3 unchanged sentences
Condensed Consolidated Balance Sheets
−Removed: Condensed Consolidated Statements of Operations and Comprehensive Loss
+Added: Condensed Consolidated Statements of Operations and Comprehensive Income
Condensed Consolidated Statements of Changes in Stockholders’ Equity
4 unchanged sentences
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
+Added: September 30,
Cash, cash equivalents and restricted cash $ 106,102 $ 142,090
+Added: Contract asset - related parties 14,969 —
Research and development incentives receivable 5,403 4,908
37 unchanged sentences
BARINTHUS BIOTHERAPEUTICS PLC
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
+Added: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
−Removed: Three months ended Six months ended
−Removed: June 30, 2024 June 30, 2023 June 30, 2024 June 30, 2023
+Added: Three months ended Nine months ended
+Added: September 30, 2024 September 30, 2023 September 30, 2024 September 30, 2023
License revenue 1
11 unchanged sentences
Research and development incentives 608 1,205 1,895 2,921
−Removed: Other income 20 310 20 310
+Added: Other income/(expense) 26 ( 2 ) 46 308
Total other income, net 1,248 1,392 3,941 5,514
10 unchanged sentences
Other comprehensive gain/(loss) – foreign currency translation adjustments 9,191 ( 7,820 ) 7,778 2,364
−Removed: Comprehensive loss ( 16,779 ) ( 18,220 ) ( 33,876 ) ( 31,863 )
+Added: Comprehensive income/(loss) 1,062 ( 21,930 ) ( 32,814 ) ( 53,793 )
Comprehensive loss attributable to noncontrolling interest 5 48 44 100
−Removed: Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders $ ( 16,768 ) $ ( 18,205 ) $ ( 33,837 ) $ ( 31,811 )
−Removed: 1 Includes license revenue from related parties for the three and six months ended June 30, 2024 of nil and for the three and six months ended June 30, 2023 of $ 0.3 million and $ 0.8 million, respectively.
+Added: Comprehensive income/(loss) attributable to Barinthus Biotherapeutics plc shareholders $ 1,067 $ ( 21,882 ) $ ( 32,770 ) $ ( 53,693 )
+Added: 1 Includes license revenue from related parties for the three and nine months ended September 30, 2024 of $ 15.0 million (three and nine months ended September 30, 2023:
+Added: nil and $ 0.8 million, respectively).
The accompanying notes are an integral part of these condensed consolidated financial statements.
3 unchanged sentences
(IN THOUSANDS, EXCEPT NUMBER OF SHARES)
−Removed: Three and Six months ended June 30, 2024
+Added: Three and Nine months ended September 30, 2024
Ordinary Shares Deferred A Shares
−Removed: 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
+Added: Shares Amount Shares Amount Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive (Loss)/Income 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
9 unchanged sentences
Balance, June 30, 2024 39,184,338 $ 1 63,443 $ 86 390,273 $ ( 209,010 ) $ ( 24,732 ) $ 156,618 $ 172 $ 156,790
−Removed: Three and Six months ended June 30, 2023
+Added: Share based compensation — — — — 1,144 — — 1,144 — 1,144
+Added: Issue of ordinary shares, net of issuance costs 358,180 0 1 — — 465 — — 465 — 465
+Added: Foreign currency translation adjustments — — — — — — 9,181 9,181 10 9,191
+Added: Net loss — — — — — ( 8,114 ) — ( 8,114 ) ( 15 ) ( 8,129 )
+Added: Balance, September 30, 2024 39,542,518 $ 1 63,443 $ 86 $ 391,882 $ ( 217,124 ) $ ( 15,551 ) $ 159,294 $ 167 $ 159,461
+Added: Indicates amount less than one thousand
+Added: The accompanying notes are an integral part of these condensed consolidated financial statements
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
+Added: STOCKHOLDERS’ EQUITY
+Added: (IN THOUSANDS, EXCEPT NUMBER OF SHARES)
+Added: Three and Nine months ended September 30, 2023
Ordinary Shares Deferred A Shares Deferred B Shares Deferred C Shares
−Removed: 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
+Added: Shares Amount Shares Amount Shares Amount Shares Amount Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive (Loss)/Income 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
10 unchanged sentences
Balance, June 30, 2023 38,524,059 $ 1 63,443 $ 86 — $ — — $ — $ 385,636 $ ( 145,225 ) $ ( 23,289 ) $ 217,209 $ 253 $ 217,462
+Added: Share based compensation — — — — — — — — 57 — — 57 — 57
+Added: Issue of ordinary shares, net of issuance costs 22,535 0 1 — — — — — — 14 — — 14 — 14
+Added: Foreign currency translation adjustments — — — — — — — — — — ( 7,810 ) ( 7,810 ) ( 10 ) ( 7,820 )
+Added: Net loss — — — — — — — — — ( 14,072 ) — ( 14,072 ) ( 38 ) ( 14,110 )
+Added: Balance, September 30, 2023 38,546,594 $ 1 63,443 $ 86 — $ — — $ — $ 385,707 $ ( 159,297 ) $ ( 31,099 ) $ 195,398 $ 205 $ 195,603
1 Indicates amount less than one thousand
3 unchanged sentences
(IN THOUSANDS)
−Removed: Six months ended
−Removed: June 30, 2024 June 30, 2023
+Added: Nine months ended
+Added: September 30, 2024 September 30, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ ( 40,592 ) $ ( 56,157 )
−Removed: Adjustments to reconcile net (loss)/income to net cash used in operating activities:
+Added: Adjustments to reconcile net loss to net cash used in operating activities:
Share based compensation 3,954 4,269
1 unchanged sentence
Non-cash lease expenses 1,086 787
−Removed: Unrealized foreign exchange (gain)/loss ( 583 ) 7,122
+Added: Unrealized foreign exchange loss 2,022 879
Change in contingent consideration ( 306 ) 86
2 unchanged sentences
Changes in operating assets and liabilities:
−Removed: Accounts receivable (including related parties) — 5,606
+Added: Contract asset (including related parties) ( 14,969 ) 5,800
Prepaid expenses and other current assets 2,083 5,249
20 unchanged sentences
Non-cash investing and financing activities:
−Removed: Purchases of property and equipment included in accounts payable and accrued liabilities $ — $ 506
Asset retirement obligation $ — $ 287
6 unchanged sentences
Barinthus Biotherapeutics 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, 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 and autoimmunity.
+Added: Barinthus Biotherapeutics plc and its direct and indirect subsidiaries, Barinthus Biotherapeutics (UK) Limited, Barinthus Biotherapeutics 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 and autoimmunity.
The Company is headquartered in Harwell, Oxfordshire, United Kingdom.
12 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: As of June 30, 2024, the Company had cash, cash equivalents and restricted cash of $ 117.8 million and an accumulated deficit of $ 209.0 million, and the Company expects to incur losses for the foreseeable future.
+Added: As of September 30, 2024, the Company had cash, cash equivalents and restricted cash of $ 106.1 million and an accumulated deficit of $ 217.1 million, and the Company expects to incur losses for the foreseeable future.
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.
8 unchanged sentences
Unaudited Condensed Consolidated Financial Information
−Removed: The accompanying Condensed Consolidated Balance Sheets as of June 30, 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 and six months ended June 30, 2024 and 2023 are unaudited.
+Added: The accompanying Condensed Consolidated Balance Sheets as of September 30, 2024, and December 31, 2023, the Condensed Consolidated Statements of Operations and Comprehensive Income, Condensed Consolidated Statements of Changes in Stockholders’ Equity and the Condensed Consolidated Statements of Cash Flows for the three and nine months ended September 30, 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 June 30, 2024, our results of operations for the three and six months ended June 30, 2024, and 2023, and our cash flows for the six months ended June 30, 2024, and 2023.
−Removed: The results of operations for the three and six months ended June 30, 2024, are not necessarily indicative of the results to be expected for the year ending December 31, 2024, or any other interim periods.
+Added: In our opinion, the unaudited condensed consolidated financial statements include all adjustments of a normal recurring nature necessary for the fair presentation of our financial position as of September 30, 2024, our results of operations for the three and nine months ended September 30, 2024, and 2023, and our cash flows for the nine months ended September 30, 2024, and 2023.
