Barinthus Biotherapeutics Files 8-K

TL;DR

Barinthus (fka Vaccitech) filed an 8-K, looks like standard reporting, no major news yet.

AI Summary

On April 18, 2024, Barinthus Biotherapeutics plc filed an 8-K report. The filing primarily concerns other events and financial statements/exhibits, with no specific material events detailed in the provided text. The company, formerly known as Vaccitech plc, is incorporated in England and Wales and operates in the pharmaceutical preparations sector.

Why It Matters

This 8-K filing indicates routine corporate reporting by Barinthus Biotherapeutics, formerly Vaccitech plc, without disclosing specific material events in the provided excerpt.

Risk Assessment

Risk Level: low — The provided text is a standard 8-K filing header and does not contain information about material events, financial performance, or significant business changes that would indicate a high or medium risk.

Key Players & Entities

• Barinthus Biotherapeutics plc (company) — Registrant
• Vaccitech plc (company) — Former company name
• Vaccitech Ltd (company) — Former company name
• April 18, 2024 (date) — Date of report

FAQ

Filing Documents

• brns-20240418.htm (8-K) — 36KB
• brns-20240418xexx991.htm (EX-99.1) — 25KB
• a1.jpg (GRAPHIC) — 5KB
• 0001828185-24-000022.txt ( ) — 250KB
• brns-20240418.xsd (EX-101.SCH) — 3KB
• brns-20240418_def.xml (EX-101.DEF) — 17KB
• brns-20240418_lab.xml (EX-101.LAB) — 29KB
• brns-20240418_pre.xml (EX-101.PRE) — 17KB
• brns-20240418_htm.xml (XML) — 4KB

01. Other Events

Item 8.01. Other Events. On April 18, 2024, Barinthus Biotherapeutics plc (the "Company") issued a press release titled "Barinthus Bio Announces Topline Data from Phase 1b/2 APOLLO Trial of VTP-200 in Persistent High-Risk Human Papillomavirus (HPV) Infections" announcing topline final data from APOLLO (also known as HPV001), a completed 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 high-risk (hr) HPV infection and low-grade cervical lesions. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on form 8-K. Study APOLLO: VTP-200 The primary objective of the trial was to evaluate the safety and tolerability of VTP-200. 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. The study consisted of an open label, non-randomized, dose escalation lead-in phase (n=9), followed by a blinded, randomized main phase (n = 99; 67 randomized to VTP-200 and 32 to placebo). Participant groups were dosed sequentially with ChAdOx and MVA 28 days apart, as follows: Group 1, ChAdOx 2x10 9 viral particles (vp), MVA 1x10 7 plaque-forming units (pfu); Group 2, ChAdOx 2x10 10 vp, MVA 1x10 7 pfu; Group 3, ChAdOx 2x10 8 vp, MVA 1x10 8 pfu; Group 4, ChAdOx 2x10 9 vp, MVA 1x10 8 pfu; Group 5, ChAdOx 2x10 10 vp, MVA 1x10 8 pfu. 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 adverse events (AEs) and no treatment-related serious AEs. 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. Groups 1, 3, 4 and 5 showed 12%, 11%, 33% and 36%

Forward Looking Statements

Forward Looking Statements This Current Report on Form 8-K contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words "may," "will," "plan," "forward," "encouraging," "believe," "potential," and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding: the Company's product development activities and clinical trials, including timing for readouts of any interim data or next steps for any of our programs, including VTP-200 and the APOLLO trial, the tolerability or potential benefits of VTP-200, and the Company's ability to develop and advance its current and future product candidates and programs. Any forward-looking statements in this Current Report on Form 8-K are based on management's current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this Current Report on Form 8-K, including, without limitation, risks and uncertainties related to the success, cost and timing of the Company's pipeline development activities and planned and ongoing clinical trials, the Company's ability to execute on its strategy, regulatory developments, the Company's ability to fund its operations and access capital, the risk that interim or topline data may not reflect final data or results, global economic uncertainty, including disruptions in the banking industry, the conflict in Ukraine, and the conflict in Israel and Gaza, and other risks identified in the Company's filings with the Securities and Exchange Commission (the "SEC"), including its Annual Report on Form 10-K for the year ended December 31, 2023, its Quarterly Reports on Fo

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits 99.1 Press Release dated April 18 , 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Barinthus Biotherapeutics plc Date: April 18, 2024 By: /s/ William Enright William Enright Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR