Barinthus Biotherapeutics plc 8-K, filed Nov 9, 2023
Barinthus Biotherapeutics plc. (BRNS)
About this 8-K
Barinthus Biotherapeutics plc filed this 8-K on November 9, 2023.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trade Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act.
*American Depositary Shares may be evidenced by American Depositary Receipts. Each American Depositary Share represents one (1) ordinary share. Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Global Market. The American Depositary Shares represent the right to receive ordinary shares and are being registered under the Securities Act of 1933, as amended, pursuant to a separate Registration Statement on Form F-6. Accordingly, the American Depositary Shares are exempt from the operation of Section 12(a) of the Securities Exchange Act of 1934, as amended, pursuant to Rule 12a-8.
Item 7.01. Regulation FD Disclosure.
On November 9, 2023, Barinthus Biotherapeutics plc (the Company) issued a press release titled “Barinthus Bio Presents Interim Data from Phase 2b HBV003 Trial and Phase 2a AB-729-202 Trial in Collaboration with Arbutus Biopharma in Chronic HBV Patients at AASLD.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
On November 9, 2023, 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.
Item 8.01. Other Events.
On November 9, 2023, the Company announced data from 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. Alongside this, interim data from patients with chronic hepatitis B (CHB) from the Phase 2a AB-729-202 trial combining Arbutus Biopharma Corporation’s (NASDAQ: ABUS) RNAi therapeutic candidate, imdusiran (AB-729), with the Company’s T-cell stimulating immunotherapeutic candidate, VTP-300, and SoC NUC therapy.
Study HBV003: VTP-300 and Low-dose Nivolumab
HBV003 is designed to obtain critical information on treatment dosing regimen with patients receiving VTP-300 and low-dose nivolumab. All Groups received ChAdOx at Day 1, Groups 1 & 2 received MVA with nivolumab at Day 29 with Group 2 being dosed again at Day 85, Group 3 received only MVA at Day 29, followed by nivolumab at Day 36 and a second MVA dose at Day 85 to evaluate PD-1 inhibition timing. Seventy-four out of a planned 120 virally-suppressed CHB patients on stable NUC therapy have been enrolled in the trial and 57 have reached Day 113. VTP-300 in combination with nivolumab led to HBsAg declines in all treatment groups, particularly in participants with screening HBsAg levels ≤200 IU/mL.
| · | >0.5 and >1 log drops have been observed in all groups at Day 113 in 23% and 9% of participants, respectively. |
| · | Participants with an HBsAg level of ≤200 IU/mL at screening were more likely to have >1 log HBsAg reductions (31%) compared to those with HBsAg levels >200 IU/mL at Day 1 (2%). |
| · | Greater mean HBsAg log reductions were observed in Group 2 (ChAdOx-HBV Day 1; MVA-HBV and nivolumab Day 29 and Day 85) but insufficient data for definitive conclusion. |
| · | Seven participants have met the criteria for NUC discontinuation; three have discontinued and two have restarted NUC therapy. |
| · | Preliminary safety data suggest VTP-300 in combination with nivolumab has been generally well tolerated, with no treatment-related SAEs observed or reported. Thyroid dysfunction reported in 7 participants attributed to nivolumab administration which has returned to normal in 4 patients. |
The HBV003 trial protocol is currently being amended to include only participants with screening HBsAg ≤200 IU/mL. Participants with screening HBsAg ≤200 IU/mL have been observed to benefit the most in the preliminary data, with the trial protocol amendment being focused on improving the overall risk/benefit ratio. People with thyroid auto-antibodies, family history of auto-immune thyroiditis, or abnormal thyroid levels will be excluded from trial eligibility to minimize the risk of thyroiditis.
Study AB-729-202: VTP-300 in Combination with Imdusiran (AB-729)
Clinical trial AB-729-202 enrolled forty non-cirrhotic, virally suppressed CHB patients that were on stable NUC therapy. The patients initially received imdusiran (60mg every 8 weeks) for 24 weeks and were then randomized to receive either VTP-300 or placebo at week 26 and 30 (and conditionally at week 38 if they experienced a >0.5 log10 decline in HBsAg between Weeks 26 and 34), in addition to ongoing NUC therapy. The preliminary data include a subset of patients that received the two dose VTP-300 regimen (28/40 patients) and available follow-up data to Week 48 (12/40 patients) and showed the following:
| · | Robust reductions of HBsAg were seen during the imdusiran treatment period (-1.86 log10 mean reduction from baseline after 24 weeks of treatment). This decline in HBsAg is comparable to the declines seen with imdusiran in other clinical trials conducted to date. |
| · | 97% of the imdusiran treated patients (33/34) had HBsAg <100 IU/mL at the time of the first VTP-300/placebo dose. |
| · | VTP-300 treatment appeared to contribute to the maintenance of low HBsAg levels in the early post-treatment period, as the mean HBsAg levels in the placebo group begin to increase starting approximately 12 weeks after the last dose of imdusiran. |
| · | All VTP-300 treated patients have maintained HBsAg <100 IU/mL through week 48, 60% have maintained HBsAg <10 IU/mL, and all have qualified to stop NUC therapy. |
| · | Preliminary immunology data suggests HBV-specific T cell IFN-γ production was enhanced in patients receiving imdusiran plus VTP-300 compared to placebo. |
The preliminary safety data from this trial demonstrated that imdusiran and VTP-300 were both generally well-tolerated. There were no serious adverse events, Grade 3 or 4 adverse events, or treatment discontinuations.