+Added: The results of operations for the three and nine months ended September 30, 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
11 unchanged sentences
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.
−Removed: The Company views its operations and manages its business as one operating segment, the research and development of vaccines and immunotherapies.
−Removed: The chief operating decision maker uses net loss to monitor budget versus actual results and decide how to use the Company's resources.
+Added: The Company views its operations and manages its business as one operating segment, the research and development of immunotherapies and vaccines.
+Added: The chief operating decision maker uses loss before income tax to monitor budget versus actual results and decide how to use the Company's resources.
As the Company operates in one operating segment, all required financial segment information can be found in these condensed consolidated financial statements.
6 unchanged sentences
Foreign Currency Translation in General and Administrative Expenses
−Removed: The aggregate, net foreign exchange gain or loss recognized in general and administrative expenses for the three and six months ended June 30, 2024, was a loss of $ 0.1 million and gain of $ 1.1 million, respectively (three and six months ended June 30, 2023:
−Removed: $ 4.2 million loss and $ 7.7 million loss, respectively).
+Added: The aggregate, net foreign exchange gain or loss recognized in general and administrative expenses for the three and nine months ended September 30, 2024, was a loss of $ 7.7 million and loss of $ 6.6 million, respectively (three and nine months ended September 30, 2023:
+Added: $ 6.6 million gain and $ 1.1 million loss, respectively).
Net Loss Per Share
−Removed: The following table sets forth the computation of basic and diluted net loss per share for the three and six months ended June 30, 2024, and 2023 (in thousands, except number of shares):
−Removed: Three months ended June 30, Six months ended June 30,
+Added: The following table sets forth the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2024, and 2023 (in thousands, except number of shares):
+Added: Three months ended September 30, Nine months ended September 30,
2024 2023 2024 2023
7 unchanged sentences
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.
−Removed: As of June 30, 2024, 7,779,884 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 (June 30, 2023:
+Added: As of September 30, 2024, 7,340,000 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 (September 30, 2023:
BARINTHUS BIOTHERAPEUTICS PLC
1 unchanged sentence
Property and Equipment, Net
−Removed: During the six months ended June 30, 2024, the Company’s additions to property and equipment, net were $ 0.5 million which primarily related to an increase in lab equipment in the Company's U.K.
−Removed: office (six months ended June 30, 2023:
−Removed: $ 6.4 million, primarily related to an increase in leasehold improvements from the Company’s U.S.
+Added: During the nine months ended September 30, 2024, the Company’s additions to property and equipment, net were $ 0.6 million which primarily related to an increase in lab equipment in the Company's U.K.
+Added: office (nine months ended September 30, 2023:
+Added: $ 5.9 million, primarily related to an increase in leasehold improvements for the Company’s U.S.
office in Germantown, Maryland).
−Removed: Depreciation expense for the three and six months ended June 30, 2024 was $ 0.7 million and $ 1.3 million, respectively (June 30, 2023:
−Removed: three and six months $ 0.5 million and $ 0.9 million, respectively).
+Added: Depreciation expense for the three and nine months ended September 30, 2024 was $ 0.7 million and $ 2.0 million, respectively (September 30, 2023:
+Added: three and nine months $ 0.7 million and $ 1.6 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 June 30, 2024 and December 31 2023, respectively, and accumulated amortization was $ 8.1 million and $ 6.5 million as of June 30, 2024 and December 31, 2023, respectively.
−Removed: The amortization expense for the three and six months ended June 30, 2024 was $ 0.8 million and $ 1.6 million, respectively (three and six months ended June 30, 2023:
+Added: The gross amount of amortizable intangible assets, consisting of acquired developed technology, was $ 31.6 million as of September 30, 2024 and December 31, 2023, respectively, and accumulated amortization was $ 8.9 million and $ 6.5 million as of September 30, 2024 and December 31, 2023, respectively.
+Added: The amortization expense for the three and nine months ended September 30, 2024 was $ 0.8 million and $ 2.4 million, respectively (three and nine months ended September 30, 2023:
$ 0.8 million and $ 2.4 million, respectively).
2 unchanged sentences
Given this change in Company focus, management identified circumstances that could indicate that the carrying amount of the Company's intangible assets may not be recoverable.
−Removed: Therefore, the Company performed both a qualitative and quantitative assessment as of June 30, 2024 and determined that the carrying amount of the Company's intangible assets are recoverable.
+Added: Therefore, the Company performed both a qualitative and quantitative assessment in July 2024 and determined that the carrying amount of the Company's intangible assets are recoverable.
+Added: As of September 30, 2024, the Company did not identify any additional circumstances that may indicate the carrying amount of the Company's intangible assets are not recoverable.
Prepaid Expenses and Other Current Assets (in thousands):
+Added: September 30,
2024 December 31,
4 unchanged sentences
Accrued Expenses and Other Current Liabilities (in thousands):
+Added: September 30,
2024 December 31,
5 unchanged sentences
Total $ 7,966 $ 9,212
−Removed: 1 Included in Accrued other as of June 30, 2024 is a provision of $ 0.8 million for severance costs for the reduction in workforce following the Company’s announcement in June 2024 to prioritize its pipelin e.
−Removed: Of this expense, $ 0.7 million is included in research and development expenses and $ 0.1 million is included in general and administrative expenses in the statements of operations and comprehensive loss.
BARINTHUS BIOTHERAPEUTICS PLC
9 unchanged sentences
The Company is further required to pay a low to mid-double-digit percentage of any proceeds earned on any priority review voucher related to VTP-500 during the Royalty Period.
−Removed: During the six months period ended June 30, 2024, $ 1.6 million proceeds have been received and $ 0.8 million income has been recognized in relation to this contract.
−Removed: This is presented as other operating income in the condensed consolidated statements of operations and comprehensive loss.
+Added: During the nine months period ended September 30, 2024, $ 3.0 million proceeds have been received and $ 1.0 million income has been recognized in relation to this contract.
+Added: This is presented as other operating income in the condensed consolidated statements of operations and comprehensive income.
The Funding Agreement cash payments are restricted as to the use and management of the funds.
−Removed: The remaining unused amounts of the Funding Agreement cash payments of $ 0.8 million as of June 30, 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: The remaining unused amounts of the Funding Agreement cash payments of $ 2.0 million as of September 30, 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.
Deferred income
−Removed: 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.
−Removed: Deferred income is released to the condensed consolidated statements 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.
−Removed: Changes in deferred income during the three and six months ended June 30, 2024 and 2023, are as follows (in thousands):
−Removed: Three months ended June 30, Six months ended June 30,
+Added: Payments received from CEPI in advance of the eligible research and development expenses being incurred are disclosed as deferred income separately in the condensed consolidated balance sheets.
+Added: Deferred income is released to the condensed consolidated statements of operations and comprehensive income 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 deferred income during the three and nine months ended September 30, 2024 and 2023, are as follows (in thousands):
+Added: Three months ended September 30, Nine months ended September 30,
2024 2023 2024 2023
8 unchanged sentences
All ordinary shares rank pari passu as a single class.
−Removed: The following is a summary of the rights and privileges of the holders of ordinary shares as of June 30, 2024:
+Added: The following is a summary of the rights and privileges of the holders of ordinary shares as of September 30, 2024:
Liquidation preference:
1 unchanged sentence
The Company may, subject to the provisions of the Companies Act 2006 and our Articles, by ordinary resolution from time to time declare dividends to be paid to shareholders not exceeding the amount recommended by the Company’s board of directors.
−Removed: Subject to the provisions of the Companies Act 2006, in so far as, in the board of directors’ opinions, the Company’s profits justify such payments, the board of directors may pay interim dividends on the Company’s ordinary shares.
+Added: Subject to the provisions of the Companies Act 2006, insofar 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.
Voting Rights:
21 unchanged sentences
The deferred shares shall confer on the holders thereof no further right to participate in the assets of the Company.
−Removed: On March 29, 2023, all deferred B shares (nominal value of £ 0.01 each) and deferred C shares (nominal value of £ 0.00000736245954692556 each) previously in issue were transferred back to the Company and subsequently cancelled.
