4 unchanged sentences
Condensed Consolidated Statements of Operations and Comprehensive Loss
−Removed: Condensed Consolidated Statements of Changes in S tock holders’ Equity
+Added: Condensed Consolidated Statements of Changes in Stockholders’ Equity
Condensed Consolidated Statements of Cash Flows
45 unchanged sentences
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
−Removed: Three months ended
−Removed: March 31, 2024 March 31, 2023
+Added: Three months ended Six months ended
+Added: June 30, 2024 June 30, 2023 June 30, 2024 June 30, 2023
License revenue 1
+Added: $ — $ 334 $ — $ 802
Total revenue — 334 — 802
9 unchanged sentences
Research and development incentives 693 559 1,287 1,716
+Added: Other income 20 310 20 310
Total other income, net 1,336 1,377 2,693 4,122
9 unchanged sentences
Net loss $ ( 16,943 ) $ ( 23,824 ) $ ( 32,463 ) $ ( 42,047 )
−Removed: Other comprehensive (loss)/gain – foreign currency translation adjustments ( 1,577 ) 4,580
+Added: Other comprehensive gain/(loss) – foreign currency translation adjustments 164 5,604 ( 1,413 ) 10,184
Comprehensive loss ( 16,779 ) ( 18,220 ) ( 33,876 ) ( 31,863 )
1 unchanged sentence
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 months ended March 31, 2024 and 2023 of nil and $ 0.5 million, respectively.
+Added: 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.
The accompanying notes are an integral part of these condensed consolidated financial statements.
3 unchanged sentences
(IN THOUSANDS, EXCEPT NUMBER OF SHARES)
−Removed: Three months ended March 31, 2024
+Added: Three and Six months ended June 30, 2024
Ordinary Shares Deferred A Shares
6 unchanged sentences
Balance, March 31, 2024 38,952,956 $ 1 63,443 $ 86 $ 388,720 $ ( 192,079 ) $ ( 24,895 ) $ 171,833 $ 183 $ 172,016
−Removed: Three months ended March 31, 2023
+Added: Share based compensation — — — — 1,195 — — 1,195 — 1,195
+Added: Issue of ordinary shares, net of issuance costs 231,382 0 1 — — 358 — — 358 — 358
+Added: Foreign currency translation adjustments — — — — — — 163 163 1 164
+Added: Net loss — — — — — ( 16,931 ) — ( 16,931 ) ( 12 ) ( 16,943 )
+Added: Balance, June 30, 2024 39,184,338 $ 1 63,443 $ 86 390,273 $ ( 209,010 ) $ ( 24,732 ) $ 156,618 $ 172 $ 156,790
+Added: Three and Six months ended June 30, 2023
Ordinary Shares Deferred A Shares Deferred B Shares Deferred C Shares
7 unchanged sentences
Balance, March 31, 2023 38,357,025 $ 1 63,443 $ 86 — $ — — $ — $ 383,523 $ ( 121,423 ) $ ( 28,886 ) $ 233,301 $ 268 $ 233,569
+Added: Share based compensation — — — — — — — — 1,990 — — 1,990 — 1,990
+Added: Issue of ordinary shares, net of issuance costs 167,034 0 1 — — — — — — 123 — — 123 — 123
+Added: Foreign currency translation adjustments — — — — — — — — — — 5,597 5,597 7 5,604
+Added: Net loss — — — — — — — — — ( 23,802 ) — ( 23,802 ) ( 22 ) ( 23,824 )
+Added: Balance, June 30, 2023 38,524,059 $ 1 63,443 $ 86 — $ — — $ — $ 385,636 $ ( 145,225 ) $ ( 23,289 ) $ 217,209 $ 253 $ 217,462
1 Indicates amount less than one thousand
3 unchanged sentences
(IN THOUSANDS)
−Removed: Three months ended
−Removed: March 31, 2024 March 31, 2023
+Added: Six months ended
+Added: June 30, 2024 June 30, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:
31 unchanged sentences
Supplemental cash flow disclosures:
−Removed: Cash paid for interest $ — $ 0 1
−Removed: Cash paid for income taxes $ — $ 0 1
Non-cash investing and financing activities:
−Removed: Issue of ordinary shares $ — $ 0 1
Purchases of property and equipment included in accounts payable and accrued liabilities $ — $ 506
7 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”.
−Removed: The Company is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer.
+Added: 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.
The Company is headquartered in Harwell, Oxfordshire, United Kingdom.
The Company operates in an environment of rapid technological change and substantial competition from pharmaceutical and biotechnology companies.
−Removed: The Company is subject to risks common to companies in the biopharmaceutical industry in a similar stage of its life cycle including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its vaccine product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of any of its products that are approved, and protection of proprietary technology.
+Added: The Company is subject to risks common to companies in the biopharmaceutical industry in a similar stage of its life cycle including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its immunotherapeutic product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of any of its products that are approved, and protection of proprietary technology.
There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain required regulatory approval or that any approved products will be commercially viable.
9 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 March 31, 2024, the Company had cash, cash equivalents and restricted cash of $ 130.0 million and an accumulated deficit of $ 192.1 million, and the Company expects to incur losses for the foreseeable future.
+Added: 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.
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.
7 unchanged sentences
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Unaudited Condensed Financial Information
−Removed: The accompanying Condensed Consolidated Balance Sheets as of March 31, 2024, and December 31, 2023, the Condensed Consolidated Statements of Operations and Comprehensive Loss, Condensed Consolidated Statements of Changes in Stockholders’ Equity and the Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2024 and 2023 are unaudited.
+Added: Unaudited Condensed Consolidated Financial Information
+Added: 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.
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 March 31, 2024, our results of operations for the three months ended March 31, 2024, and 2023, and our cash flows for the three months ended March 31, 2024, and 2023.
−Removed: The results of operations for the three months ended March 31, 2024, are not necessarily indicative of the results to be expected for the year ending December 31, 2024, or any other interim periods.
+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 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.
+Added: 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.
Summary of Significant Accounting Policies
1 unchanged sentence
Use of Estimates
−Removed: The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue, income and expenses during the reporting period.
−Removed: The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances.
+Added: The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting period.
+Added: The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances.
The Company evaluates its estimates and assumptions on an ongoing basis.
The Company’s actual results may differ from these estimates under different assumptions or conditions.
−Removed: As of the date of issuance of these unaudited condensed consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities.