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 plans and strategy with respect to its pipeline and product candidates, including VTP-300 and the HBV003 clinical trial, and the potential benefits of VTP-300 for the treatment of chronic HBV. 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 risk that the Company may not realize the benefits related to its rebranding and name change, the Company’s ability to fund its operations and access capital, 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, 2022, its Quarterly Reports on Form 10-Q and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| 99.1 | Press Release dated November 9, 2023. |
| 99.2 | Investor Presentation dated November 2023 |
| 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 9, 2023 | By: | /s/ William Enright |
| William Enright | ||
| Chief Executive Officer | ||
Exhibit 99.1
Barinthus Bio Presents Interim Data from Phase 2b HBV003 Trial and Phase 2a AB-729-202 Trial in Collaboration with Arbutus Biopharma in Chronic HBV Patients at AASLD
| · | Initial data from the combination of imdusiran and VTP-300 show meaningful reductions of HBsAg levels that were maintained well below baseline. |
| · | In HBV003, 31% of participants with screening HBsAg level of ≤200 IU/mL had >1 log HBsAg reductions. |
| · | VTP-300 was generally well-tolerated in both trials. |
OXFORD, United Kingdom, Nov. 9, 2023 (GLOBE NEWSWIRE) – Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today announced the presentation of data from two HBV clinical trials at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023. The presentations include an oral presentation of data from 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. Alongside this, a late-breaking poster presentation with interim data from patients with chronic hepatitis B (CHB) from the Phase 2a AB-729-202 trial combining Arbutus Biopharma Corporation’s (NASDAQ: ABUS) RNAi therapeutic candidate, imdusiran (AB-729), with Barinthus Bio’s T-cell stimulating immunotherapeutic candidate, VTP-300, and SoC NUC therapy. Barinthus Bio 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.
“We believe these early data are very encouraging. In HBV003, VTP-300 in combination with nivolumab continues to show meaningful and sustained HBsAg declines across all treatment groups, with the most prominent declines occurring in patients with lower baseline HBsAg levels at screening,” said Bill Enright, Chief Executive Officer of Barinthus Bio. Regarding the combination trial imdusiran with VTP300, Bill added “Although these are preliminary data, we can already see that VTP-300 appears to show a meaningful impact in sustaining low HBsAg in patients after imdusiran treatment, with clear differences shown between placebo and VTP-300. It’s very positive that we are seeing that all participants treated with imdusiran and VTP-300 have qualified to stop NUC therapy, which really highlights VTP-300’s potential as an important component of a functional cure regimen.”
Study HBV003: VTP-300 and Low-dose Nivolumab
HBV003 is designed to obtain critical information on treatment dosing regimen with patients receiving VTP-300 and low-dose nivolumab. All Groups received ChAdOx at Day 1, Groups 1 & 2 received MVA with nivolumab at Day 29 with Group 2 being dosed again at Day 85, Group 3 received only MVA at Day 29, followed by nivolumab at Day 36 and a second MVA dose at Day 85 to evaluate PD-1 inhibition timing. Seventy-four out of a planned 120 virally-suppressed CHB patients on stable NUC therapy have been enrolled in the trial and 57 have reached Day 113. VTP-300 in combination with nivolumab led to HBsAg declines in all treatment groups, particularly in participants with screening HBsAg levels ≤200 IU/mL.
| · | >0.5 and >1 log drops have been observed in all groups at Day 113 in 23% and 9% of participants, respectively. |
| · | Participants with an HBsAg level of ≤200 IU/mL at screening were more likely to have >1 log HBsAg reductions (31%) compared to those with HBsAg levels >200 IU/mL at Day 1 (2%). |
| · | Greater mean HBsAg log reductions were observed in Group 2 (ChAdOx-HBV Day 1; MVA-HBV and nivolumab Day 29 and Day 85) but insufficient data for definitive conclusion. |
| · | Seven participants have met the criteria for NUC discontinuation; three have discontinued and two have restarted NUC therapy. |
| · | Preliminary safety data suggest VTP-300 in combination with nivolumab has been generally well tolerated, with no treatment-related SAEs observed or reported. Thyroid dysfunction reported in 7 participants attributed to nivolumab administration which has returned to normal in 4 patients. |
The HBV003 trial protocol is currently being amended to include only participants with screening HBsAg ≤200 IU/mL. Participants with screening HBsAg ≤200 IU/mL have been observed to benefit the most in the preliminary data, with the trial protocol amendment being focused on improving the overall risk/benefit ratio. People with thyroid auto-antibodies, family history of auto-immune thyroiditis, or abnormal thyroid levels will be excluded from trial eligibility to minimize the risk of thyroiditis.