+Added: On March 29, 2023, all deferred B shares (nominal value of £ 0.01 each) and deferred C shares (nominal value of £ 0.00000736245954692556 each) previously in issue were transferred back to the Company and subsequently canceled.
These deferred shares had previously been issued to certain pre-IPO shareholders in connection with the implementation of certain stages of the Company’s pre-IPO share capital reorganization.
6 unchanged sentences
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.
−Removed: As of June 30, 2024, the Company had a contingent consideration liability of $ 1.9 million related to the acquisition of Avidea Technologies, Inc.
+Added: As of September 30, 2024, the Company had a contingent consideration liability of $ 1.6 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.
1 unchanged sentence
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 June 30, Six months ended June 30,
+Added: Three months ended September 30, Nine months ended September 30,
2024 2023 2024 2023
1 unchanged sentence
Change in fair value recognized in net loss ( 378 ) ( 244 ) ( 300 ) 72
−Removed: Foreign exchange translation recognized in other comprehensive loss 3 53 ( 13 ) 90
+Added: Foreign exchange translation recognized in other comprehensive income 100 ( 76 ) 87 14
Ending balance $ 1,610 $ 1,797 $ 1,610 $ 1,797
−Removed: 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, and the plans announced in June 2024 to prioritize its pipeline to focus on the development of VTP-300 for chronic Hepatitis B virus infection and VTP-1000 in celiac disease.
−Removed: Therefore, the Company performed both an interim qualitative and quantitative assessment as of June 30, 2024 to determine whether it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
−Removed: Based on this assessment, management determined it is not more likely than not that the fair value of the reporting unit is less than its carrying amount and hence no impairment loss has been recognized.
+Added: The Company has 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, and the plans announced in June 2024 to prioritize its pipeline to focus on the development of VTP-300 for chronic Hepatitis B virus infection and VTP-1000 in celiac disease.
+Added: Therefore, the Company performed both an interim qualitative and quantitative assessment in July 2024 to determine whether it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
+Added: The Company also performed an interim qualitative assessment as of September 30, 2024 and did not identify any additional circumstances that may indicate it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
+Added: Based on these assessments, management determined it is not more likely than not that the fair value of the reporting unit is less than its carrying amount as of September 30, 2024 and hence no impairment loss has been recognized.
Share-Based Compensation
−Removed: During the six month period ended June 30, 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.
−Removed: For the six months ended June 30, 2024, the Company granted 1,951,377 options to employees and directors with a weighted average grant date fair value of $ 2.71 and a weighted average exercise price of $ 3.41 per share (June 30, 2023:
−Removed: granted 2,142,905 options, weighted average grant date fair value of $ 2.00 and a weighted average exercise price of $ 2.51 per share).
−Removed: For the six months ended June 30, 2024, 229,430 options (June 30, 2023:
+Added: During the nine month period ended September 30, 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 nine months ended September 30, 2024, the Company granted 1,953,422 options to employees and directors with a weighted average grant date fair value of $ 2.71 per share and a weighted average exercise price of $ 3.41 per share (September 30, 2023:
+Added: granted 2,221,706 options, weighted average grant date fair value of $ 1.99 per share and a weighted average exercise price of $ 2.50 per share).
+Added: For the nine months ended September 30, 2024, 658,512 options (September 30, 2023:
664,449 ) were forfeited.
2 unchanged sentences
The fair value of each stock option issued to employees was estimated at the date of grant using the Black-Scholes model with the following weighted-average assumptions:
−Removed: Six months ended June 30,
+Added: Nine months ended September 30,
Expected volatility 108.7 % 96.9 %
2 unchanged sentences
Expected dividend yield — % — %
−Removed: As of June 30, 2024, 7,779,884 options with a weighted average exercise price of $ 6.19 were outstanding.
−Removed: As of June 30, 2024, there was $ 5.4 million unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 1.9 years.
−Removed: As of June 30, 2023, 6,781,099 options with a weighted average exercise price of $ 9.51 were outstanding.
−Removed: Share based compensation expense is classified in the unaudited condensed consolidated statements of operations and comprehensive loss as follows (in thousands):
−Removed: Three months ended June 30, Six months ended June 30,
+Added: As of September 30, 2024, 7,340,000 options with a weighted average exercise price of $ 6.03 per share were outstanding (September 30, 2023:
+Added: 6,391,680 options with a weighted average exercise price of $ 8.86 per share were outstanding).
+Added: As of September 30, 2024, there was $ 4.0 million unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 1.7 years.
+Added: Share based compensation expense is classified in the unaudited condensed consolidated statements of operations and comprehensive income as follows (in thousands):
+Added: Three months ended September 30, Nine months ended September 30,
2024 2023 2024 2023
11 unchanged sentences
The obligation to make these payments is contingent upon the Company’s ability to develop candidates for submission for phased testing and approvals, and for the development of markets for the products developed by the Company.
−Removed: The Company has not made or accrued any material payments under these license agreements during the six month periods ended June 30, 2024 and 2023.
+Added: The Company has not made or accrued any material payments under these license agreements during the nine month periods ended September 30, 2024 and 2023.
The Company leases certain laboratory and office space under operating leases, which are described below.
2 unchanged sentences
The property is the Company’s corporate headquarters.
−Removed: As the Company’s leases typically do not provide an implicit rate, the Company uses an estimate of its incremental borrowing rate based on the information available at the lease commencement date, being the rate incurred to borrow on a collateralized basis over a similar term at an amount equal to the lease payments in a similar economic environment.
−Removed: The Company has provided the lessor with a refundable security deposit of $ 0.7 million which is included in Other assets.
+Added: As the Company’s leases typically do not provide an implicit rate, the Company uses an estimate of its incremental borrowing rate based on the information available at the lease commencement date, being the rate incurred to borrow on a collateralized
BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: basis over a similar term at an amount equal to the lease payments in a similar economic environment.
+Added: The Company has provided the lessor with a refundable security deposit of $ 0.7 million which is included in Other assets.
Germantown, Maryland
6 unchanged sentences
The Company’s right-of-use asset and lease liability are as follows (in thousands):
+Added: September 30,
2024 December 31,
2 unchanged sentences
Lease liability, non-current $ 10,683 $ 11,191
−Removed: Six months ended June 30,
+Added: Nine months ended September 30,
Other information
2 unchanged sentences
Weighted average discount rate 7.5 % 7.5 %
−Removed: Three months ended June 30, Six months ended June 30,
+Added: Three months ended September 30, Nine months ended September 30,
2024 2023 2024 2023
2 unchanged sentences
Total lease cost $ 369 $ 192 $ 1,086 $ 976
−Removed: Future annual minimum lease payments under operating leases as of June 30, 2024, were as follows (in thousands):
+Added: Future annual minimum lease payments under operating leases as of September 30, 2024, were as follows (in thousands):
Remainder of 2024 $ 496
10 unchanged sentences
Related Party Transactions
−Removed: During the three and six months ended June 30, 2024, the Company incurred expenses of $ 0.3 million and $ 0.5 million, respectively (three and six months ended June 30, 2023:
+Added: During the three and nine months ended September 30, 2024, the Company recognized license revenue of $ 15.0 million (three and nine months ended September 30, 2023:
+Added: nil and $ 0.8 million, respectively), from Oxford University Innovation Limited.
+Added: As of September 30, 2024, the Company accrued a contract asset receivable of $ 15.0 million (December 31, 2023:
+Added: nil ) from Oxford University Innovation Limited.
+Added: During the three and nine months ended September 30, 2024, the Company incurred expenses of $ 0.2 million and $ 0.7 million, respectively (three and nine months ended September 30, 2023:
$ 0.2 million and $ 0.6 million, respectively) from Oxford University Innovation Limited which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford.
−Removed: During the three and six months ended June 30, 2024, the Company recognized license revenue of nil (three and six months ended June 30, 2023:
−Removed: $ 0.3 million and $ 0.8 million, respectively), from Oxford University Innovation Limited.
Management ’ s Discussion and Analysis of Financial Condition and Results of Operations.
2 unchanged sentences
Factors that might cause future results to differ materially from those projected in the forward-looking statements include, but are not limited to, those set forth in our Annual Report on Form 10-K and in other filings with the SEC.