+Added: As of the date of issuance of these unaudited condensed consolidated financial statements, the Company is not aware of any other specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities.
These estimates may change as new events occur and additional information is obtained and are recognized in the unaudited condensed consolidated financial statements as soon as they become known.
4 unchanged sentences
The Company views its operations and manages its business as one operating segment, the research and development of vaccines and immunotherapies.
+Added: The chief operating decision maker uses net loss 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 months ended March 31, 2024, was a gain of $ 1.2 million (three months ended March 31, 2023:
−Removed: $ 3.5 million loss).
+Added: 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:
+Added: $ 4.2 million loss and $ 7.7 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 months ended March 31, 2024, and 2023 (in thousands, except number of shares):
−Removed: Three months ended March 31,
+Added: 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):
+Added: Three months ended June 30, Six months ended June 30,
+Added: 2024 2023 2024 2023
Net loss $ ( 16,943 ) $ ( 23,824 ) $ ( 32,463 ) $ ( 42,047 )
6 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 March 31, 2024, 7,645,076 potential ordinary shares issuable for stock options were excluded from the computation of diluted weighted-average shares outstanding because including them would have had an anti-dilutive effect (March 31, 2023:
−Removed: Property and Equipment, Net
−Removed: During the three months ended March 31, 2024, the Company’s additions to property and equipment, net were $ 0.4 million which primarily related to an increase in leasehold improvements from the Company’s U.S.
−Removed: office in Germantown, Maryland (three months ended March 31, 2023:
−Removed: $ 4.8 million).
−Removed: Depreciation expense for the three months ended March 31, 2024 was $ 0.6 million (three months ended March 31, 2023:
−Removed: $ 0.4 million, respectively).
+Added: 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:
BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Property and Equipment, Net
+Added: 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.
+Added: office (six months ended June 30, 2023:
+Added: $ 6.4 million, primarily related to an increase in leasehold improvements from the Company’s U.S.
+Added: office in Germantown, Maryland).
+Added: Depreciation expense for the three and six months ended June 30, 2024 was $ 0.7 million and $ 1.3 million, respectively (June 30, 2023:
+Added: three and six months $ 0.5 million and $ 0.9 million, respectively).
Intangible Assets, Net
−Removed: The gross amount of amortizable intangible assets, consisting of acquired developed technology, was $ 31.6 million as of March 31, 2024 and December 31 2023, respectively, and accumulated amortization was $ 7.3 million and $ 6.5 million as of March 31, 2024 and December 31, 2023, respectively.
−Removed: The amortization expense for the three months ended March 31, 2024 was $ 0.8 million (three months ended March 31, 2023:
−Removed: $ 0.8 million).
+Added: 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.
+Added: 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: $ 0.8 million and $ 1.6 million, respectively).
The estimated annual amortization expense is $ 3.2 million for the years 2024 through to 2031.
+Added: In June 2024, the Company announced plans 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: 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.
+Added: 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.
Prepaid Expenses and Other Current Assets (in thousands):
12 unchanged sentences
Total $ 10,278 $ 9,212
+Added: 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.
+Added: 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.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Coalition for Epidemic Preparedness Innovations (“CEPI”) Funding Agreement
5 unchanged sentences
Sales for the benefit of end users in specified low and middle income countries (“LMICs”) and upper and middle income countries (“UMICs”) are excluded from the calculations of net sales and net revenue.
−Removed: Sales of product for the benefit of end users in LMICs and UMICs are subject to tiered discounted pricing requirements under the Funding Agreement.
−Removed: The Company is further required to pay a mid-double digit percentage of any proceeds earned on any priority review voucher related to VTP-500 during the Royalty Period.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: For the period ended March 31, 2024, $ 1.6 million proceeds have been received and $ 0.2 million income has been recognized in relation to this contract.
−Removed: This is presented as other operating income in the Statements of Operations and Comprehensive Loss.
+Added: Sales of the product for the benefit of end users in LMICs and UMICs are subject to tiered discounted pricing requirements under the Funding Agreement.
+Added: The Company is further required to pay a low to mid-double-digit percentage of any proceeds earned on any priority review voucher related to VTP-500 during the Royalty Period.
+Added: 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.
+Added: This is presented as other operating income in the condensed consolidated statements of operations and comprehensive loss.
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 $ 1.4 million as at March 31, 2024 are reflected in Cash, cash equivalents and restricted cash in the condensed consolidated balance sheets until expenditures contemplated in the Funding Agreement are incurred.
+Added: 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.
Deferred income
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 statement of operations and comprehensive loss in the period in which such research and development activities are actually performed in a manner that satisfies the conditions of the Funding Agreement.
−Removed: Changes in the deferred income during the three months ended March 31, 2024 and 2023, are as follows (in thousands):
−Removed: Three Months Ended March 31,
+Added: 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.
+Added: Changes in deferred income during the three and six months ended June 30, 2024 and 2023, are as follows (in thousands):
+Added: Three months ended June 30, Six months ended June 30,
+Added: 2024 2023 2024 2023
Beginning balance $ 1,434 $ — $ — $ —
Cash payments received — — 1,629 —
−Removed: Other income recognized related to the Funding Agreement ( 205 ) —
+Added: Other operating income recognized related to the Funding Agreement ( 577 ) — ( 782 ) —
Foreign exchange translation ( 18 ) — ( 8 ) —
Ending balance $ 839 $ — $ 839 $ —
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Ordinary Shares
All ordinary shares rank pari passu as a single class.
−Removed: The following is a summary of the rights and privileges of the holders of ordinary shares as of March 31, 2024:
+Added: The following is a summary of the rights and privileges of the holders of ordinary shares as of June 30, 2024:
Liquidation preference:
11 unchanged sentences
, at least every five years ) to remain effective.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
On April 21, 2021, our shareholders approved the disapplication of preemptive rights for a period of five years from the date of approval by way of a special resolution of our shareholders.
14 unchanged sentences
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.
−Removed: The Company received shareholder approval on April 21, 2021 (pursuant to the shareholder resolutions passed on that date) in order to effect the transfer back and cancellation of the deferred shares for nil consideration in accordance with sections 659 and 662 of the Companies Act 2006.
+Added: The Company received shareholder approval on
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: April 21, 2021 (pursuant to the shareholder resolutions passed on that date) in order to effect the transfer back and cancellation of the deferred shares for nil consideration in accordance with sections 659 and 662 of the Companies Act 2006.