Study AB-729-202: VTP-300 in Combination with Imdusiran (AB-729)
Clinical trial AB-729-202 enrolled forty non-cirrhotic, virally suppressed CHB patients that were on stable NUC therapy. The patients initially received imdusiran (60mg every 8 weeks) for 24 weeks and were then randomized to receive either VTP-300 or placebo at week 26 and 30 (and conditionally at week 38 if they experienced a >0.5 log10 decline in HBsAg between Weeks 26 and 34), in addition to ongoing NUC therapy. The preliminary data include a subset of patients that received the two dose VTP-300 regimen (28/40 patients) and available follow-up data to Week 48 (12/40 patients) and showed the following:
| · | Robust reductions of HBsAg were seen during the imdusiran treatment period (-1.86 log10 mean reduction from baseline after 24 weeks of treatment). This decline in HBsAg is comparable to the declines seen with imdusiran in other clinical trials conducted to date. |
| · | 97% of the imdusiran treated patients (33/34) had HBsAg <100 IU/mL at the time of the first VTP-300/placebo dose. |
| · | VTP-300 treatment appeared to contribute to the maintenance of low HBsAg levels in the early post-treatment period, as the mean HBsAg levels in the placebo group begin to increase starting approximately 12 weeks after the last dose of imdusiran. |
| · | All VTP-300 treated patients have maintained HBsAg <100 IU/mL through week 48, 60% have maintained HBsAg <10 IU/mL, and all have qualified to stop NUC therapy. |
| · | Preliminary immunology data suggests HBV-specific T cell IFN-γ production was enhanced in patients receiving imdusiran plus VTP-300 compared to placebo. |
The preliminary safety data from this trial demonstrated that imdusiran and VTP-300 were both generally well-tolerated. There were no serious adverse events, Grade 3 or 4 adverse events or treatment discontinuations.
Dr. Karen Sims, Chief Medical Officer of Arbutus Biopharma, commented, “Imdusiran consistently delivers compelling efficacy and safety data in multiple Phase 2a populations and combinations. In this trial, all but one patient reached surface antigen levels below 100 IU/mL and one reached <LLOQ (lower limit of quantification) with 24 weeks of imdusiran plus NUC therapy alone, which is a meaningful achievement as we believe lowering surface antigen is key to promoting host HBV-specific immune reawakening. As we continue to dose and follow these patients, I look forward to seeing the potential that imdusiran, VTP-300 and NUC therapy can have on achieving a functional cure for patients with CHB.”
The presentation for HBV003 and poster for AB-729-202 can be found on the Barinthus Bio website at https://investors.barinthusbio.com/events-presentations.
About Barinthus Bio’s VTP-300
VTP-300 is an immunotherapeutic candidate consisting of an initial dose using the ChAdOx vector and a secondary dose(s) using the MVA vector, both encoding multiple hepatitis B antigens, including full-length surface, modified polymerase and core antigens. VTP-300 is the first antigen-specific immunotherapy that has been shown to induce sustained reductions in HBsAg. Barinthus Bio is studying VTP-300 in combination with other agents, including siRNA and low-dose anti-PD-1 antibodies, to control the infection and counterbalance the immune suppression and T cell exhaustion in the liver caused by chronic HBV infection.
About imdusiran (AB-729), Arbutus’ Lead RNAi Therapeutic
Imdusiran is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data generated thus far has shown single and multiple doses of imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. Imdusiran is currently in multiple Phase 2a clinical trials.
About Hepatitis B Virus (HBV)
Globally it is estimated that there are more than 300 million people, including up to 2.4 million in the U.S. and 14 million in Europe, living with chronic HBV infection, with the highest prevalence in East Asia and Africa. Approximately 820,000 people die each year from HBV and related complications, such as liver cirrhosis and hepatocellular carcinoma. Due to low HBV diagnosis rates of about 10.5% aware of their infection coupled with strict treatment eligibility guidelines, only 6.6 million (2.2%) people with chronic HBV are receiving treatment and less than 10% will achieve a functional cure with existing therapies.
About Barinthus Bio
Barinthus Bio 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. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a broad pipeline, built around four proprietary platform technologies: ChAdOx, MVA, SNAP-TI, and SNAP-CI; Barinthus Bio is advancing a pipeline of five product candidates across a diverse range of therapeutic areas, including: VTP-300, an immunotherapeutic candidate designed as a potential component of a functional cure for chronic HBV infection; VTP-200, a non-surgical product candidate for persistent high-risk human papillomavirus (HPV); VTP-1000, an autoimmune candidate designed to utilize the SNAP-TI platform to treat patients with celiac disease; VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer; and VTP-1100, a preclinical cancer candidate designed to utilize the SNAP-CI platform to treat patients with HPV-related cancer. Barinthus Bio’s proven scientific expertise, diverse portfolio and focus on pipeline development uniquely positions the company to navigate towards delivering treatments for people with infectious diseases, autoimmunity and cancers that have a significant impact on their everyday lives. For more information, visit www.barinthusbio.com.