−Removed: We are a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases and autoimmunity.
+Added: We are a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide T cells to overcome chronic infectious diseases and autoimmunity.
Helping patients and their families is the guiding principle at the heart of Barinthus Bio.
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and synthetic, consisting of SNAP-Tolerance Immunotherapy, or SNAP-TI.
−Removed: 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.
−Removed: Our immunotherapeutic candidates are designed to work by increasing disease-specific CD8+ T cell activity in the case of chronic infectious diseases, or by dampening CD4+ and CD8+ T cells, and increasing regulatory T cells in autoimmunity.
+Added: These platforms are enabling us to develop antigen-specific immunotherapeutic candidates designed to optimize the disease fighting capabilities of T cells and restore a healthy balance.
+Added: Our immunotherapeutic candidates are designed to work by increasing disease-specific CD8+ T cell activity in the case of chronic infectious diseases, or by dampening effector CD4+ and CD8+ T cells, and increasing regulatory T cells in autoimmunity.
Following our strategic pipeline update in June 2024, we are prioritizing a pipeline of two key product candidates in infectious disease and autoimmunity that harness our proprietary viral vector and synthetic platform technologies.
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VTP-300, a Phase 2 immunotherapeutic candidate designed as a potential component of a functional cure for chronic hepatitis B virus infection utilizing ChAdOx/MVA;
−Removed: and VTP-1000, our first preclinical autoimmune candidate designed to utilize the SNAP-TI platform to treat patients with celiac disease.
−Removed: We have two other programs in infectious disease and cancer:
−Removed: VTP-200, a Phase 2 nonsurgical product candidate for persistent high-risk HPV;
−Removed: and VTP-850, a second-generation Phase 2 immunotherapeutic candidate designed to treat recurrent prostate cancer.
−Removed: Alongside these proprietary programs, we have partnerships in place to advance three additional prophylactic and therapeutic product candidates including VTP-500 for Middle East Respiratory Syndrome, or MERS, VTP-400 for Zoster and VTP-600 for multiple cancer indications including Non-Small Cell Lung Cancer, or NSCLC, and Squamous Esophageal Cancer.
−Removed: We also co-invented a COVID-19 vaccine with the University of Oxford, which was exclusively licensed worldwide to AstraZeneca.
−Removed: 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 chronic infectious diseases and autoimmune-disorders that have a significant impact on their every day lives.
+Added: and VTP-1000, our first clinical autoimmune candidate designed to utilize the SNAP-TI platform to treat patients with celiac disease, and marking our entry into the autoimmunity space.
+Added: We are evaluating VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer through to the end of an ongoing Phase 1 clinical trial.
+Added: Alongside these proprietary programs, we have partnerships in place to advance three additional prophylactic and therapeutic product candidates including VTP-500 for Middle East Respiratory Syndrome, or MERS, VTP-400 for Zoster and VTP-600 for multiple cancer indications including Non-Small Cell Lung Cancer, or NSCLC, and Squamous Esophageal Cancer, or ESCC.
+Added: We also co-invented Vaxzevria, a COVID-19 vaccine with the University of Oxford, which was exclusively licensed worldwide to AstraZeneca.
+Added: We believe our proven scientific expertise, focused portfolio and experience on product candidate development uniquely positions us to navigate towards delivering treatments for patients with chronic infectious diseases and autoimmune-disorders that have a significant impact on their everyday 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 American Depositary Shares, or ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million.
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We also simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, providing for the offering, issuance and sale by us of up to an aggregate of $75.0 million of our ordinary shares represented by ADSs from time to time in “at-the-market” offerings under the Shelf.
−Removed: As of June 30, 2024, we have sold 1,530,515 ordinary shares represented by ADSs under the sales agreement, amounting to net proceeds of $3.8 million.
+Added: As of September 30, 2024, we have sold 1,875,848 ordinary shares represented by ADSs under the sales agreement, amounting to net proceeds of $4.3 million.
We incurred net losses each year since inception through to December 31, 2021.
−Removed: 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.
+Added: For the year ended December 31, 2022, we generated net income of $5.3 million, primarily as a result of revenues arising from prior AstraZeneca sales of Vaxzevria and our agreement with Oxford University Innovation (OUI).
For the year ended December 31, 2023, we generated a net loss of $73.4 million.
−Removed: For the three and six months ended June 30, 2024, we incurred a net loss of $17.0 million and $32.5 million, respectively.
−Removed: As of June 30, 2024, we had an accumulated deficit of $209.0 million and we do not currently expect positive cash flows from operations in the foreseeable future.
−Removed: 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.
+Added: For the three and nine months ended September 30, 2024, we incurred a net loss of $8.1 million and $40.6 million, respectively.
+Added: As of September 30, 2024, we had an accumulated deficit of $217.1 million and we do not currently expect positive cash flows from operations in the foreseeable future.
+Added: We expect to incur net
+Added: 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.
At this time, we cannot reasonably estimate, or know the nature, timing and estimated costs of all of the efforts that will be necessary to complete the development of any of our product candidates that we develop through our programs.
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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.
−Removed: 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: 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
+Added: financings, collaborations, licensing arrangements or other sources, or any combination of the foregoing.
Based on our research and development plans, we expect that our existing cash, cash equivalents and restricted cash and other financial resources, will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2026.
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These are estimated timelines only and our pipeline may be subject to change.
−Removed: In June 2024, we announced updated data from two ongoing clinical trials in people with chronic hepatitis B, or CHB, at the European Association for the Study of the Liver, or EASL, Congress 2024.
−Removed: The presentations included updated interim data from the Phase 2b clinical trial (HBV003), as well as new interim data from the Phase 2a clinical trial (IM-PROVE II, AB-729-202) in partnership with Arbutus Biopharma, both in people with CHB receiving ongoing standard of care nucleos(t)ide analogue, or NUC, therapy.
−Removed: Interim HBV003 data:
−Removed: VTP-300 and Low-dose Nivolumab
−Removed: Interim data from the HBV003 trial showed that nearly 20% of participants across the groups had undetectable HBsAg and this was maintained for ≥16 weeks in the two cases who have reached that timepoint.
−Removed: 76% of participants were eligible for NUC discontinuation and 71% of those who did discontinue remained off NUCs at time of data cutoff on April 15, 2024.
−Removed: 67% of participants across all groups assessed for NUC discontinuation had HBsAg <10 IU/mL at Week 24 or later.
−Removed: Robust T cell responses were observed to all VTP-300 encoded antigens.
−Removed: There were no Serious Adverse Events, or SAEs, Grade 3 or 4 Adverse Events, or AEs, related to treatment.
−Removed: Interim IM-PROVE II data:
−Removed: imdusiran and VTP-300
−Removed: Interim data from the IM-PROVE II clinical trial showed that at week 72, 20% of participants had undetectable HBsAg in the VTP-300 treatment group compared to none in the placebo group.
−Removed: 84% of participants in the VTP-300 treatment group were eligible for NUC discontinuation and 88% of those who did discontinue remained off NUCs, compared to the placebo group showing 52% of participants eligible for NUC discontinuation and 80% remaining off NUCs at time of data cutoff on April 12, 2024.
−Removed: Robust reductions of HBsAg were observed during the imdusiran lead-in period with 95% of participants achieving HBsAg <100 IU/mL before undergoing dosing in the VTP-300 treatment or placebo groups at week 24, with a statistically significant difference (p<0.05) in HBsAg levels between the VTP-300 treatment and placebo groups recorded at week 72.
−Removed: Treatment with imdusiran and VTP-300 was generally well-tolerated, with no SAEs or treatment discontinuations reported.
−Removed: A further data update on both trials showing more participants progressed through more time points, as well as preliminary results from IM-PROVE II, is expected in the fourth quarter of 2024.
−Removed: Impact of Israel and Gaza Conflict and Ukraine Crisis
−Removed: In respect of the international conflict in Israel and Gaza and situation in Ukraine, we have no operations or suppliers based in Israel or Gaza, or 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.
+Added: VTP-300 (Chronic hepatitis B)
+Added: In September 2024, enrollment was completed in the HBV003 trial (NCT05343481) of VTP-300 in 121 adult participants with chronic hepatitis B.