The Company’s deferred A shares with a nominal value of £ 1.00 each remain in issue for the purposes of satisfying the minimum share capital requirements for a public limited company as prescribed by the Companies Act 2006.
1 unchanged sentence
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 March 31, 2024, the Company had a contingent consideration liability of $ 1.9 million related to the acquisition of Avidea Technologies, Inc.
+Added: As of June 30, 2024, the Company had a contingent consideration liability of $ 1.9 million related to the acquisition of Avidea Technologies, Inc.
The fair value of the contingent consideration is a Level 3 valuation with the significant unobservable inputs being the probability of success of achievement of the milestones and the expected date of the milestone achievement.
Significant judgment is employed in determining the appropriateness of certain of these inputs.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 March 31,
+Added: Three months ended June 30, Six months ended June 30,
+Added: 2024 2023 2024 2023
Beginning balance $ 1,867 $ 1,710 $ 1,823 $ 1,711
−Removed: Change in fair value recognized in net loss/(gain) 60 ( 38 )
+Added: Change in fair value recognized in net loss 18 354 78 316
Foreign exchange translation recognized in other comprehensive loss 3 53 ( 13 ) 90
Ending balance $ 1,888 $ 2,117 $ 1,888 $ 2,117
−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.
−Removed: Therefore, the Company performed an interim qualitative assessment as of March 31, 2024 to determine whether it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
+Added: 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.
+Added: 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.
Based on this assessment, management determined it is not more likely than not that the fair value of the reporting unit is less than its carrying amount and hence no impairment loss has been recognized.
Share-Based Compensation
−Removed: During the three month period ended March 31, 2024, in accordance with the terms of the Annual Increase of the Barinthus Biotherapeutics plc Award Plan 2021 (the “Plan”), the total number of ordinary shares available for issuance under the Plan increased by 4 % of the Company’s issued and outstanding ordinary shares as of January 1, 2023.
−Removed: For the three months ended March 31, 2024, the Company granted 1,627,958 options to employees and directors with a weighted average grant date fair value of $ 2.90 and a weighted average exercise price of $ 3.67 per share (March 31, 2023:
+Added: 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.
+Added: 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:
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 three months ended March 31, 2024, 70,946 options (March 31, 2023:
+Added: For the six months ended June 30, 2024, 229,430 options (June 30, 2023:
217,860 ) were forfeited.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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: Three Months Ended March 31,
+Added: Six months ended June 30,
Expected volatility 108.7 % 97.2 %
2 unchanged sentences
Expected dividend yield — % — %
−Removed: As of March 31, 2024, 7,645,076 options with a weighted average exercise price of $ 6.20 were outstanding.
−Removed: As of March 31, 2024, there was $ 6.2 million unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 1.9 years.
−Removed: As of March 31, 2023, 6,807,859 options with a weighted average exercise price of $ 9.69 were outstanding.
+Added: As of June 30, 2024, 7,779,884 options with a weighted average exercise price of $ 6.19 were outstanding.
+Added: 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.
+Added: As of June 30, 2023, 6,781,099 options with a weighted average exercise price of $ 9.51 were outstanding.
Share based compensation expense is classified in the unaudited condensed consolidated statements of operations and comprehensive loss as follows (in thousands):
−Removed: Three Months Ended March 31,
+Added: Three months ended June 30, Six months ended June 30,
+Added: 2024 2023 2024 2023
Research and development $ 505 $ 1,027 $ 1,217 $ 2,146
1 unchanged sentence
Total $ 1,195 $ 1,990 $ 2,810 $ 4,212
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Commitments and Contingencies
7 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 three month periods ended March 31, 2024 and 2023.
+Added: 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.
The Company leases certain laboratory and office space under operating leases, which are described below.
4 unchanged sentences
The Company has provided the lessor with a refundable security deposit of $ 0.7 million which is included in Other assets.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Germantown, Maryland
On June 14, 2022, the Company entered into a lease agreement for the lease of approximately 19,700 square feet in Germantown, Maryland.
−Removed: The site will house the Company’s, state-of-the-art wet laboratory in the United States of America.
+Added: The site houses the Company’s state-of-the-art wet laboratory in the United States of America.
The lease expires on February 28, 2034, with the Company having a single right to extend for an additional five years on the same terms and conditions other than for the base rent.
−Removed: The Company has a rent-free period up to February 29, 2024, and is entitled to up to $ 3.5 million for leasehold improvements to the premises desired by the Company.
+Added: The Company had a rent-free period up to February 29, 2024, and was entitled to up to $ 3.5 million for leasehold improvements to the premises desired by the Company.
The Company has provided the lessor with a refundable security deposit of $ 0.2 million which is included in Other assets.
5 unchanged sentences
Lease liability, non-current $ 10,654 $ 11,191
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Three months ended March 31,
+Added: Six months ended June 30,
Other information
2 unchanged sentences
Weighted average discount rate 7.5 % 7.6 %
−Removed: Three months ended March 31,
+Added: Three months ended June 30, Six months ended June 30,
+Added: 2024 2023 2024 2023
Short-term lease costs $ — $ 151 $ — $ 303
−Removed: Fixed lease costs 359 279
+Added: Operating leases 358 316 717 595
Total lease cost $ 358 $ 467 $ 717 $ 898
−Removed: Future annual minimum lease payments under operating leases as of March 31, 2024, were as follows (in thousands):
+Added: Future annual minimum lease payments under operating leases as of June 30, 2024, were as follows (in thousands):
Remainder of 2024 $ 958
3 unchanged sentences
Total lease liability $ 12,570
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Other contingencies
3 unchanged sentences
Related Party Transactions
−Removed: During the three months ended March 31, 2024, the Company incurred expenses of $ 0.2 million (three months ended March 31, 2023:
−Removed: $ 0.1 million) from Oxford University Innovation Limited which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford.
−Removed: As of March 31, 2024, the Company owed $ 0.01 million (December 31, 2023:
−Removed: $ 0.002 million) to Oxford University Innovation Limited.
−Removed: During the three months ended March 31, 2024, the Company recognized license revenue of nil (three months ended March 31, 2023:
−Removed: $ 0.5 million), from Oxford University Innovation Limited.
−Removed: As of March 31, 2024, the Company was owed nil (December 31, 2023:
−Removed: nil ) from Oxford University Innovation Limited.
+Added: 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: $ 0.3 million and $ 0.4 million, respectively) from Oxford University Innovation Limited which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford.