About Arbutus
Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to identify and develop novel therapeutics with distinct mechanisms of action, which can be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). Arbutus believes the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Arbutus’ pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. Additionally, Arbutus has identified compounds in its internal PD-L1 portfolio that could also be used in oncology indications. For more information, visit www.arbutusbio.com.
Barinthus Bio’s 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: Barinthus Bio’s plans and strategy with respect to its pipeline and product candidates, including VTP-300 and the HBV003 clinical trial, and the potential benefits of VTP-300 for the treatment of chronic HBV. Any forward-looking statements in this press release are based on Barinthus Bio 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 Barinthus Bio’s pipeline development activities and planned and ongoing clinical trials, Barinthus Bio’s ability to execute on its strategy, regulatory developments, the risk that Barinthus Bio may not realize the benefits related to its rebranding and name change, Barinthus Bio’s ability to fund its operations and access capital, 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 Barinthus Bio’s filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2022, its Quarterly Reports on Form 10-Q and subsequent filings with the SEC. Barinthus Bio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Barinthus Bio expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Arbutus’ Forward-Looking Statements
This press release contains forward-looking statements regarding Arbutus within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include statements about Arbutus’ belief that the key to success in developing a functional cure for CHB involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses; Arbutus’ future development plans for Arbutus’ product candidates; Arbutus’ program updates; the expected cost, timing and results of Arbutus’ clinical development plans and clinical trials with respect to Arbutus’ product candidates; Arbutus’ expectations with respect to clinical trial design and the release of data from Arbutus’ clinical trials and the expected timing thereof; Arbutus’ expectations and goals for Arbutus’ collaborations with third parties and any potential benefits related thereto, including with respect to the Phase 2a clinical trial combining imdusiran with VTP-300; and the potential for Arbutus’ product candidates to achieve success in clinical trials.
With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing patent litigation matters.
Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the risk that anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; uncertainties associated with litigation generally and patent litigation specifically; Arbutus and its collaborators may never realize the expected benefits of the collaborations, including with Barinthus Bio; and market shifts may require a change in strategic focus; and risks related to the sufficiency of Arbutus’ cash resources and its ability to obtain adequate financing in the future for its foreseeable and unforeseeable operating expenses and capital expenditures.
A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein with respect to Arbutus are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein with respect to Arbutus to reflect future results, events or developments, except as required by law.
Barinthus Bio - Contacts:
Investor Contacts:
Christopher M. Calabrese
Managing Director
LifeSci Advisors
+1 917-680-5608
ccalabrese@lifesciadvisors.com
Kevin Gardner
Managing Director
LifeSci Advisors
+1 617-283-2856
kgardner@lifesciadvisors.com
Media contact:
Audra Friis
Sam Brown, Inc.
+1 917-519-9577
audrafriis@sambrown.com
Company contact:
Jonothan Blackbourn
IR & PR Manager
Barinthus Biotherapeutics
ir@barinthusbio.com
Arbutus - Investors and Media
Lisa M. Caperelli
Vice President, Investor Relations
Phone: 215-206-1822
Email: lcaperelli@arbutusbio.com
Exhibit 99.2
Barinthus Biotherapeutics Corporate Presentation Guiding the Immune System to Cure Disease November 2023
2 This presentation includes express and implied “forward - looking statements,” including forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 . Forward looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as “may,” “will,” “could,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “potential,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future . Forward - looking statements contained in this presentation include, but are not limited to, statements regarding : our product development activities and clinical trials, including timing for readouts of any interim data for any of our programs, our regulatory filings and approvals, our estimated cash runway and cash burn, our ability to develop and advance our current and future product candidates and programs, our ability to establish and maintain collaborations or strategic relationships or obtain additional funding, the rate and degree of market acceptance and clinical utility of our product candidates, and the ability and willingness of our third - party collaborators to continue research and development activities relating to our product candidates . By their nature, these statements are subject to numerous risks and uncertainties, including factors beyond our control, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements . Such risks and uncertainties, include, without limitation, risks and uncertainties related to : preclinical and clinical studies, the success, cost and timing of our product development activities and planned and ongoing preclinical studies and clinical trials, whether results from preclinical studies and clinical trials will be predictive of the results of future trials, our ability to execute on our strategy, regulatory developments, our ability to fund our operations, global economic uncertainty, including disruptions in the banking industry, and the impact that the COVID - 19 pandemic may have on our clinical trials, preclinical studies and access to capital, and other risks, uncertainties and other factors 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 , 2022 , our Quarterly Report on Form 10 - Q for the most recently ended fiscal quarter and subsequent filings with the SEC . You should not rely upon forward - looking statements as predictions of future events . Although our management believes that the expectations reflected in our statements are reasonable, we cannot guarantee that the future results, performance or events and circumstances described in the forward - looking statements will be achieved or occur and actual results may vary . Recipients are cautioned not to place undue reliance on these forward - looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact . Except as required by law, we do not assume any intent to update any forward - looking statements after the date on which the statement is made, whether as a result of new information, future events or circumstances or otherwise . Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third - party sources and our own internal estimates and research . While we believe these third - party studies, publications, surveys and other data to be reliable as of the date of this presentation, it has not independently verified, and makes no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third - party sources . In addition, no independent source has evaluated the reasonableness or accuracy of our internal estimates or research and no reliance should be made on any information or statements made in this presentation relating to or based on such internal estimates and research .