+Added: The Phase 2b trial is designed to obtain critical dosing information for a potential functional cure regimen for chronic hepatitis B, with participants receiving VTP-300 and low-dose (LD) nivolumab.
+Added: A further data update on both the ongoing HBV003 Phase 2b and IM-PROVE Phase 2a trials in collaboration with Arbutus Biopharma is expected at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2024 scheduled from November 15-19, 2024 in San Diego, CA., with a late-breaking oral presentation and late-breaking poster having been accepted on the trials, respectively.
+Added: VTP-1000 (Celiac Disease)
+Added: In September 2024, we initiated the first-in-human Phase 1 trial of VTP-1000 in adults with celiac disease.
+Added: The AVALON trial is a randomized, placebo-controlled clinical trial, which includes a controlled gluten challenge.
+Added: It will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000.
+Added: VTP-850 (Prostate Cancer)
+Added: In October 2024, we announced that the PCA001 trial (NCT05617040) of VTP-850 in men with rising prostate-specific antigen (PSA) after definitive local therapy for prostate cancer (i.e.
+Added: , biochemical recurrence) had completed enrollment of 22 participants.
+Added: The Phase 1 trial is designed to evaluate safety and efficacy, as measured by PSA and T cell response.
+Added: We expect to have data from this Phase 1 trial in the first half of 2025.
+Added: Management Team
+Added: Effective from September 1, 2024, Graham Griffiths, our Chief Business Officer since October 2017, was promoted to Chief Operating Officer.
+Added: Financial Update
+Added: In October 2024, we were informed of additional amounts due to the Company from Oxford University Innovation (OUI) in relation to the Company's share of royalties received by OUI as a result of prior commercial sales of Vaxzevria® by AstraZeneca.
+Added: As a result, $15.0 million revenue has been recognized in the third quarter of 2024.
+Added: There is no expectation of additional payments or that we will be notified of such payments in a timely manner.
+Added: We expect that this additional revenue will enable us to fund our research and development plans further into the second quarter of 2026.
+Added: Impact of Israel and Gaza Conflict, Ukraine Crisis and Iran Conflict
+Added: In respect of the international conflict in Israel and Gaza, situation in Ukraine and Iran conflict, we have no operations or suppliers based in Israel or Gaza, or in Ukraine, Belarus, Russia or Iran, and as a result, as of the date of this 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
9 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 commercial sales of Vaxzevria.
−Removed: Our revenue for the three and six months ended June 30, 2024 was nil (three and six months ended June 30, 2023:
−Removed: $0.3 million and $0.8 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: In May 2024, AstraZeneca announced its planned withdrawal of Vaxzevria as demand had declined, and therefore we do not expect to receive any future revenue relating to commercial sales of Vaxzevria.
+Added: In March 2022, we were notified by OUI of the commencement of revenue relating to prior commercial sales of Vaxzevria.
+Added: Our revenue for the three and nine months ended September 30, 2024 was $15.0 million (three and nine months ended September 30, 2023:
+Added: nil and $0.8 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.
+Added: In May 2024, AstraZeneca announced its planned withdrawal of Vaxzevria as demand had declined, and therefore we do not expect to receive any future revenue relating to future 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,
−Removed: conducting preclinical studies, developing various manufacturing processes, initiating the clinical trials for VTP-200, VTP-300, VTP-600 and VTP-850 and readying VTP-500, and VTP-1000 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, conducting preclinical studies, developing various manufacturing processes, initiating the clinical trials for VTP-200,
+Added: VTP-300, VTP-600, VTP-850 and VTP-1000 and readying VTP-500 for clinical trials.
Research and development activities account for a large portion of our operating expenses, and we expect research and development expenses to increase in the future.
13 unchanged sentences
Other Operating Income
−Removed: 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.
−Removed: 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: Other operating income includes 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 income on a systematic basis over the periods in which we recognize expenses for the related costs for which the grants are intended to compensate.
Payments received in advance of incurring reimbursable expenses are recorded as deferred income.
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Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects.
−Removed: Certain subcontracted qualifying research and development expenditures are eligible for a cash rebate of up to 21.7%.
+Added: Certain subcontracted qualifying research and development expenditures were eligible for a cash rebate of up to 21.7%.
A large portion of costs relating to research and development, clinical trials and manufacturing activities are eligible for inclusion within these tax credit cash rebate claims.
From April 2023, under the SME Program, the 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 33.4% to 18.6% (or 27.0% for R&D intensive SMEs) and from 21.7% to 12.1% for subcontractors.
−Removed: 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 previous SME Program.
+Added: We are regularly assessing if we can claim under the loss-making R&D Intensive Scheme for SMEs, which would provide benefits consistent with those claimed under the previous SME Program.
+Added: From the analysis performed, we do not currently expect to claim under the loss-making R&D Intensive Scheme for SMEs primarily due to the proportion of total relevant expenditure occurring outside the United Kingdom.
We may not be able to continue to claim research and development tax credits under the SME program in the future because we may no longer qualify as a small or medium-sized company.
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If such an exception does not apply, this could restrict the amount of payable credit that we claim.
+Added: The merged scheme Research & Development expenditure credit (RDEC) and enhanced R&D intensive support (ERIS) replace the old RDEC and small and medium-sized enterprise (SME) schemes for accounting periods beginning on or after April 1, 2024.
+Added: For expenditure under the merged scheme, the rate of Research and Development expenditure credit will be 20%, which is the same as the rate under the old RDEC scheme for expenditure incurred on or after April 1, 2023.
+Added: For loss-makers and small profit-makers, a lower rate of notional tax restriction (currently 19%) applies at payment.
+Added: For all other companies, the restriction will continue to apply at the Corporation Tax main rate (currently 25%).
+Added: The amount of the PAYE cap for claims under both the merged scheme and ERIS is £20,000 plus 300% of the company’s relevant PAYE and National Insurance contributions liabilities.
+Added: The PAYE cap (where applicable) will limit the amount of payable credit that can be received in the accounting period under consideration.
+Added: Any excess over the cap will be carried forward and treated as an amount of Research and Development expenditure credit to which the company will be entitled for the next accounting period.
+Added: Based on prior claims and the split of qualifying spend it is expected that the PAYE cap is unlikely to affect the net benefit and the EU State Aid cap will not impact the benefit under the merged scheme.
+Added: Furthermore, for accounting periods starting on or after April 1, 2024, legislation included in Finance Act 2024 restricts the extent to which payments to contractors for R&D, and externally provided workers can qualify for R&D relief where R&D activity takes place outside the UK.
+Added: This may restrict the ability to include cost incurred on EPWs based in the US and Switzerland for future accounting periods.
Unsurrendered UK losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions.
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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 recognized as of June 30, 2024 related to the acquisition of Avidea on December 10, 2021.
−Removed: The Company identified qualitative indicators of impairment due to a sustained decline in the price of the Company’s ADSs, whereby the market capitalization continues to be below the value of the net assets of the Company, and the plans announced in June 2024 to prioritize its pipeline to focus on the development of VTP-300 for chronic Hepatitis B virus infection and VTP-1000 in celiac disease.
−Removed: Therefore, the Company performed both an interim qualitative and quantitative assessment as of June 30, 2024 to determine whether it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
−Removed: Based on this assessment, management determined it is not more likely than not that the fair value of the reporting unit is less than its carrying amount and hence no impairment loss related to goodwill has been recognized related to goodwill for the three and six months ended June 30, 2024.
+Added: The goodwill of $12.2 million recognized as of September 30, 2024 relates to the acquisition of Avidea on December 10, 2021.
+Added: The Company has identified qualitative indicators of impairment due to a sustained decline in the price of the Company’s ADSs, whereby the market capitalization continues to be below the value of the net assets of the Company, and the plans announced in June 2024 to prioritize its pipeline to focus on the development of VTP-300 for chronic Hepatitis B virus infection and VTP-1000 in celiac disease.
+Added: Therefore, the Company performed both an interim qualitative and quantitative assessment in July 2024 to determine whether it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
+Added: The Company also performed an interim qualitative assessment as of September 30, 2024 and did not identify any additional circumstances that may indicate it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
+Added: Based on these assessments, 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 related to goodwill for the three and nine months ended September 30, 2024.