+Added: 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:
+Added: $ 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, autoimmunity and cancer.
+Added: We are a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases and autoimmunity.
Helping patients and their families is the guiding principle at the heart of Barinthus Bio.
−Removed: We stand apart through our broad pipeline, built around four proprietary platform technologies;
−Removed: two viral vector platforms, ChAdOx and MVA;
−Removed: and two synthetic SNAP platforms, SNAP-Tolerance Immunotherapy, or SNAP-TI and SNAP-Cancer Immunotherapy, or SNAP-CI.
+Added: We stand apart through our focused pipeline, built around proprietary platform technologies;
+Added: viral vector-based, consisting of ChAdOx and MVA;
+Added: and synthetic, consisting of SNAP-Tolerance Immunotherapy, or SNAP-TI.
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 and cancers, or by dampening CD4+ and CD8+ T cells, and increasing regulatory T cells in autoimmunity.
−Removed: Harnessing our range of proprietary viral vector and synthetic platform technologies, we are advancing a pipeline of four product candidates across a diverse range of therapeutic areas, including:
−Removed: VTP-300, a Phase 2 immunotherapeutic candidate designed as a potential component of a functional cure for chronic infection;
+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 CD4+ and CD8+ T cells, and increasing regulatory T cells in autoimmunity.
+Added: 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.
+Added: These include:
+Added: 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;
+Added: and VTP-1000, our first preclinical autoimmune candidate designed to utilize the SNAP-TI platform to treat patients with celiac disease.
+Added: We have two other programs in infectious disease and cancer:
VTP-200, a Phase 2 nonsurgical product candidate for persistent high-risk HPV;
−Removed: VTP-1000, our first preclinical autoimmune candidate designed to utilize the SNAP-TI platform to treat patients with celiac disease;
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 in Middle East Respiratory Syndrome, or MERS, Zoster and Non-Small Cell Lung Cancer, or NSCLC.
−Removed: We also coinvented a COVID-19 vaccine with the University of Oxford, which has been exclusively licensed worldwide to AstraZeneca.
−Removed: The co-invention of the COVID-19 vaccine demonstrated our ability to navigate a changing environment with speed and efficiency and lead the way in responding to urgent medical needs, as well as providing a strong proof of concept for the ChAdOx platform.
−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 infectious diseases, autoimmune-disorders and cancers that have a significant impact on their every day lives.
−Removed: On August 9, 2022, we filed a Registration Statement on Form S-3, as amended, or the Shelf, with the Securities and Exchange Commission in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million.
+Added: 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.
+Added: We also co-invented a COVID-19 vaccine with the University of Oxford, which was exclusively licensed worldwide to AstraZeneca.
+Added: We believe our proven scientific expertise, diverse portfolio and focus on product candidate development uniquely positions us to navigate towards delivering treatments for patients with chronic infectious diseases and autoimmune-disorders that have a significant impact on their every day lives.
+Added: On August 9, 2022, we filed a Registration Statement on Form S-3, as amended, or the Shelf, with the Securities and Exchange Commission in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by American Depositary Shares, or ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million.
The Shelf was declared effective on August 17, 2022.
We also simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, providing for the offering, issuance and sale by us of up to an aggregate of $75.0 million of our ordinary shares represented by ADSs from time to time in “at-the-market” offerings under the Shelf.
−Removed: As of March 31, 2024, we have sold 1,329,260 ordinary shares represented by ADSs under the sales agreement, amounting to net proceeds of $3.5 million.
+Added: 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.
We incurred net losses each year since inception through to December 31, 2021.
1 unchanged sentence
For the year ended December 31, 2023, we generated a net loss of $73.4 million.
−Removed: For the three months ended March 31, 2024, we incurred a net loss of $15.5 million.
−Removed: As of March 31, 2024, we had an accumulated deficit of $192.1 million and we do not currently expect positive cash flows from operations in the foreseeable future.
+Added: For the three and six months ended June 30, 2024, we incurred a net loss of $17.0 million and $32.5 million, respectively.
+Added: 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.
We expect to incur net operating losses for at least the next several years as we advance our product candidates through clinical development, seek regulatory approval, prepare for approval, and in some cases proceed to commercialization of our product candidates, as well as continue our research and development efforts and invest to establish a commercial manufacturing facility, as and when appropriate.
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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.
−Removed: Based on our research and development plans, we expect that our existing cash, cash equivalents and restricted cash and other financial resources, will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025.
+Added: 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.
These estimates are based on assumptions that may prove to be wrong, and we could use our available capital resources more quickly than we expect.
1 unchanged sentence
If we are unable to raise additional funds when needed, we would be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
−Removed: Recent Development
+Added: Recent Developments
These are estimated timelines only and our pipeline may be subject to change.
−Removed: Celiac disease
−Removed: In April 2024, IND clearance was received from the FDA to progress VTP-1000 in a first in human clinical trial in Celiac disease.
−Removed: GLU001 is a randomized, placebo-controlled Phase 1 trial with a controlled gluten challenge to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000 in adults with celiac disease.
−Removed: The study is designed in two parts;
−Removed: a single ascending dose part followed by a multiple ascending dose part, each randomized and placebo-controlled with three dose levels.
−Removed: The primary endpoint is assessment of the safety and tolerability of single and multiple dosing, and determination of a dose and schedule for further investigation.
−Removed: The trial also aims to demonstrate proof-of-principle of induction of immune tolerance and early proof-of-concept for VTP-1000 as a potential treatment for celiac disease based on assessment of pharmacodynamics and preliminary efficacy determined by means of a controlled gluten challenge.
−Removed: This Phase 1 trial has also received Ethics Committee approval to proceed in Australia.
−Removed: Topline Data from Phase 1b/2 APOLLO Trial of VTP-200 in Persistent High-Risk Human Papillomavirus ("hrHPV") Infections
−Removed: On April 18, 2024, we announced topline final data from the APOLLO trial, (also known as HPV001) a Phase 1b/2 dose-ranging study of VTP-200 in women with low-grade cervical lesions associated with persistent hrHPV infection.
−Removed: APOLLO was a randomized, placebo-controlled Phase 1b/2 multi-center trial of 108 participants across the UK and EU evaluating the safety, tolerability and immunogenicity of VTP-200 in women aged 25-55 with persistent hrHPV infection and low-grade cervical lesions.
−Removed: The primary objective was to evaluate the safety and tolerability of VTP-200.
