Barinthus Biotherapeutics Files 8-K

Ticker: BRNS · Form: 8-K · Filed: Nov 15, 2024 · CIK: 1828185

Barinthus Biotherapeutics PLC. 8-K Filing Summary
FieldDetail
CompanyBarinthus Biotherapeutics PLC. (BRNS)
Form Type8-K
Filed DateNov 15, 2024
Risk Levellow
Pages6
Reading Time8 min
Sentimentneutral

Sentiment: neutral

Topics: filing, financials, corporate-action

TL;DR

Barinthus Biotherapeutics filed an 8-K with financial statements and exhibits.

AI Summary

On November 15, 2024, Barinthus Biotherapeutics plc filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific new financial figures or material events were detailed in the provided excerpt.

Why It Matters

This 8-K filing indicates routine corporate reporting, including financial statements and exhibits, which are important for investors to stay updated on the company's status.

Risk Assessment

Risk Level: low — The filing is a routine 8-K report detailing financial statements and exhibits, with no immediate indication of significant new risks or material adverse events.

Key Players & Entities

  • Barinthus Biotherapeutics plc (company) — Registrant
  • November 15, 2024 (date) — Date of earliest event reported
  • 001-40367 (company) — Commission File Number
  • Vaccitech plc (company) — Former company name
  • 20210407 (date) — Date of name change from Vaccitech plc
  • Vaccitech Ltd (company) — Former company name
  • 20201014 (date) — Date of name change from Vaccitech Ltd

FAQ

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

The primary purpose of this 8-K filing is to report on financial statements and exhibits, as well as other events and a Regulation FD disclosure, as of November 15, 2024.

When was the earliest event reported in this 8-K filing?

The earliest event reported in this 8-K filing was on November 15, 2024.

What was Barinthus Biotherapeutics plc formerly known as?

Barinthus Biotherapeutics plc was formerly known as Vaccitech plc, with a name change effective April 7, 2021, and prior to that, Vaccitech Ltd, with a name change effective October 14, 2020.

What is the Commission File Number for Barinthus Biotherapeutics plc?

The Commission File Number for Barinthus Biotherapeutics plc is 001-40367.

What are the main items disclosed in this 8-K filing?

The main items disclosed in this 8-K filing are Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits.

Filing Stats: 1,891 words · 8 min read · ~6 pages · Grade level 13.6 · Accepted 2024-11-15 11:06:04

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On November 15, 2024, Barinthus Biotherapeutics plc (the "Company") issued a press release titled "Arbutus and Barinthus Bio Announce New Data from the IM-PROVE II Trial Showing that the Addition of Nivolumab Increased Rates of HBsAg Loss 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 November 15, 2024, the Company issued a press release titled "Barinthus Bio Announces Results From Ongoing Phase 2b Chronic Hepatitis B Trial, Including Achievement of Functional Cure and HBsAb Seroconversion" A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K. On November 15, 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 99.3 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, 99.2 and 99.3) 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 November 15, 2024, the Company announced the datasets associated with updated data from the ongoing IM-PROVE II and HBV003 trial presented at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting 2024. New Data from the IM-PROVE II trial The new data are from an additional cohort of participants (Group C) who received repeat doses of imdusiran, Arbutus' RNAi therapeutic, followed by Barinthus Bio's T-cell stimulating immunotherapeutic, VTP-300, with or without low-dose nivolumab, an anti-PD-1 monoclonal antibody. The data indicated that Group C participants receiving nivolumab experienced increased rates of HBsAg loss (defined as HBsAg <LLOQ [0.05 IU/mL]) compared to Group A and B participants who received imdusiran and VTP-300 or placebo. The data from Groups A and B were previously presented at the European Association for the Study of the Liver (EASL) Congress in June 2024. Group C enrolled a total of 22 non-cirrhotic, virally suppressed cHBV participants with HBsAg 100 to <5,000 IU/mL at screening who were on stable nucleos(t)ide analogue (NUC) therapy for 12 months. Thirteen of these participants were eligible to receive low-dose nivolumab and nine participants were not eligible, based on the trial criteria. The preliminary data from Group C included data to Week 48 (20/22 participants) and showed the following: Imdusiran lead-in treatment led to a mean decline from baseline in HBsAg consistent with data from Groups A and B. Significantly greater mean declines in HBsAg levels (p <0.017) were seen in Group C participants, who received imdusiran and VTP-300 with nivolumab, at Week 48 compared with Groups A and B and Group C without nivolumab. 23% of participants (3/13) in the group receiving imdusiran, VTP-300 and low-dose nivolumab achieved HBsAg loss by Week 48. Increases in soluble immune biomarkers associated with immune checkpoint proteins, inflammation, and T-cell activation were obser

Forward Looking Statements

Forward Looking Statements This Current Report on Form 8-K 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, including the combination with nivolumab, and our ability to develop and advance our current and future product candidates and programs. Any forward-looking statements in this Current Report on Form 8-K 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 Current Report on Form 8-K, including, without limitation, risks and uncertainties related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of our clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, our ability to execute on our strategy, regulatory developments, the risk that we may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, our ability to fund our operations and acce

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits 99.1 Press Release dated November 15, 2024. 99.2 Press Release dated November 15, 2024. 99.3 Corporate Deck dated November 15, 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: November 15, 2024 By: /s/ William Enright William Enright Chief Executive Officer

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