-850 Prostate cancer 178 215 (37)
−Removed: VTP-1000/VTP-1100 Celiac/HPV Cancer
+Added: VTP-1000 Celiac 1,374 1,572 (198)
Other and earlier stage programs 3
3 unchanged sentences
Facility related 390 371 19
−Removed: Other internal costs
+Added: Other indirect costs 562 44 518
Total indirect research and development expenses 5,287 4,016 1,271
Total research and development expenses $ 11,125 $ 9,814 $ 1,311
−Removed: Our research and development expenses for the nine months ended September 30, 2023 and 2022 were $38.5 million and $30.2 million, respectively.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Indirect research and development expenses for the nine months ended September 30, 2023 and 2022 were $11.4 million and $8.7 million, respectively.
−Removed: 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.
+Added: 1 The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).
+Added: 2 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK.
+Added: Research and development expenses related to VTP-1100 HPV Cancer were previously included with VTP-1000 Celiac but are now included in 'Other and earlier stage programs' because we are focusing resources on other clinical programs and deferring the planned IND application for VTP-1100 in HPV cancer.
+Added: Our research and development expenses for the three months ended March 31, 2024 and 2023 were $11.1 million and $9.8 million, respectively.
+Added: Direct expenses for the three months ended March 31, 2024 and 2023 were $5.8 million and $5.8 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.
+Added: Of the $0.04 million increase, $0.5 million pertains to an increase in other and earlier stage programs mainly due to the reclassification of VTP-1100 HPV cancer cost in the current period to other earlier stage programs.
+Added: These increases were partially offset by $0.1 million decrease in VTP-200 HPV and $0.2 million for VTP-300 HBV due to a reduction in clinical trial and manufacturing development costs.
+Added: Indirect research and development expenses for the three months ended March 31, 2024 and 2023 were $5.3 million and $4.0 million, respectively.
+Added: Of the $1.3 million increase, $0.7 million related to an increase in headcount across locations in the United Kingdom and United States and $0.5 million increase in other indirect costs was primarily due to research and development overhead costs related to the new U.S.
+Added: laboratory and office facility that we relocated to in June 2023.
General and Administrative Expenses
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: General and administrative expenses for the three months ended March 31, 2024 and 2023 were $6.0 million and $12.1 million, respectively.
+Added: The decrease of $6.1 million relates primarily to a gain of $1.2 million on foreign exchange for the three months ended March 31, 2024, compared to a loss of $3.5 million for the three months ended March 31, 2023 a decrease in personnel expenses, including share-based payment charges of $0.8 million, primarily due to a reduction in non-cash share-based payment charges, and a decrease in insurance costs of $0.9 million due to a reduction in insurance premiums.
+Added: Other Operating Income
+Added: For the three months ended March 31, 2024 and 2023, other operating income was $0.2 million and nil, respectively, resulting from the funding provided by CEPI under the Funding Agreement, dated December 20, 2023, entered into by and among us, the Chancellors, Masters and Scholars of the University of Oxford and the CEPI in the three months ended March 31, 2024.
Interest Income
−Removed: 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.
+Added: For the three months ended March 31, 2024 and 2023, interest income was $0.8 million and $1.6 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 nine months ended September 30, 2023, research and development incentives were $2.9 million.
+Added: For the three months ended March 31, 2024 and 2023 research and development incentives were $0.6 million and $1.2 million, respectively.
Such research and development incentives relate to corporation tax relief on research and development projects incentive programs in the United Kingdom.
−Removed: 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.
−Removed: 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.
+Added: For the three months ended March 31, 2024 and 2023, the tax benefit was $0.04 million and $0.5 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 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.
−Removed: As of September 30, 2023, we had cash and cash equivalents of $160.3 million.
−Removed: Key financing and corporate milestones include the following:
−Removed: ● In March 2016, we raised gross proceeds of approximately $14.0 million from the issuance of our seed round of ordinary shares;
−Removed: ● Between November 2017 and December 2018, we raised gross proceeds of $33.9 million from the issuance of our series A shares;
+Added: Through March 31, 2024, we received gross proceeds of approximately $328.4 million from the issuance of our ordinary and preferred shares and convertible loan notes.
+Added: As of March 31, 2024, we had cash, cash equivalents and restricted cash of $130.0 million.
+Added: Recent financing and corporate milestones include the following:
• Between July 2020 and November 2020, we raised gross proceeds of $41.2 million from the issuance of convertible loan notes;
1 unchanged sentence
• 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 September 2023, we received $44.5 million of cash from OUI for the commercial sales of Vaxzevria;
−Removed: ● 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.
−Removed: 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.
+Added: • Between April 2022 and June 2023, we received $44.5 million of cash from OUI for the commercial sales of Vaxzevria;
+Added: • Between December 2022 and March 2024, we raised net proceeds of $3.5 million from the issuance of shares represented by ADSs through “at-the-market” offerings under the sales agreement with Jefferies LLC.
+Added: On August 9, 2022, we filed the Shelf, with the Securities and Exchange Commission in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million.
The Shelf was declared effective on August 17, 2022.