−Removed: The trial was also designed to assess the effect of VTP-200 on clearance of hrHPV infection and cervical lesion(s), as well as select appropriate doses for further development.
−Removed: The APOLLO study met its primary safety endpoint, demonstrating that VTP-200 was generally well-tolerated and was administered with no treatment-related grade 3 or higher unsolicited AEs and no treatment-related SAEs.
−Removed: The highest hrHPV clearance rate of 60% at Month 12 was observed in group 2, which included the highest dose of ChAdOx, compared to a 33% clearance rate in the placebo group.
−Removed: Groups 1, 3, 4 and 5 showed 12%, 11%, 33% and 36% hrHPV clearance rates, respectively.
−Removed: The study also evaluated cervical lesion clearance rates in participants with both reported lesions at screening and visualization of the cervical transformation zone at 12 months (n=57).
−Removed: The highest cervical lesion clearance rate of 67% was observed in group 2 and group 5, both received the highest dose of ChAdOx, compared to 39% in the placebo group.
−Removed: Groups 1, 3 and 4 showed 40%, 20% and 33% cervical lesion clearance rates, respectively.
−Removed: Pooled data from the five active dose groups showed no significant improvement in hrHPV clearance or cervical lesion clearance rates in comparison to the placebo group.
−Removed: Future development options for the VTP-200 program are currently being evaluated with further analyses ongoing.
−Removed: Management Team
−Removed: On May 1, 2024, we announced the appointment of Dr.
−Removed: Leon Hooftman as Chief Medical Officer.
−Removed: Hooftman will join the company on June 3, 2024, and brings significant drug development expertise across a broad array of therapeutic areas including immunology, autoimmunity, hematology, oncology and infectious diseases.
−Removed: VTP-300 interim data update at the European Association for the Study of the Liver ("EASL") Congress
−Removed: On June 5-8, 2024, we will present interim data at the EASL Congress in Milan, Italy, following the acceptance of an abstract on HBV003, an ongoing Phase 2b trial designed to further evaluate the safety and efficacy of VTP-300 when combined with a low-dose anti-PD-1 antibody, and standard-of-care (SoC) nucleos(t)ide analogue (NUC) therapy.
−Removed: An abstract has also been accepted at the EASL Congress for interim data from the Phase 2a AB-729-202 trial combining Arbutus Biopharma Corporation’s RNAi therapeutic candidate, imdusiran (AB-729), with Barinthus Bio’s T cell stimulating immunotherapeutic candidate, VTP-300, and SoC NUC therapy.
−Removed: Impact of Israel and Gaza Conflict
−Removed: In respect of the international situation in Israel and Gaza, we have no operations or suppliers based in Israel or Gaza, and as a result, as of the date of this Quarterly Report on Form 10-Q, we believe the impact on our business, operations and financial condition will be minimal.
−Removed: Impact of the Ukraine Crisis
−Removed: In respect of the international situation in Ukraine, we have no operations or suppliers based in Ukraine, Belarus or Russia, and as a result, as of the date of this Quarterly Report on Form 10-Q, we believe the impact on our business, operations and financial condition will be minimal.
+Added: 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.
+Added: 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.
+Added: Interim HBV003 data:
+Added: VTP-300 and Low-dose Nivolumab
+Added: 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.
+Added: 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.
+Added: 67% of participants across all groups assessed for NUC discontinuation had HBsAg <10 IU/mL at Week 24 or later.
+Added: Robust T cell responses were observed to all VTP-300 encoded antigens.
+Added: There were no Serious Adverse Events, or SAEs, Grade 3 or 4 Adverse Events, or AEs, related to treatment.
+Added: Interim IM-PROVE II data:
+Added: imdusiran and VTP-300
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Treatment with imdusiran and VTP-300 was generally well-tolerated, with no SAEs or treatment discontinuations reported.
+Added: 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.
+Added: Impact of Israel and Gaza Conflict and Ukraine Crisis
+Added: 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.
Impact of Global Economic Conditions and Inflationary Pressures
Instability in global economic conditions and geopolitical matters, as well as volatility in financial markets, could have a material adverse effect on our results of operations and financial condition.
−Removed: These inflationary pressures and rising interest rates in the United States, the United Kingdom and elsewhere have given rise to increasing concerns that the U.S., U.K.
−Removed: and other economies are now in, or may soon enter, economic recession.
−Removed: Sustained inflationary pressures, increased interest rates, an economic recession or continued or intensified disruptions in the global financial markets could adversely affect our future financing capability or ability to access the capital markets.
+Added: These inflationary pressures and volatile interest rates in the United States, the United Kingdom and elsewhere have given rise to increasing concerns that the U.S., U.K.
+Added: and other economies are now in, or may enter, economic recession.
+Added: Sustained inflationary pressures, volatile interest rates, an economic recession or continued or intensified disruptions in the global financial markets could adversely affect our future financing capability or ability to access the capital markets.
Additionally, we may incur future increases in operating costs due to additional inflationary increases.
5 unchanged sentences
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 months ending March 31, 2024 was nil (three months ending March 31, 2023:
−Removed: $0.5 million), representing the amounts we have been notified of as due by OUI to date and an estimate of future receipts, constrained to the extent that it is probable that a significant reversal of revenue would not occur.
−Removed: In May 2024, AstraZeneca announced its planned withdrawal of Vaxzevria as demand had declined, and therefore we do not expect to receive any significant future revenue relating to commercial sales of Vaxzevria.
+Added: Our revenue for the three and six months ended June 30, 2024 was nil (three and six months ended June 30, 2023:
+Added: $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.
+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 commercial sales of Vaxzevria.
Operating Expenses
1 unchanged sentence
Research and Development Expenses
−Removed: Since our inception, we have focused significant resources on our research and development activities, including establishing and building on our adenovirus platform, further enhancing our in-licensed ChAdOx1, ChAdOx2 and MVA vectors, developing a new next-generation adenoviral vector, acquiring new technology platforms including SNAP (SNAP-TI and SNAP-CI), conducting preclinical studies, developing various manufacturing processes, and advancing clinical development of our programs including Phase 2 clinical trials for VTP-100, which we subsequently discontinued development of, as well as initiating the clinical trials for VTP-200, VTP-300, VTP-600 and VTP-850 and readying VTP-500, 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,
+Added: 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.
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.
10 unchanged sentences
When determining the fair value of contingent consideration, significant judgment is used to determine the probability of success of achievement of the technology and clinical milestones and the date of the expected milestone.