Company Overview • Formerly known as Vaccitech, a spinout company from the Jenner Institute for vaccine research at University of Oxford. • Backed by leading investment institutions with a validated platform from commercialization of one pipeline asset. • Headquartered in the UK with office and research facilities in the US. Our Mission To advance the next generation of immunotherapies that lead T cells to gain control over disease and improve patients’ lives. NASDAQ BRNS Staff 130 (UK: ~70%, US: ~30%) 1 Ordinary Shares Outstanding 38,546,594 2 Cash $160.3M 3 3 Guiding the immune system to cure disease 1 As of November 1, 2023 2 As of September 30, 2023 3 As of September 30, 2023
Compelling Fundamentals Driving Near and Long - term Growth 4 Large market opportunity across portfolio Diverse pipeline with anticipated near - term clinical milestones Proprietary platforms accumulating clinical data • Our proprietary platforms (ChAdOx, MVA, SNAP - CI) are designed to drive powerful immune responses . • We have generated clinical data across multiple indications (HBV, HPV, Prostate Cancer, COVID - 19). • 5 programs across infectious diseases, autoimmunity and cancer, with an additional 4 partnered programs . • 5 clinical stage programs with multiple expected near - term data readouts from 3 Phase 2 programs and 2 Phase 1 programs. • New SNAP - TI platform approaching entry into clinic, backed by strong supportive pre - clinical data. • High unmet need in autoimmune space, with no approved treatment for diseases such as Celiac disease. Expanding into autoimmunity with targeted immunotherapies
Proprietary Platforms and Approach 5 Working to Create More Effective Antigen - Specific Immunotherapies Through Innovative Technologies 1 Swadling et al (2014) Transl Med. 2 Ewer et al (2017) NEJM. 3 Moyo et al (2017) PloS One. 4 Voysey et al (2023 ) Clin. Exp. Immunol. ; Ewer et al (2016) NEJM ; Ogwang et al (2015) Sci Transl Med ; Ogwang et al (2013) PloS One ; Elias et al (2013) J Immunol ; O’Hara et al (2012) J Infect Dis ; Ewer et al (2016) Curr Opin Immunol. 5 Esposito et al (2020) Sci Transl Med . SFC: Spot Forming Colonies. PBMC: Peripheral blood mononuclear cells. Proprietary Viral Platforms Proprietary Synthetic Platform ChAdOx /MVA differentiators SNAP differentiators ChAdOx: Modified, replication - incompetent simian adenoviral vector MVA: Well - studied, replication - deficient, attenuated Vaccinia virus Ideally suited for chronic infections and cancer. Induced the highest published magnitude of disease - specific T cells 1 - 4 Elicit high magnitude, durable and polyfunctional CD8+ and CD4+ T cell responses. 1 - 4 • Two platform versions: SNAP - TI and SNAP - CI specifically designed for autoimmune and cancer indications , respectively. • M odular design utilizing self - assembly to co - deliver multiple antigens and immunomodulators . • C an be combined with ChAdOx and/or MVA in sequential combination regimens . • I deally suited for inducing specific T cell populations needed for diverse therapeutic indications, from oncology to immune tolerance. SNAP S elf - assembled platform co - delivering multiple antigens and immunomodulators 20 nm Antigen Immunomodulator + H 2 0 Self Assembly
6 Product Candidate Program Preclinical Phase 1 Phase 2 Phase 3 Marketed Barinthus Bio Rights Status/Anticipated Upcoming Milestones Infectious Disease Programs VTP - 300 Hepatitis B Virus (HBV) therapeutic Worldwide Phase 2 efficacy data updates (Q4 2023) VTP - 200 Human Papillomavirus (HPV) therapeutic Worldwide Phase 1b/2 final data (Q2 2024) Autoimmune Programs VTP - 1000 Celiac disease Worldwide Regulatory submission to initiate clinical trial (H2 2023) Cancer Programs VTP - 800/850 Prostate cancer therapeutic Worldwide Phase 1/2 futility data ( 2024) VTP - 1100 HPV Cancer Worldwide IND filing (2024) Near - term proof - of - concept readout Existing human clinical data Data supporting proof - of - concept announced ChAdOx + MVA SNAP “ MVA or ChAdOx Pipeline Harnessing the Power of Antigen - Specific Immunotherapies to Treat Infectious Diseases, Autoimmunity and Cancer These are estimated timelines only and our pipeline may be subject to change
VTP - 300 Hepatitis B Virus (HBV) Therapeutic