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 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.
+Added: As of March 31, 2024, we have sold 1,329,260 ordinary shares represented by ADSs under the sales agreement amounting to net proceeds of $3.5 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 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 immunotherapy platforms and our product candidates, including conducting ongoing research and development, preclinical studies, clinical trials, providing general and administrative support for these operations and developing our intellectual property portfolio.
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:
−Removed: ended September
−Removed: ended September
+Added: 31, 2024 Three months
+Added: ended March 31, 2023
Net cash used in operating activities $ (11,822) $ (3,174)
Net cash used in investing activities (308) (2,507)
−Removed: Net cash provided by/(used in) financing activities
−Removed: Effect of exchange rates on cash and cash equivalents
−Removed: Net (decrease)/increase in cash and cash equivalents
+Added: Net cash provided by financing activities 503 1,689
+Added: Effect of exchange rates on cash, cash equivalents and restricted cash (492) 935
+Added: Net decrease in cash, cash equivalents and restricted cash $ (12,119) $ (3,057)
Cash Used in Operating Activities
−Removed: 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.
−Removed: 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.
+Added: During the three months ended March 31, 2024, net cash used in operating activities was $11.8 million, primarily resulting from our net loss of $15.5 million adjusted by share based compensation of $1.6 million, depreciation and amortization of $1.4 million, non-cash lease expenses of $0.4 million, unrealized foreign exchange gain of $1.0 million and changes in our operating assets and liabilities, net of $1.3 million primarily related to a $1.9 million decrease in prepaid expenses and other current assets, $1.4 million increase in deferred revenue, a $0.8 million decrease in accrued expenses, $0.5 million decrease in accounts payable and $0.3 million decrease in operating lease liabilities.
+Added: During the three months ended March 31, 2023, net cash used in operating activities was $3.2 million, primarily resulting from our net loss of $18.2 million adjusted by share based compensation of $2.2 million, depreciation and amortization of $1.2 million, foreign exchange loss of $3.5 million, and changes in our operating assets and liabilities, net of $8.3 million.
Net Cash Used in Investing Activities
−Removed: 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.
−Removed: 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.
+Added: During the three months ended March 31, 2024 and 2023, cash used in investing activities was $0.3 million and $2.5 million, respectively.
+Added: These amounts resulted primarily from capital expenditures related to leasehold improvements on our new office in Germantown, Maryland, United States.
Net Cash Provided by/(Used in) Financing Activities
−Removed: 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.
−Removed: 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.
−Removed: Effect of exchange rates on cash and cash equivalents
−Removed: 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.
+Added: During the three months ended March 31, 2024 and 2023, cash provided by financing activities was $0.5 million and $1.7 million, respectively.
+Added: These amounts primarily related to net proceeds received from the issuance of ordinary shares through the “at-the-market” sales agreement.
+Added: Effect of exchange rates on cash, cash equivalents and restricted cash
+Added: During the three months ended March 31, 2024 and 2023, the effect of foreign exchange on cash, cash equivalents and restricted cash was a loss of $0.5 million and a gain of $1.0 million respectively, primarily as a result of fluctuations between the United States dollar and pound sterling exchange rates.
Future Funding Requirements
To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of our product candidates.
−Removed: 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 for the period ended September 30, 2023.
−Removed: As of September 30, 2023, we had an accumulated deficit of $159.3 million.
+Added: As a result, we have
+Added: incurred losses in each year since our inception in 2016, through to December 31, 2021.
+Added: We were profitable in 2022, however we have negative operating cash flows for the period ended March 31, 2024.
+Added: As of March 31, 2024, we had an accumulated deficit of $192.1 million.
We expect to continue to incur significant losses and negative cash flows from operations for the foreseeable future.
13 unchanged sentences
The size of our future net losses will depend on the rate of future growth of our expenses combined with our ability to generate revenue.
−Removed: Our prior losses and expected future losses have had and will continue to have an adverse effect on our shareholders’ equity and working capital unless and until eliminated by revenue growth.
+Added: Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital unless and until eliminated by revenue growth.
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 VTP-1000 and VTP-1100, 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 SNAP-TI and SNAP-CI, 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.
9 unchanged sentences
• the success of our collaborations with CanSino, CRUK and the Ludwig Institute and any future collaboration partners;
−Removed: ● the success of OUI’s licensed product candidate with AstraZeneca;
• our ability to establish and maintain collaborations, strategic licensing or other arrangements and the financial terms of such agreements;
6 unchanged sentences
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 and other financial resources, 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, cash equivalents and restricted cash and other financial resources, will enable us to fund our operating expenses and capital expenditure requirements into the fourth 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.
6 unchanged sentences
These contracts are generally cancellable by us upon prior notice.
−Removed: Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancellable obligations of our service providers, up to the date of cancellation.
+Added: Payments due upon
+Added: cancellation consist only of payments for services provided or expenses incurred, including noncancellable obligations of our service providers, up to the date of cancellation.
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 September 30, 2023.
+Added: however, the amount, timing and likelihood of such payments are not known as of March 31, 2024.
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.