−Removed: We expect our general and administrative expenses to continue
−Removed: to increase in the future as we expand our operating activities in both the United Kingdom and United States and potentially prepare for manufacturing and/or commercialization of our current and future product candidates.
−Removed: These costs will increase as our headcount rises to allow full support for our operations as a public company, including increased expenses related to legal, accounting, regulatory and tax-related services associated with maintaining compliance with requirements of the Nasdaq Global Market and the Securities and Exchange Commission, directors’ and officers’ liability insurance premiums and investor relations activities.
+Added: We expect our general and administrative expenses to continue to increase in the future as we expand our operating activities in both the United Kingdom and United States and potentially prepare for manufacturing and/or commercialization of our current and future product candidates.
+Added: These costs will increase if our headcount rises to allow full support for our operations as a public company, including increased expenses related to legal, accounting, regulatory and tax-related services associated with maintaining compliance with requirements of the Nasdaq Global Market and the Securities and Exchange Commission, directors’ and officers’ liability insurance premiums and investor relations activities.
Other Operating Income
2 unchanged sentences
Payments received in advance of incurring reimbursable expenses are recorded as deferred income.
−Removed: Any remaining unused amounts of the cash payments received on the balance sheet will be disclosed as restricted cash in the notes of the financial statement.
+Added: Any remaining unused amounts of the cash payments received on the balance sheets will be disclosed as restricted cash in the notes of the condensed consolidated financial statements.
Other Income/(Expense)
7 unchanged sentences
We benefit from the United Kingdom research and development tax credit regime, being the Small and Medium-sized Enterprises R&D tax relief program, or SME Program, and, to the extent that our projects are grant funded or relate to work subcontracted to us by third parties, the Research and Development Expenditure Credit program, or RDEC Program.
−Removed: Until March 2023 under the SME program, we were able to surrender some of its trading losses that arise from qualifying research and development activities for a cash rebate of up to 33.35% of such qualifying research and development expenditure.
+Added: Until March 2023 under the SME program, we were able to surrender some of our trading losses that arise from qualifying research and development activities for a cash rebate of up to 33.4% of such qualifying research and development expenditure.
Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects.
2 unchanged sentences
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 current SME Programs.
+Added: We are assessing if we can claim under the loss-making R&D Intensive Scheme for SMEs, which will provide benefits consistent with those claimed under the previous SME Program.
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.
1 unchanged sentence
Further, the U.K.
−Removed: Finance Act of 2021 introduced a cap on payable credit claims under the SME Program in excess of
−Removed: £20,000 with effect from April 2021 by reference to, broadly, three times our the total Pay As You Earn, or PAYE, and National Insurance Contributions, or NICs, liability, subject to an exception which prevents the cap from applying.
+Added: Finance Act of 2021 introduced a cap on payable credit claims under the SME Program in excess of £20,000 with effect from April 2021 by reference to, broadly, three times the total Pay As You Earn, or PAYE, and National Insurance Contributions, or NICs, liability, subject to an exception which prevents the cap from applying.
That exception requires us to create, take steps to create or manage intellectual property, as well as having qualifying research and development expenditure in respect of connected parties, which does not exceed 15% of the total claimed.
15 unchanged sentences
Because there are inherent uncertainties involved in these factors, significant differences between these estimates and actual results could result in future impairment charges and could materially impact our future financial results.
−Removed: The goodwill of $12.2 million recognized as of March 31, 2024 related to the acquisition of Avidea on December 10, 2021.
−Removed: We performed an interim assessment as of March 31, 2024 to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount.
−Removed: Based on this assessment, we have not recognized any impairment losses related to goodwill for the three months ending March 31, 2024.
+Added: The goodwill of $12.2 million recognized as of June 30, 2024 related to the acquisition of Avidea on December 10, 2021.
+Added: 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.
+Added: 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.
+Added: Based on this assessment, management determined it is not more likely than not that the fair value of the reporting unit is less than its carrying amount and hence no impairment loss related to goodwill has been recognized related to goodwill for the three and six months ended June 30, 2024.
Long-lived assets
2 unchanged sentences
In the event such cash flows are not expected to be sufficient to recover the carrying amount of the asset or asset group, the assets are written down to their estimated fair values.
−Removed: No such impairments were recorded during the three months ended March 31, 2024.
+Added: In June 2024, the Company announced plans 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: 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.
+Added: 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.
Contingent consideration
8 unchanged sentences
Results of Operations
−Removed: Comparison of the Three Months Ended March 31, 2024 and 2023
+Added: Comparison of the Three Months Ended June 30, 2024 and 2023
The following table sets forth the significant components of our results of operations (in thousands):
−Removed: Three months ended March 31, 2024 Three months ended March 31, 2023 Change
−Removed: Revenue from Licenses, Grants & Services $ — $ 468 $ (468)
+Added: Three months ended June 30, 2024 Three months ended June 30, 2023 Change
+Added: License revenue 1
+Added: $ — $ 334 $ (334)
Operating expenses:
−Removed: Research & development 11,125 9,814 1,311
+Added: Research and development
+Added: 11,662 13,543 (1,881)
General and administrative 7,201 13,128 (5,927)
12 unchanged sentences
$ (16,943) $ (23,824) $ 6,881
−Removed: For the three months ended March 31, 2024, and 2023, our revenue consisted of nil and $0.5 million respectively, from the OUI License Agreement Amendment with respect to payments from OUI in connection with commercial sales of Vaxzevria.
−Removed: The decrease in revenue from the OUI License Agreement Amendment, compared to the prior period, resulted from substantially declined sales of Vaxzevria due to a decrease in demand.
−Removed: In May 2024, AstraZeneca announced its planned withdrawal of Vaxzevria as demand had declined, and therefore we do not expect to receive any significant future revenue relating to commercial sales of Vaxzevria.
+Added: 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.