HBV: Global, Long - term Need for a Functional Cure 8 ~30 0 MILLION patients are chronically infected with HBV 1 1.5 MILLION new infections per year 1 Less than 10% get to Functional Cure with existing therapies 2 ~0.8 MILLION deaths per year from acute HBV infection, cancer & cirrhosis 1 ~25% of cases of chronic HBV infection progress to liver cancer 4 There is an urgent need to develop effective therapeutic strategies to cure chronic HBV infection 1 WHO, Hepatitis B , 2022 2 Boyd A, et al, Viruses. 2021 Jul 11;13(7):1341 3 Hsu YC, et al, Nat Rev Gastroenterol Hepatol. 2023 Aug;20(8):524 - 37 4 US CDC, Global Immunization, July 2022 5 Broquetas T and Carrion JA, Hepat Med. 2002 Jul;14:87 - 100 6 Van Zonneveld M, et al, Aliment Pharmacol Ther . 2005 May 1;21(9):1163 - 71 Existing therapies typically require chronic treatment NUCs are slow - acting with low cure efficacy 5 Pegylated Interferon has significant side effects 6 There is significant unmet medical need Large market opportunity for VTP - 300 ~300M Adults chronically infected with HBV 1 ~52M - only 15 - 20% diagnosed 7 7 Barinthus Bio, Data on file NUCs = Nucleos (t)ide analogs Projected increase in annual global deaths from HBV from 2015 - 30 with status quo 3 ~39%
VTP - 300 is an antigen - specific investigational immunotherapy that could be a critical component to enhancing rates of a functional cure. It is likely that a functional cure will require a combination of agents with complementary mechanisms of ac tio n. VTP - 300 Could be Critical Component to a Functional Cure Regimen for HBV 9 Inhibit viral replication Directly lower viral antigen Hepatitis B surface antigen burden (HBsAg) Stimulate host immune system response Approved Investigational Investigational NUCs Capsid & Entry Inhibitors ( Investigational ) RNAi Oligonucleotide Monoclonal antibodies ( mAbs ) Ag - specific immunotherapies PD - 1 Inhibitors Immunostimulants (TLR agonists) VTP - 300 is designed to engage the host immune system and has been shown to induce sustained HBsAg reduction. The objective of ongoing and planned clinical trials is to evaluate VTP - 300 in combination with other therapies as a component of a functional cure : NUCs + VTP - 300 + anti - PD - 1 NUCs + RNAi + VTP - 300 NUCs + VTP - 300 NUCs + RNAi + VTP - 300 + anti - PD - 1 Three potential components to a functional cure
10 HBV002 – VTP300 Ph 1b/2a; Trial Complete HBV DNA <40 copies HBsAg <4,000 IU/mL On NUCs for 1 year Inclusion Criteria Primary Endpoints VTP - 300 + Low - Dose Nivolumab (N=55) Secondary Endpoints • Safety: incidence of AEs and SAEs • % participants with reduction in HBsAg titre • % participants with HBsAg Loss • % participants with reduction of HBV DNA • Magnitude and avidity of HBV - specific CD4+ and magnitude of HBV - specific CD8+ T cells induced by each treatment regimen Objective: Evaluating safety, tolerability and T cell activity Group 1 (N= 10 ) Group 2 (N=18) Group 3 (N=18) Group 4 (N=9) MVA - HBV ChAdOx - HBV ChAdOx - HBV ChAdOx - HBV + LD Nivo * Day 1 Day 29 MVA - HBV MVA - HBV MVA - HBV + LD Nivo MVA - HBV + LD Nivo * Randomization N=55 Study reference: NCT04778904 *Nivolumab used with Day 1 and Day 29 doses in Group 4 CONFIDENTIAL
1 Full data was presented as a poster at EASL, Q2 2023. • VTP - 300 was administered with no treatment - related SAEs , and infrequent transient transaminitis. • Significant and durable reductions of HBsAg were seen in both VTP - 300 monotherapy (Group 2) and VTP - 300 + low - dose nivolumab group (Group 3) • Reductions in HBsAg were most prominent in those with lower baseline HBsAg . • Non - detectable HBsAg was observed in 2 of 5 Group 3 patients with baseline HBsAg <100 IU/mL at month 3 through month 9 . • Robust T cell response against all encoded antigens was observed following VTP - 300 administration. • VTP - 300 led to a decline in HBsAg in both genotype B and C patients 11 Maximum observed drop in HBsAg 0.3 logs or less 0.3 to <0.5 logs 0.5 to <1.0 logs 1.0 log or higher Dosing 1 HBV002 - VTP - 300 Showed Meaningful, Sustained HBsAg Reductions 1 1