Long-lived assets
4 unchanged sentences
Given this change in Company focus, management identified circumstances that could indicate that the carrying amount of the Company's intangible assets may not be recoverable.
−Removed: Therefore, the Company performed both a qualitative and quantitative assessment as of June 30, 2024 and determined that the carrying amount of the Company's intangible assets are recoverable, hence no impairment loss related to intangible assets has been recorded during the three and six months ended June 30, 2024.
+Added: Therefore, the Company performed both a qualitative and quantitative assessment in July 2024 and determined that the carrying amount of the Company's intangible assets are recoverable.
+Added: As of September 30, 2024, the Company did not identify any additional circumstances that may indicate the carrying amount of the Company's intangible assets are not recoverable, hence no impairment loss related to intangible assets has been recorded during the three and nine months ended September 30, 2024.
Contingent consideration
We recognize a contingent consideration liability related to the acquisition of Avidea.
−Removed: The liability is remeasured to fair value at each reporting date until the contingency is resolved.
−Removed: 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.
−Removed: Changes in fair value are recognized in general and administrative expenses in the condensed consolidated statement of operations and comprehensive loss.
Avidea’s stockholders may be entitled to receive an aggregate of up to $40.0 million in additional payments, payable in a combination of cash and ADSs, upon the achievement of certain milestones.
This contingent consideration is included within the purchase price and is recognized at its fair value on the acquisition date, and subsequently remeasured to fair value at each reporting date until the contingency is resolved.
−Removed: Changes in fair value are recognized in 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.
+Added: The fair value of the contingent consideration is a Level 3 valuation determined using significant unobservable inputs, being the probability of pursuit of the activity associated with the milestone, the probability of success of the achievement of the milestone, the expected date of milestone achievement and applying the relevant discount rate.
+Added: Changes in fair value are recognized in general and administrative expenses in the condensed consolidated statements of operations and comprehensive income.
Results of Operations
−Removed: Comparison of the Three Months Ended June 30, 2024 and 2023
+Added: Comparison of the Three Months Ended September 30, 2024 and 2023
The following table sets forth the significant components of our results of operations (in thousands):
−Removed: Three months ended June 30, 2024 Three months ended June 30, 2023 Change
+Added: Three months ended September 30, 2024 Three months ended September 30, 2023 Change
License revenue
2 unchanged sentences
Research and development 11,139 15,144 (4,005)
−Removed: 11,662 13,543 (1,881)
General and administrative 13,420 961 12,459
7 unchanged sentences
Research and development incentives 608 1,205 (597)
+Added: Other income/(expense)
Total other income 1,248 1,392 (144)
3 unchanged sentences
$ (8,129) $ (14,110) $ 5,981
−Removed: 1 Includes license revenue from related parties for the three months ended June 30, 2024 of nil and for the three months ended June 30, 2023 of $0.3 million.
+Added: For the three months ended September 30, 2024, and 2023, our revenue consisted of $15.0 million and nil, respectively, from the OUI License Agreement Amendment with respect to payments due from OUI in connection with prior commercial sales of Vaxzevria.
+Added: There is no guarantee that such payments will be made in the future and, if they do, that we will be notified of such payments in a timely manner.
Research and Development Expenses
−Removed: The following table summarizes our research and development expenses for the three months ended June 30, 2024 and 2023 (in thousands):
−Removed: Three Months Ended June 30, 2024 Three Months Ended June 30, 2023 Change
+Added: The following table summarizes our research and development expenses for the three months ended September 30, 2024 and 2023 (in thousands):
+Added: Three Months Ended September 30, 2024 Three Months Ended September 30, 2023 Change
Direct research and development expenses by program:
2 unchanged sentences
VTP-500 MERS 1
−Removed: VTP-600 NSCLC 2
+Added: VTP-600 NSCLC/ESCC 2
VTP-850 Prostate cancer 914 1,724 (810)
5 unchanged sentences
Personnel-related (including share-based compensation) 4
+Added: 3,871 2,711 1,160
Facility related 214 368 (154)
3 unchanged sentences
1 The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).
−Removed: 2 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK.
+Added: 2 The VTP-600 NSCLC/ESCC Phase 1/2a trial is sponsored by Cancer Research UK.
3 Research and development expenses related to VTP-1100 HPV Cancer were presented together with VTP-1000 Celiac in the prior period comparative, because our SNAP product candidates were both preclinical.
Expenses related to VTP-1100 HPV Cancer are now included in "Other and earlier stage programs," because we are deferring the planned IND application for VTP-1100 in HPV cancer and we are preparing to initiate the clinical trial for VTP-1000 Celiac.
−Removed: Our research and development expenses for the three months ended June 30, 2024 and 2023 were $11.7 million and $13.5 million, respectively.
−Removed: Direct expenses for the three months ended June 30, 2024 and 2023 were $6.4 million and $9.6 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 $3.2 million decrease, $1.5 million pertains to a reduction in clinical trial and manufacturing development costs for the VTP-200 HPV program following the completion of the Phase 1b/2 APOLLO (HPV001) clinical trial in the first quarter of 2024 and $1.6 million pertains to the reduction in pre-clinical studies related to the SNAP platform following the IND acceptance for VTP-1000 in celiac disease, and the deprioritization of VTP-1100 for HPV cancer announced earlier in 2024.
−Removed: Indirect research and development expenses for the three months ended June 30, 2024 and 2023 were $5.2 million and $3.9 million, respectively.
−Removed: The increase of $1.3 million relates primarily to an increase in headcount and the provision for severance costs primarily in the United Kingdom following the Company’s announcement in June 2024 to prioritize its pipeline and reduce the size of the workforce.
+Added: 4 This includes $0.6 million of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program funded by CEPI.
+Added: Our research and development expenses for the three months ended September 30, 2024 and 2023 were $11.1 million and $15.1 million, respectively.
+Added: Direct expenses for the three months ended September 30, 2024 and 2023 were $6.5 million and $11.6 million, respectively, and consisted of outside services, consultants, laboratory materials, clinical trials, manufacturing of clinical trial materials, as well as costs for external preclinical services and sample testing.
+Added: Of the $5.1 million decrease, $2.1 million pertains to a decrease in VTP-300 HBV clinical trial and manufacturing costs as enrollment for the two ongoing Phase 2 trials is now complete, $0.8 million pertains to the completion of the VTP-1000 clinical trial in the third quarter of 2024, and $1.0 million pertains to a reduction in clinical trial and manufacturing development costs for the VTP-200 HPV program following the completion of the Phase 1b/2 APOLLO (HPV001) clinical trial in the first quarter of 2024.
+Added: Indirect research and development expenses for the three months ended September 30, 2024 and 2023 were $4.6 million and $3.5 million, respectively.
+Added: The increase of $1.1 million primarily relates to personnel expenses, including share-based payment charges of $0.4 million, due to an increase in personnel time spent on research and development activities.
General and Administrative Expenses
−Removed: General and administrative expenses for the three months ended June 30, 2024 and 2023 were $7.2 million and $13.1 million, respectively.
−Removed: The decrease of $5.9 million relates primarily to a decrease of $4.1 million in the net loss on foreign exchange, a $0.6 million decrease in professional costs due to a reduction in activity compared to the prior period, a decrease in insurance costs of $0.6 million due to a reduction in insurance premiums and a decrease in personnel expenses, including share-based payment charges of $0.2 million, primarily due to a reduction in non-cash share-based payment charges.
+Added: General and administrative expenses for the three months ended September 30, 2024 and 2023 were $13.4 million and $1.0 million, respectively.
+Added: The increase of $12.4 million relates primarily to a net increase of $14.3 million in net loss on foreign exchange, offset by a decrease in personnel expenses, including share-based payment charges of $1.3 million, primarily due to a decrease in personnel costs following the reduction in workforce in Q2 2024 and less personnel time spent on general and administrative activities.
Other Operating Income
−Removed: For the three months ended June 30, 2024 and 2023, other operating income was $0.6 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 for the development of VTP-500 through Phase 2 clinical trials for the prevention of MERS.
+Added: For the three months ended September 30, 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 for the development of VTP-500 through Phase 2 clinical trials for the prevention of MERS.