Research and Development Expenses
−Removed: The following table summarizes our research and development expenses for the three months ended March 31, 2024 and 2023 (in thousands):
−Removed: 31, 2024 Three months
−Removed: 31, 2023 Change
+Added: The following table summarizes our research and development expenses for the three months ended June 30, 2024 and 2023 (in thousands):
+Added: Three Months Ended June 30, 2024 Three Months Ended June 30, 2023 Change
Direct research and development expenses by program:
3 unchanged sentences
VTP-600 NSCLC 2
+Added: VTP-850 Prostate cancer 414 242 172
+Added: VTP-1000 Celiac 3
1,371 3,018 (1,647)
+Added: Other and earlier stage programs 908 701 207
+Added: Total direct research and development expenses 6,438 9,634 (3,196)
+Added: Indirect research and development expenses:
+Added: Personnel-related (including share-based compensation) 4,763 3,388 1,375
+Added: Facility related 342 202 140
+Added: Other indirect costs 119 319 (200)
+Added: Total indirect research and development expenses 5,224 3,909 1,315
+Added: Total research and development expenses $ 11,662 $ 13,543 $ (1,881)
+Added: 1 The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).
+Added: 2 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK.
+Added: 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.
+Added: 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.
+Added: Our research and development expenses for the three months ended June 30, 2024 and 2023 were $11.7 million and $13.5 million, respectively.
+Added: 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.
+Added: 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.
+Added: Indirect research and development expenses for the three months ended June 30, 2024 and 2023 were $5.2 million and $3.9 million, respectively.
+Added: 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: General and Administrative Expenses
+Added: General and administrative expenses for the three months ended June 30, 2024 and 2023 were $7.2 million and $13.1 million, respectively.
+Added: 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: Other Operating Income
+Added: 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: Interest Income
+Added: 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: Research and Development Incentives
+Added: For the three months ended June 30, 2024 and 2023 research and development incentives were $0.7 million and $0.6 million, respectively.
+Added: Such research and development incentives relate to corporation tax relief on research and development projects incentive programs in the United Kingdom.
+Added: 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.
+Added: Comparison of the six months ended June 30, 2024 and 2023
+Added: The following table sets forth the significant components of our results of operations (in thousands):
+Added: Six months ended June 30, 2024 Six months ended June 30, 2023 Change
+Added: License Revenue 1
+Added: $ — $ 802 $ (802)
+Added: Operating expenses:
+Added: Research and development
+Added: 22,787 23,357 (570)
+Added: General and administrative 13,195 25,266 (12,071)
+Added: Total operating expenses 35,982 48,623 (12,641)
+Added: Other operating income 782 — 782
+Added: Loss from operations
+Added: (35,200) (47,821) 12,621
+Added: Other income/(expense)
+Added: Interest income 1,410 2,110 (700)
+Added: Interest expense (24) (14) (10)
+Added: Research and development incentives 1,287 1,716 (429)
+Added: Other income, net
+Added: Total other income 2,693 4,122 (1,429)
+Added: Loss before income tax
+Added: (32,507) (43,699) 11,192
+Added: Tax benefit 44 1,652 (1,608)
+Added: $ (32,463) $ (42,047) $ 9,584
+Added: 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: Research and Development Expenses
+Added: The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023 (in thousands):
+Added: Six months ended June 30, 2024 Six months ended June 30, 2023 Change
+Added: Direct research and development expenses by program:
+Added: VTP-200 HPV $ 1,636 $ 3,175 $ (1,539)
+Added: VTP-300 HBV 4,947 5,875 (928)
+Added: VTP-500 MERS 1
+Added: VTP-600 NSCLC 2
+Added: 188 354 (166)
VTP-850 Prostate cancer 592 457 135
VTP-1000 Celiac 3
+Added: 2,744 4,590 (1,846)
Other and earlier stage programs 1,693 981 712
8 unchanged sentences
2 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK.
−Removed: Research and development expenses related to VTP-1100 HPV Cancer were previously included with VTP-1000 Celiac but are now included in 'Other and earlier stage programs' because we are focusing resources on other clinical programs and deferring the planned IND application for VTP-1100 in HPV cancer.
−Removed: Our research and development expenses for the three months ended March 31, 2024 and 2023 were $11.1 million and $9.8 million, respectively.
−Removed: Direct expenses for the three months ended March 31, 2024 and 2023 were $5.8 million and $5.8 million, respectively, and consisted of outside services, consultants, laboratory materials, clinical trials, manufacturing of clinical trial materials, as well as costs for external preclinical services and sample testing.
−Removed: Of the $0.04 million increase, $0.5 million pertains to an increase in other and earlier stage programs mainly due to the reclassification of VTP-1100 HPV cancer cost in the current period to other earlier stage programs.
−Removed: These increases were partially offset by $0.1 million decrease in VTP-200 HPV and $0.2 million for VTP-300 HBV due to a reduction in clinical trial and manufacturing development costs.
−Removed: Indirect research and development expenses for the three months ended March 31, 2024 and 2023 were $5.3 million and $4.0 million, respectively.
−Removed: Of the $1.3 million increase, $0.7 million related to an increase in headcount across locations in the United Kingdom and United States and $0.5 million increase in other indirect costs was primarily due to research and development overhead costs related to the new U.S.
−Removed: laboratory and office facility that we relocated to in June 2023.
+Added: 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.
+Added: 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.
+Added: Our research and development expenses for the six months ended June 30, 2024 and 2023 were $22.8 million and $23.4 million, respectively.
+Added: 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.
+Added: 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.
+Added: Indirect research and development expenses for the six months ended June 30, 2024 and 2023 were $10.5 million and $7.9 million, respectively.
+Added: 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.
General and Administrative Expenses
−Removed: General and administrative expenses for the three months ended March 31, 2024 and 2023 were $6.0 million and $12.1 million, respectively.
−Removed: The decrease of $6.1 million relates primarily to a gain of $1.2 million on foreign exchange for the three months ended March 31, 2024, compared to a loss of $3.5 million for the three months ended March 31, 2023 a decrease in personnel expenses, including share-based payment charges of $0.8 million, primarily due to a reduction in non-cash share-based payment charges, and a decrease in insurance costs of $0.9 million due to a reduction in insurance premiums.
+Added: General and administrative expenses for the six months ended June 30, 2024 and 2023 were $13.2 million and $25.3 million, respectively.
+Added: 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: laboratory in June 2023.
Other Operating Income
−Removed: For the three months ended March 31, 2024 and 2023, other operating income was $0.2 million and nil, respectively, resulting from the funding provided by CEPI under the Funding Agreement, dated December 20, 2023, entered into by and among us, the Chancellors, Masters and Scholars of the University of Oxford and the CEPI in the three months ended March 31, 2024.
+Added: 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.
Interest Income
−Removed: For the three months ended March 31, 2024 and 2023, interest income was $0.8 million and $1.6 million, respectively, resulting from the interest earned on our short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.