HBV DNA ≤20 IU/mL HBsAg ≥100 to <5,000 IU/mL On NUCs for 1 year Inclusion Criteria Primary Endpoints Secondary Endpoints Safety: incidence of AEs and SAEs • Change in HBsAg concentration from baseline • Proportion of participants with a change in HBsAg from baseline meeting response criteria (≥0.5, 1, 2, or 3 log10 reduction) • Change in HBV DNA, RNA, core - related antigen, HBsAg antibody, HBsAg e - antibody from baseline AB - 729 (RNAi) + VTP - 300 +/ - Low - dose Nivolumab (N=60) Trial expanded in Q4 2022 to include an arm with low - dose Nivolumab 12 * Additional MVA - HBV/ Placebo to be dosed at Week 38, if patients have experienced a ≥0.5 log drop in HBsAg from Week 26 to Week 34. ** Additional MVA - HBV + Nivo to be dosed at Week 38, if patients have HBsAg ≥10 IU/mL at Week 34. LD: Low - dose AB - 729 (N=60) Week 1 Group A (N= 2 0 ) Group B (N=20) Week 24 Week 26 Week 48 ChAdOx - HBV Placebo Group C (N=20) ChAdOx - HBV Week 30 MVA - HBV + LD Nivo ** MVA - HBV* Placebo* Patients to discontinue NUCs if eligible Randomization Open Group • Alanine amino transferase (ALT) <2 î Upper limit of normal (ULN), and • HBV DNA <Lower limit of quantification (LLOQ), and • Hepatitis B e Antigen ( HBeAg ) negative, and • HBsAg <100 IU/mL, and/or • HBsAb positive Criteria: AB - 729 - 202 – Ph2a clinical collaboration with Arbutus; study design
AB - 729 - 202 Ph 2a – Interim Data 1 13 Meaningful and Sustained Declines Shown in HBsAg Levels with Imdusiran and VTP - 300 1 Based on interim data analysis presented as a poster by Arbutus Biopharma at AASLD, Q4 2023. Mean HBsAg Change from Baseline and Key Milestones Mean HBsAg Change from Baseline by Treatment Group Preliminary results: • Robust reductions of HBsAg were observed during the imdusiran treatment period, with 33/34 (97%) of subjects <100 IU/mL at the time of VTP - 300/placebo administration. • VTP - 300 treatment appeared to contribute to maintaining low HBsAg levels in the early post - treatment period . • All subjects who have reached Week 48 in Group A (N=5) have qualified to stop NUC therapy and remain off - treatment. *3 subjects have not yet reached VTP - 300 dosing period and are excluded from plot SE = standard error; N = subject number; Week 26 = ChAdOx1 - HBV/placebo dose; Week 34 = Eligibility assessed for 2ndMVA - HBV/placebo dose (>0.5 log 10 decline in HBsAg between Week 26 and 34).
AB - 729 - 202 Ph 2a – Interim Data 1 14 HBV - Specific T Cell Responses and Soluble Immune Biomarkers Increased after VTP - 300 dosing Preliminary results: • Elevations in HBV - specific T cell IFN - γ production were observed during imdusiran lead - in and after Week 26 dosing for N=7 subjects profiled thus far. • HBV - specific T cell IFN - γ production was enhanced in subjects receiving VTP - 300 (N=4) vs placebo (N=3). • HBV - specific T cell responses were observed against HBsAg, PreS1/S2 peptides in VTP - 300 treated subjects (N=4). • Transient increases in other plasma immune biomarkers were also observed during imdusiran lead - in and VTP - 300/placebo dosing period. • Subject 30 (Group A/VTP - 300) experienced HBsAg decline and enhanced IFN - γ production (via ELISpot) after VTP - 300 through Week 48 1 Based on interim data analysis presented as a poster by Arbutus Biopharma at AASLD, Q4 2023.
HBV003 – Ph 2b Study Enrolling Patients Inclusion Criteria HBV DNA ≤1,000 IU/mL HBsAg ≥10 to <4,000 IU/mL On NUCs for ≥6 months Primary Endpoint % participants with a greater than 1 log HBsAg reduction at 6 months after initiation of therapy Secondary Endpoints • Safety: incidence of AEs and SAEs • T cell response HBV003 is designed to obtain critical information on treatment dosing regimen • Group 1: Mirrors Group 3 in HBV002 to further support response effect observed • Group 2: Assesses if additional dose of MVA - HBV with LD nivolumab at Day 85 further reduces HBsAg • Group 3: Assesses if delaying LD nivolumab until after MVA - HBV is more optimal (plus adds option of 2nd MVA - HBV dose) VTP - 300 + Low - Dose Nivolumab (N=120) - Initiated in Q4 2022 Objective: Evaluating Additional Dosing and PD - 1 Inhibition Timing MVA - HBV + LD Nivo Day 1 Group 1 (N= 40) Group 2 (N=40) Group 3 (N=40) ChAdOx - HBV Day 29 Day 36 Day 85 ChAdOx - HBV ChAdOx - HBV MVA - HBV + LD Nivo MVA - HBV MVA - HBV + LD Nivo LD Nivo MVA - HBV Day 169 Patients to discontinue NUCs if eligible • ALT <2 î ULN, and • HBV DNA < LLOQ, and • HBeAg negative, and • HBsAg undetectable, and/or • HBsAg <100 IU/mL Criteria: 15 Study Reference: NCT05343481