Interest Income
−Removed: For the three months ended June 30, 2024 and 2023, interest income was $0.6 million and $0.5 million, respectively, resulting from the interest earned on our short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.
+Added: For the three months ended September 30, 2024 and 2023, interest income was $0.6 million and $0.2 million, respectively, resulting from the interest earned on our short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.
Research and Development Incentives
−Removed: For the three months ended June 30, 2024 and 2023 research and development incentives were $0.7 million and $0.6 million, respectively.
+Added: For the three months ended September 30, 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 three months ended June 30, 2024 and 2023, the tax benefit was $0.01 million and $1.1 million respectively, which primarily relates to movements in deferred tax.
−Removed: Comparison of the six months ended June 30, 2024 and 2023
+Added: The decrease of $0.6 million is due to reduced expenses eligible for the research and development corporation tax relief, as well as a decrease in the enhanced rate of deduction and credit rate under the scheme, effective from April 2023.
+Added: For the three months ended September 30, 2024 and 2023, the tax benefit was $0.003 million and $0.6 million respectively, which primarily relates to movements in deferred tax.
+Added: Comparison of the Nine months ended September 30, 2024 and 2023
The following table sets forth the significant components of our results of operations (in thousands):
−Removed: Six months ended June 30, 2024 Six months ended June 30, 2023 Change
+Added: Nine months ended September 30, 2024 Nine months ended September 30, 2023 Change
License Revenue
2 unchanged sentences
Research and development 33,926 38,501 (4,575)
−Removed: 22,787 23,357 (570)
General and administrative 26,615 26,227 388
13 unchanged sentences
$ (40,592) $ (56,157) $ 15,565
−Removed: 1 Includes license revenue from related parties for the six months ended June 30, 2024 of nil and for the six months ended June 30, 2023 of $0.8 million.
+Added: For the nine months ended September 30, 2024 and 2023, our revenue consisted of $15.0 million and $0.8 million, respectively, from the OUI License Agreement Amendment with respect to payments due from OUI in connection with
+Added: prior commercial sales of Vaxzevria.
+Added: There is no guarantee that such payments will be made in the future and, if they do, that we will be notified of such payments in a timely manner.
Research and Development Expenses
−Removed: The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023 (in thousands):
−Removed: Six months ended June 30, 2024 Six months ended June 30, 2023 Change
+Added: The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023 (in thousands):
+Added: Nine months ended September 30, 2024 Nine months ended September 30, 2023 Change
Direct research and development expenses by program:
2 unchanged sentences
VTP-500 MERS 1
−Removed: VTP-600 NSCLC 2
+Added: VTP-600 NSCLC/ESCC 2
296 509 (213)
6 unchanged sentences
Personnel-related (including share-based compensation) 4
+Added: 12,968 9,700 3,268
Facility related 947 941 6
3 unchanged sentences
1 The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).
−Removed: 2 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK.
+Added: 2 The VTP-600 NSCLC/ESCC Phase 1/2a trial is sponsored by Cancer Research UK.
3 Research and development expenses related to VTP-1100 HPV Cancer were presented together with VTP-1000 Celiac in the prior period comparative, because our SNAP product candidates were both preclinical.
Expenses related to VTP-1100 HPV Cancer are now included in "Other and earlier stage programs," because we are deferring the planned IND application for VTP-1100 in HPV cancer and we are preparing to initiate the clinical trial for VTP-1000 Celiac.
−Removed: Our research and development expenses for the six months ended June 30, 2024 and 2023 were $22.8 million and $23.4 million, respectively.
−Removed: Direct expenses for the six months ended June 30, 2024 and 2023 were $12.3 million and $15.4 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 $3.2 million decrease, $1.5 million pertains to a reduction in clinical trial and manufacturing development costs for the VTP-200 HPV program following the completion of the Phase 1b/2 APOLLO (HPV001) clinical trial in 2024 and $1.8 million pertains to the reduction in pre-clinical studies related to the SNAP platform following the IND acceptance for VTP-1000 in celiac disease, and the deprioritization of VTP-1100 for HPV cancer announced earlier in 2024.
−Removed: Indirect research and development expenses for the six months ended June 30, 2024 and 2023 were $10.5 million and $7.9 million, respectively.
−Removed: Of the $2.6 million increase, $2.1 million relates to an increase in headcount and the provision for severance costs across our locations in the United Kingdom and United States following the Company’s announcement in June 2024 to prioritize its pipeline and reduce the size of the workforce.
+Added: 4 This includes $0.6 million of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program funded by CEPI.
+Added: Our research and development expenses for the nine months ended September 30, 2024 and 2023 were $33.9 million and $38.5 million, respectively.
+Added: Direct expenses for the nine months ended September 30, 2024 and 2023 were $18.8 million and $27.1 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 $8.3 million decrease, $3.1 million pertains to a decrease in VTP-300 HBV clinical trial and manufacturing costs as enrollment for the two ongoing Phase 2 trials is now complete, $2.6 million pertains to the completion of the VTP-1000 clinical trial in the third quarter of 2024, and the deprioritization of VTP-1100 for HPV cancer announced earlier in 2024, and $2.6 million pertains to a reduction in clinical trial and manufacturing development costs for the VTP-200 HPV program following the completion of the Phase 1b/2 APOLLO (HPV001) clinical trial in 2024.
+Added: Indirect research and development expenses for the nine months ended September 30, 2024 and 2023 were $15.1 million and $11.4 million, respectively.
+Added: Of the $3.7 million increase, $3.3 million relates primarily to an average increase in headcount on a year-to-date basis, severance costs of $0.7 million across our locations in the United Kingdom and United States following the Company’s announcement in June 2024 to prioritize its pipeline, more personnel time spent on research and development activities a nd higher share-based payment charges due to higher value awards expensed in the period.
General and Administrative Expenses
−Removed: General and administrative expenses for the six months ended June 30, 2024 and 2023 were $13.2 million and $25.3 million, respectively.
−Removed: The decrease of $12.1 million relates primarily to a gain of $1.1 million on foreign exchange for the six months ended June 30, 2024, compared to a loss of $7.7 million for the six months ended June 30, 2023, a decrease in personnel expenses, including share-based payment charges of $1.1 million, primarily due to a reduction in non-cash share-based payment charges, a decrease in insurance costs of $1.4 million due to a reduction in insurance premiums, a decrease of $0.4 million in professional costs due to reduced activity compared to the prior period and a decrease of $0.3 million in facility related costs due to the relocation to our new U.S.
+Added: General and administrative expenses for the nine months ended September 30, 2024 and 2023 were $26.6 million and $26.2 million, respectively.
+Added: The increase of $0.4 million relates primarily to an increase in net loss on foreign exchange of $5.5 million, offset by a decrease in personnel expenses primarily due to a decrease in personnel cost due to the workforce reduction in Q2 2024 (net of $0.1 million severance cost) and a reduction in share-based payment charges due to the timing of high value awards, a decrease in insurance costs of $1.5 million related to a reduction in insurance premiums, and a decrease of $0.7 million in facility related costs due to the relocation to our new U.S.
laboratory in June 2023.
Other Operating Income
−Removed: For the six months ended June 30, 2024 and 2023, other operating income was $0.8 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 for the development of VTP-500 through Phase 2 clinical trials for the prevention of MERS.
+Added: For the nine months ended September 30, 2024 and 2023, other operating income was $1.0 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 for the development of VTP-500 through Phase 2 clinical trials for the prevention of MERS.
Interest Income
−Removed: For the six months ended June 30, 2024 and 2023, interest income was $1.4 million and $2.1 million, respectively, resulting from the interest earned on our short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.
+Added: For the nine months ended September 30, 2024 and 2023, interest income was $2.0 million and $2.3 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 six months ended June 30, 2024 and 2023 research and development incentives were $1.3 million and $1.7 million, respectively.
+Added: For the nine months ended September 30, 2024 and 2023 research and development incentives were $1.9 million and $2.9 million, respectively.
Such research and development incentives relate to corporation tax relief on research and development projects incentive programs in the United Kingdom.