+Added: 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.
Research and Development Incentives
−Removed: For the three months ended March 31, 2024 and 2023 research and development incentives were $0.6 million and $1.2 million, respectively.
+Added: For the six months ended June 30, 2024 and 2023 research and development incentives were $1.3 million and $1.7 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 March 31, 2024 and 2023, the tax benefit was $0.04 million and $0.5 million respectively, which primarily relates to movements in deferred tax.
+Added: The decrease of $0.4 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: 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: 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.
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 March 31, 2024, we received gross proceeds of approximately $328.4 million from the issuance of our ordinary and preferred shares and convertible loan notes.
−Removed: As of March 31, 2024, we had cash, cash equivalents and restricted cash of $130.0 million.
+Added: 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.
+Added: As of June 30, 2024, we had cash, cash equivalents and restricted cash of $117.8 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 March 2024, we raised net proceeds of $3.5 million from the issuance of shares represented by ADSs through “at-the-market” offerings under the sales agreement with Jefferies LLC.
+Added: • 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.
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 March 31, 2024, we have sold 1,329,260 ordinary shares represented by ADSs under the sales agreement amounting to net proceeds of $3.5 million.
+Added: 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.
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: 31, 2024 Three months
−Removed: ended March 31, 2023
+Added: Six months ended June 30, 2024 Six months ended June 30, 2023
Net cash used in operating activities $ (23,828) $ (20,131)
4 unchanged sentences
Cash Used in Operating Activities
−Removed: During the three months ended March 31, 2024, net cash used in operating activities was $11.8 million, primarily resulting from our net loss of $15.5 million adjusted by share based compensation of $1.6 million, depreciation and amortization of $1.4 million, non-cash lease expenses of $0.4 million, unrealized foreign exchange gain of $1.0 million and changes in our operating assets and liabilities, net of $1.3 million primarily related to a $1.9 million decrease in prepaid expenses and other current assets, $1.4 million increase in deferred revenue, a $0.8 million decrease in accrued expenses, $0.5 million decrease in accounts payable and $0.3 million decrease in operating lease liabilities.
−Removed: During the three months ended March 31, 2023, net cash used in operating activities was $3.2 million, primarily resulting from our net loss of $18.2 million adjusted by share based compensation of $2.2 million, depreciation and amortization of $1.2 million, foreign exchange loss of $3.5 million, and changes in our operating assets and liabilities, net of $8.3 million.
+Added: 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.
+Added: 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.
Net Cash Used in Investing Activities
−Removed: During the three months ended March 31, 2024 and 2023, cash used in investing activities was $0.3 million and $2.5 million, respectively.
−Removed: These amounts resulted primarily from capital expenditures related to leasehold improvements on our new office in Germantown, Maryland, United States.
−Removed: Net Cash Provided by/(Used in) Financing Activities
−Removed: During the three months ended March 31, 2024 and 2023, cash provided by financing activities was $0.5 million and $1.7 million, respectively.
+Added: During the six months ended June 30, 2024 and 2023, cash used in investing activities was $0.5 million and $5.5 million, respectively.
+Added: 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: Net Cash Provided by Financing Activities
+Added: During the six months ended June 30, 2024 and 2023, cash provided by financing activities was $0.9 million and $1.7 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 three months ended March 31, 2024 and 2023, the effect of foreign exchange on cash, cash equivalents and restricted cash was a loss of $0.5 million and a gain of $1.0 million respectively, primarily as a result of fluctuations between the United States dollar and pound sterling exchange rates.
+Added: 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.
Future Funding Requirements
2 unchanged sentences
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 March 31, 2024.
−Removed: As of March 31, 2024, we had an accumulated deficit of $192.1 million.
+Added: We were profitable in 2022, however we have negative operating cash flows for the period ended June 30, 2024.
+Added: As of June 30, 2024, we had an accumulated deficit of $209.0 million.
We expect to continue to incur significant losses and negative cash flows from operations for the foreseeable future.
15 unchanged sentences
We may require substantial additional financing in the future to meet any such unanticipated factors and a failure to obtain this necessary capital could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
−Removed: Since our foundation, we have invested a significant portion of our efforts and financial resources in research and development activities for our ChAdOx1, ChAdOx2 and MVA technologies, acquisition of additional complementary platforms such as SNAP-TI and SNAP-CI, development of new technologies in house, and our product candidates derived from these technologies.
+Added: Since our foundation, we have invested a significant portion of our efforts and financial resources in research and development activities for our viral vector platform (ChAdOx and MVA), acquisition of additional complementary platforms such as SNAP-TI, development of new technologies in house, and our product candidates derived from these technologies.
Preclinical studies and especially clinical trials and additional research and development activities will require substantial funds to complete.
8 unchanged sentences
• the timing of success achieved and the costs involved in obtaining regulatory and marketing approvals and developing our ability to establish license or sale transactions and/or sales and marketing capabilities, if any, for our current and future product candidates if clinical trials and approval processes are successful;
−Removed: • the success of our collaborations with CanSino, CRUK and the Ludwig Institute and any future collaboration partners;
+Added: • the success of our collaborations with CEPI, Oxford University, Arbutus, CanSino, CRUK and the Ludwig Institute and any future collaboration partners;
• our ability to establish and maintain collaborations, strategic licensing or other arrangements and the financial terms of such agreements;
6 unchanged sentences
Unless and until we can generate a substantial amount of revenue from our product candidates, we expect to finance our future cash needs through public or private equity offerings, debt financings, collaborations, licensing arrangements or other sources, or any combination of the foregoing.
−Removed: Based on our research and development plans, we expect that our existing cash, cash equivalents and restricted cash and other financial resources, will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025.
+Added: 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.
These estimates are based on assumptions that may prove to be wrong, and we could use our available capital resources more quickly than we expect.
6 unchanged sentences
These contracts are generally cancellable by us upon prior notice.
−Removed: Payments due upon
−Removed: cancellation consist only of payments for services provided or expenses incurred, including noncancellable obligations of our service providers, up to the date of cancellation.
+Added: Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancellable obligations of our service providers, up to the date of cancellation.
We have contingent payment obligations that we may incur upon achievement of clinical, regulatory and commercial milestones, as applicable, or royalty payments that we may be required to make under our licenses;
−Removed: however, the amount, timing and likelihood of such payments are not known as of March 31, 2024.
+Added: however, the amount, timing and likelihood of such payments are not known as of June 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.