Barinthus Biotherapeutics Files 8-K

Ticker: BRNS · Form: 8-K · Filed: Jun 6, 2024 · CIK: 1828185

Barinthus Biotherapeutics PLC. 8-K Filing Summary
FieldDetail
CompanyBarinthus Biotherapeutics PLC. (BRNS)
Form Type8-K
Filed DateJun 6, 2024
Risk Levellow
Pages6
Reading Time7 min
Sentimentneutral

Sentiment: neutral

Topics: 8-K, SEC Filing, Corporate Update

TL;DR

Barinthus Biotherapeutics filed a routine 8-K on 6/6/24, no major news.

AI Summary

On June 6, 2024, Barinthus Biotherapeutics plc. filed an 8-K report. The filing primarily concerns other events and Regulation FD disclosures, with no specific financial figures or new material events detailed in the provided text.

Why It Matters

This filing indicates routine corporate reporting by Barinthus Biotherapeutics plc. to the SEC, without disclosing new material information in the provided excerpt.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report with no indication of significant new risks or material adverse events.

Key Players & Entities

  • Barinthus Biotherapeutics plc. (company) — Registrant
  • Vaccitech plc (company) — Former company name
  • Vaccitech Ltd (company) — Former company name
  • June 6, 2024 (date) — Date of report

FAQ

What is the primary purpose of this 8-K filing for Barinthus Biotherapeutics plc.?

The filing is primarily for Regulation FD Disclosure and Other Events, as well as Financial Statements and Exhibits, according to the report filed on June 6, 2024.

What was Barinthus Biotherapeutics plc.'s former name?

Barinthus Biotherapeutics plc. was formerly known as Vaccitech plc, with a name change date of April 7, 2021.

When was the earliest event reported in this filing?

The earliest event reported in this filing was on June 6, 2024.

What is the company's standard industrial classification?

The company's Standard Industrial Classification is Pharmaceutical Preparations [2834].

Where is Barinthus Biotherapeutics plc. located?

The company's business address is Unit 6-10, Zeus Building, Rutherford Avenue, Harwell, Didcot, OX11 0DF.

Filing Stats: 1,833 words · 7 min read · ~6 pages · Grade level 13.6 · Accepted 2024-06-06 16:02:55

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On June 6, 2024, Barinthus Biotherapeutics plc (the "Company") issued a press release titled "Barinthus Bio's VTP-300 Trials Demonstrate Ability to Achieve Undetectable HBsAg levels and Statistical Significance in Lowering HBsAg Levels in People with Chronic Hepatitis B." A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. On June 6, 2024, the Company updated its corporate presentation for use in meetings with investors, analysts and others. A copy of this presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K. The Company undertakes no obligation to update, supplement or amend the presentation. The information in Item 7.01 of this Current Report on Form 8-K (including Exhibits 99.1 and 99.2) is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

01. Other Events

Item 8.01. Other Events. On June 6, 2024, the Company announced updated data from two clinical trials in people with chronic hepatitis B (CHB) at the European Association for the Study of the Liver (EASL) Congress 2024. The presentations include updated interim data from the Phase 2b clinical trial (HBV003), as well as new interim end of treatment (EOT) data from the Phase 2a clinical trial (IM-PROVE II, AB-729-202) in partnership with Arbutus Biopharma (NASDAQ: ABUS), both in people with CHB receiving ongoing standard of care nucleos(t)ide analogue (NUC) therapy. Interim HBV003 data: VTP-300 and Low-dose Nivolumab Interim data from the HBV003 trial indicate that treatment with VTP-300 and low-dose nivolumab is generally well-tolerated and sustained HBsAg declines were observed across all groups, with some participants reaching undetectable levels of HBsAg. As of the data cutoff on April 15, 2024, 91 out of a planned 120 virally suppressed patients with CHB on stable NUC therapy were enrolled in the trial, 40 of whom had screening HBsAg 200 IU/mL as per the study protocol amendment in 2023 and 21 of whom had been assessed for NUC discontinuation. Participants reaching Day 169 were assessed to confirm if they were eligible to discontinue NUC therapy in line with the study criteria. Data presented focuses on participants with baseline HBsAg 200 IU/mL: 76% of assessed participants (n=16/21) were eligible for NUC discontinuation at EOT, 7 of these discontinued. 71% (n=5/7) remained off NUC therapy, up to 44 weeks post-discontinuation in one case. 19% of participants (n=4/21) across the groups assessed for NUC discontinuation, had undetectable HBsAg at any time. This has been maintained for 16 weeks in 2 cases. 67% of participants (n=14/21) across all groups assessed for NUC discontinuation had HBsAg <10 IU/mL at Week 24 or later. Robust T cell responses as measured by IFN ELISpot were observed to all encoded antigens. There were no Serious Adverse Events (SA

Forward Looking Statements

Forward Looking Statements This press release contains forward-looking statements regarding Barinthus Bio 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 our product development activities and clinical trials, including timing for readouts of any interim data or next steps for any of our programs, including VTP-300 and the HBV003 trial, the timing for readouts for the IM-PROVE II trial of our collaboration partner, Arbutus, the tolerability or potential benefits of VTP-300 or imdusiran, and our ability to develop and advance our current and future product candidates and programs. Any forward-looking statements in this press release are based on our 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 press release, including, without limitation, risks and uncertainties related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, our ability to execute on our strategy, regulatory developments, our ability to fund our 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, the conflict in Israel and Gaza, and other risks identified in our filings with the Securities and Exchange Commission (the "SEC"), including our Annual Report on Form 10-K for the year ended December 31, 2023, ou

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits 99.1 Press Release dated June 6 , 2024. 99.2 Investor Presentation dated June 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: June 6, 2024 By: /s/ William Enright William Enright Chief Executive Officer

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