The decrease of $1.0 million is due to reduced expenses eligible for the research and development corporation tax relief, as well as a decrease in the enhanced rate of deduction and credit rate under the scheme, effective from April 2023.
−Removed: 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 previous SME Program.
−Removed: For the six months ended June 30, 2024 and 2023, the tax benefit was $0.04 million and $1.7 million respectively, which primarily relates to movements in deferred tax.
+Added: For the nine months ended September 30, 2024 and 2023, the tax benefit was $0.05 million and $2.3 million respectively, which primarily relates to movements in deferred tax.
Liquidity and Capital Resources
1 unchanged sentence
Since our inception, we have funded our operations primarily through private and public placements of our ordinary and preferred shares as well as from grants and research incentives, various agreements with public funding agencies, the issuance of convertible loan notes, and most recently from upfront, royalty and milestone payments from OUI in connection with the OUI License Agreement Amendment.
−Removed: Through June 30, 2024, we received gross proceeds of approximately $328.8 million from the issuance of our ordinary and preferred shares and convertible loan notes.
−Removed: As of June 30, 2024, we had cash, cash equivalents and restricted cash of $117.8 million.
+Added: Through September 30, 2024, we received gross proceeds of approximately $329.2 million from the issuance of our ordinary and preferred shares and convertible loan notes.
+Added: As of September 30, 2024, we had cash, cash equivalents and restricted cash of $106.1 million.
Recent financing and corporate milestones include the following:
3 unchanged sentences
• Between April 2022 and June 2023, we received $44.5 million of cash from OUI for the commercial sales of Vaxzevria;
−Removed: • Between December 2022 and June 2024, we raised net proceeds of $3.8 million from the issuance of shares represented by ADSs through “at-the-market” offerings under the sales agreement with Jefferies LLC.
+Added: • Between December 2022 and September 2024, we raised net proceeds of $4.3 million from the issuance of shares represented by ADSs through “at-the-market” offerings under the sales agreement with Jefferies LLC.
On August 9, 2022, we filed the Shelf, with the Securities and Exchange Commission in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million.
1 unchanged sentence
We also simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, providing for the offering, issuance and sale by us of up to an aggregate of $75.0 million of our ordinary shares represented by ADSs from time to time in “at-the-market” offerings under the Shelf.
−Removed: As of June 30, 2024, we have sold 1,530,515 ordinary shares represented by ADSs under the sales agreement amounting to net proceeds of $3.8 million.
+Added: As of September 30, 2024, we have sold 1,875,848 ordinary shares represented by ADSs under the sales agreement amounting to net proceeds of $4.3 million.
We do not currently expect positive cash flows from operations in the foreseeable future, if at all.
3 unchanged sentences
The following table sets forth a summary of the primary sources and uses of cash (in thousands) for each period presented:
−Removed: Six months ended June 30, 2024 Six months ended June 30, 2023
+Added: Nine months ended September 30, 2024 Nine months ended September 30, 2023
Net cash used in operating activities $ (42,026) $ (31,322)
4 unchanged sentences
Cash Used in Operating Activities
−Removed: During the six months ended June 30, 2024, net cash used in operating activities was $23.8 million, primarily resulting from our net loss of $32.5 million adjusted by share based compensation of $2.8 million, depreciation and amortization of $2.9 million, non-cash lease expenses of $0.7 million, unrealized foreign exchange gain of $0.6 million and changes in our operating assets and liabilities, net, of $2.7 million primarily related to a $2.1 million increase in accounts payable and accrued expenses, a $0.8 million increase in deferred revenue, and a $0.8 million decrease in operating lease liabilities.
−Removed: During the six months ended June 30, 2023, net cash used in operating activities was $20.1 million, primarily resulting from our net loss of $42.0 million adjusted by share based compensation of $4.2 million, depreciation and amortization of $2.5 million, non-cash lease expense of $0.6 million, foreign exchange gain of $7.1 million, contingent consideration adjustment of $0.3 million, deferred tax benefit of $1.7 million and changes in our operating assets and liabilities, net of $8.9 million primarily related to the receipt of lease incentives for Barinthus NA and OUI receivable.
+Added: During the nine months ended September 30, 2024, net cash used in operating activities was $42.0 million, primarily resulting from our net loss of $40.6 million adjusted by unrealized foreign exchange loss of $2.0 million, depreciation and amortization of $4.4 million, share based compensation of $4.0 million, non-cash lease expenses of $1.1 million, and changes in our operating assets and liabilities, net of $12.6 million primarily related to a $15.0 million increase in contract asset (including related parties), a $2.1 million decrease in prepaid expenses, a $2.0 million increase in deferred income, a $1.3 million decrease in operating lease liabilities and a $0.2 million decrease in accounts payable and accrued expenses.
+Added: During the nine months ended September 30, 2023, net cash used in operating activities was $31.3 million, primarily resulting from our net loss of $56.2 million adjusted by share based compensation of $4.3 million, depreciation and amortization of $4.0 million, non-cash lease expense 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 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.
Net Cash Used in Investing Activities
−Removed: During the six months ended June 30, 2024 and 2023, cash used in investing activities was $0.5 million and $5.5 million, respectively.
−Removed: These amounts resulted primarily from capital expenditures related to leasehold improvements on our new office and laboratory facilities in Germantown, Maryland, United States, that we relocated to in June 2023.
+Added: During the nine months ended September 30, 2024, and 2023 cash used in investing activities was $0.6 million and $5.6 million, respectively.
+Added: These amounts are resulted primarily from capital expenditures related to leasehold improvements on our new office and laboratory facilities in Germantown, Maryland, United States, that we relocated to in June 2023.
Net Cash Provided by Financing Activities
−Removed: During the six months ended June 30, 2024 and 2023, cash provided by financing activities was $0.9 million and $1.7 million, respectively.
+Added: During the nine months ended September 30, 2024 and 2023, cash provided by financing activities was $1.3 million and $1.8 million, respectively.
These amounts primarily related to net proceeds received from the issuance of ordinary shares through the “at-the-market” sales agreement.
Effect of exchange rates on cash, cash equivalents and restricted cash
−Removed: During the six months ended June 30, 2024 and 2023, the effect of foreign exchange on cash, cash equivalents and restricted cash was a loss of $0.8 million and a gain of $2.6 million respectively, primarily as a result of fluctuations between the United States dollar and pound sterling exchange rates.
+Added: During the nine months ended September 30, 2024 and 2023, the effect of foreign exchange on cash, cash equivalents and restricted cash was a gain of $5.3 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
−Removed: 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 June 30, 2024.
−Removed: As of June 30, 2024, we had an accumulated deficit of $209.0 million.
+Added: As a result, we have 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 September 30, 2024 and year ended December 31, 2023.
+Added: As of September 30, 2024, we had an accumulated deficit of $217.1 million.
We expect to continue to incur significant losses and negative cash flows from operations for the foreseeable future.
18 unchanged sentences
We believe that we will continue to expend substantial resources for the foreseeable future in connection with the development of our current product candidates and programs as well as any future product candidates we may elect to pursue, as well as the gradual gaining of control over our required manufacturing capabilities and other corporate functions.
−Removed: These expenditures will include costs associated with conducting preclinical studies and clinical trials, obtaining regulatory approvals, and potentially in-house manufacturing and supply, as well as marketing and selling any products approved for sale.
+Added: These expenditures will include costs associated with conducting preclinical studies and clinical trials, obtaining regulatory approvals, and potentially in-house manufacturing and supply, as well as marketing and
+Added: selling any products approved for sale.
In addition, other unanticipated costs may arise as outlined above.
10 unchanged sentences
• the timing, receipt and amount of sales of, or royalties or other income from, our future products, if any;
−Removed: • the emergence and success or otherwise of competing oncology and infectious disease therapies and other market developments.
+Added: • the emergence and success or otherwise of competing infectious disease or autoimmune therapies and other market developments.
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.
12 unchanged sentences
We have contingent payment obligations that we may incur upon achievement of clinical, regulatory and commercial milestones, as applicable, or royalty payments that we may be required to make under our licenses;
−Removed: however, the amount, timing and likelihood of such payments are not known as of June 30, 2024.
+Added: however, the amount, timing and likelihood of such payments are not known as of September 30, 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.