What changed in this filing

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Item 1A. Risk Factors

2024-05-13 compared with 2023-11-09 · 12 added, 12 removed, 27 unchanged (47% of the section changed)

Item 1A Risk Factors.

There have been no material changes from the risk factors previously disclosed in the Company’s most recent Annual Report on Form 10-K as filed with the SEC on March 24, 2023.

There have been no material changes from the risk factors previously disclosed in our most recent Annual Report on Form 10-K as filed with the SEC on March 20, 2024.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

5 unchanged sentences

• the success, cost and timing of our product development activities and clinical trials;

● the timing, scope or likelihood of regulatory filings and approvals, including timing of Investigational New Drug Application and Biological License Application filings for our current and future product candidates, and final U.S.

Food and Drug Administration, European Medicines Agency, United Kingdom Medicines and Healthcare products Regulatory Agency or other foreign regulatory authority approval of our current and future product candidates;

• the timing, scope or likelihood of regulatory filings and approvals, including timing of Investigational New Drug Application, or IND and Biological License Application filings for our current and future product candidates, and final U.S.

Food and Drug Administration, or FDA, European Medicines Agency, or EMA, United Kingdom Medicines and Healthcare products Regulatory Agency, or MHRA, or other foreign regulatory authority approvals relating to our current and future product candidates;

• our ability to develop and advance our current and future product candidates and programs into, and successfully complete, clinical trials;

● our ability to establish future or maintain current collaborations or strategic relationships or obtain additional funding;

• our ability to establish future or maintain current collaborations or strategic relationships;

• the rate and degree of market acceptance and clinical utility of our current and future product candidates;

● any expectations surrounding the payments we could potentially receive pursuant to the AstraZeneca License Agreement;

• any expectations surrounding the payments we could potentially receive pursuant to our collaborations and license agreements;

• the ability and willingness of our third-party collaborators to continue research and development activities relating to our product candidates;

● our and our collaborators’ ability to obtain, maintain, defend and enforce our intellectual property protection for our product candidates, and the scope of such protection;

• our ability to obtain, maintain, defend and enforce our intellectual property protection for our product candidates, and the scope of such protection;

• our manufacturing, commercialization and marketing capabilities and strategy;

● future agreements with third parties in connection with the commercialization of our product candidates and any other approved products;

• future agreements with third parties in connection with the commercialization of our product candidates, if approved, and any other approved products;

• regulatory developments in the United States and foreign countries;

4 unchanged sentences

• our expectations about market trends;

● the impact of global economic and political developments on our business, including rising or sustained high inflation and capital market disruptions, the current conflict in Ukraine, the conflict in Israel and Gaza, disruptions in the banking industry, economic sanctions and economic slowdowns or recessions that may result from such developments which could harm our research and development efforts as well as the value of our ordinary shares and ability to access capital markets;

● our expectations regarding the period during which we qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, as amended.

• our ability to anticipate and overcome challenges posed to the conduct of our business in the event of a global pandemic, such as COVID-19, or similar event;

• the impact of global economic and political developments on our business, including rising or sustained high inflation and capital market disruptions, the conflict in Ukraine, the conflict in Israel and Gaza, disruptions in the banking industry, economic sanctions and economic slowdowns or recessions that may result from such developments;

• our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act.

If our forward-looking statements prove to be inaccurate, the inaccuracy may be material.

6 unchanged sentences

Unless the context otherwise requires, reference in this Quarterly Report to the terms “Barinthus Bio,” “the Company,” “we,” “us,” “our,” and similar designations refer to Barinthus Biotherapeutics plc and, where appropriate, our wholly-owned subsidiaries.

shall refer to Vaccitech North America, Inc., (iv) Barinthus Biotherapeutics Switzerland GmbH shall refer to Vaccitech Switzerland GmbH and (v) Barinthus Biotherapeutics Italia S.R.L.

As used herein, all references before November 7, 2023 to (i) Barinthus Biotherapeutics plc shall refer to Vaccitech plc, (ii) Barinthus Biotherapeutics (UK) Limited shall refer to Vaccitech (UK) Limited, (iii) Barinthus Biotherapeutics North America, Inc., or Barinthus Bio NA shall refer to Vaccitech North America, Inc., (iv) Barinthus Biotherapeutics Switzerland GmbH shall refer to Vaccitech Switzerland GmbH (v) Barinthus Biotherapeutics S.R.L.

shall refer to Vaccitech Italia S.R.L.

after which the name change described herein shall have taken effect.

and (vi) Barinthus Biotherapeutics Pty Limited shall refer to Vaccitech Australia Pty Limited, after which the name change described herein shall have taken effect.

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.

What changed 10-Q

Item 1A. Risk Factors