VTP - 300 in Combination with Nivolumab Continues to Show Sustained HBsAg Reductions 16 HBV003 Ph 2b – Preliminary Data 1 HBsAg Screening >200 IU/mL** 1 1 1 6WXG\'D\ 0HDQ 6( ORJFKDQJHIURP'D\ HBsAg Screening ≤200 IU/mL** 1 1 1 6WXG\'D\ 0HDQ 6( ORJFKDQJHIURP'D\ Day 113: 4 weeks after last MVA dose Day 169: NUC discontinuation data • VTP - 300 in combination with nivolumab was observed to lead to HBsAg declines in all treatment groups , with reductions in HBsAg most prominent in patients with screening HBsAg levels ≤200 IU/mL *. • >0.5 and >1 log drops were observed in all groups at Day 113 in 23% and 9% of participants. • Participants with an HBsAg level of <200 IU/mL at Day 1 were more likely to have >1 log HBsAg reductions (31%) vs those with HBsAg levels > 200 IU/mL at Day 1 (2%). • Protocol being amended to include only participants with screening HBsAg ≤ 200 IU/ mL. *Participants with screening HBsAg <200 IU/mL account for ~30% of those currently on the study. **All Participants received ChAdOx - HBV on Day 1 1 Preliminary data presented as an oral presentation at AASLD, Q4 2023. • Group 1: Day 1 ChAdOx1 - HBV, Day 29 MVA - HBV+Nivo • Group 2: Day 1 ChAdOx1 - HBV, Day 29 & Day 85 MVA - HBV+Nivo • Group 3: Day 1 ChAdOx1 - HBV, Day 29 MVA - HBV, Day 36 Nivo , Day 85 MVA - HBV
17 All Participants by Screening HBsAg level <200 IU/mL vs >200 IU/mL • Preliminary data demonstrated that: • 54% participants with HBsAg at Screening ≤ 200 IU/mL had a >0.5 log decline from Day 1 * • 31% of participants with HBsAg at Screening ≤ 200 IU/mL had a >1 log decline from Day 1 * HBV003 Ph 2b – Preliminary Data 1 *Of subset of participants with data available at day 113. * * Discontinuation criteria: ALT <2 î ULN, and HBV DNA < LLOQ, and HBeAg negative, and HBsAg undetectable, and/or HBsAg <100 IU/ mL. NUC discontinuation** by Day 169 • Participants who discontinued NUCs closely followed up post - discontinuation o Bi - weekly for 8 weeks; monthly for 4 months; and quarterly for 6 months o Strict criteria for reinitiating NUCs • 7 (15%) of 47 participants who reached Day 169 were eligible for discontinuation* o 7 (78%) of 9 participants who reached Day 169 with screening HBsAg below 200 IU/mL were eligible o 3 participants have discontinued NUC therapy Safety Data • Preliminary safety data suggest VTP - 300 + nivolumab was generally well tolerated with no treatment related SAEs . • Transient ALT/AST elevations and thyroid function abnormalities observed in all groups 1 Preliminary data presented as an oral presentation at AASLD, Q4 2023.
VTP - 200 Human Papillomavirus (HPV) Therapeutic
Persistent HPV Infection Remains a Significant Public Health Problem 1 19 We are targeting persistent HPV – which can lead to precancerous lesions and cervical cancer 1 HPV is the most common sexually transmitted viral infection in the world 1 Cervical cancer was the 4 th most common cancer in women globally in 2020 2 . >95% of cervical cancer is caused by HPV 2 Approximately 291 million women worldwide are infected with HPV 4 • While HPV prophylactic vaccines are effective at preventing infection, these vaccines do not eliminate existing infections . 1 • L ow vaccination rates in many regions of the world. 1 • >3.6M diagnosed persistent high - risk cervical HPV in US and across 5EU annually collectively. 6 • Standard of care is monitoring and excision once high - grade lesions develop. 1 • Currently no treatment before high - grade lesions develop. 1 • People with HPV infections report cancer - related fear , worry over lack of treatment and HPV being a ‘ticking time bomb’ . 5 There is a high unmet need for patients with persistent HPV infection Cervical cancer in the US 3 : ~4,000 deaths per year even with screening & treatment ~12,000 cases per year ~342,000 deaths per year ~ 604 ,000 cases per year Cervical cancer worldwide 2 : 1 WHO, HPV vaccines: WHO position paper, 2022 2 WHO, Cervical Cancer 3 Center for Disease Control 4 Lancet Infect Dis. 2007 Jul;7(7):453 - 9. 10.1016/S1473 - 3099(07)70158 - 5 5 Psychooncology . 2021 Jan; 30(1 ): 84 – 92. doi : 10.1002/pon.5540 6 Barinthus Bio, Data on File
APOLLO (HPV001) – Ph 1b/2 Study Design 20 Inclusion Criteria High risk HPV positive for >6 months and low - grade cervical lesions. Study outputs Efficacy Data: % clearance of high - risk HPV and cervical lesions evaluated at 12 months. Interim data analysis: Interim data showed VTP - 200 was generally well tolerated with no product - related serious adverse events (SAEs) and had encouraging initial T cell activity results. The trial will continue as planned to the 12 - month primary endpoint. Final data analysis: Expected Q2 2024. Lead - in Phase: (N=9) Objective: Evaluating immunogenicity, safety data Group A (N=3) ChAdOx - HPV 2 x 10 8 vp MVA - HPV 1 x 10 7 pfu Group B (N=3) ChAdOx - HPV 2 x 10 9 vp MVA - HPV 1 x 1 0 7 pfu Group C (N=3) ChAdOx - HPV 2 x 10 10 vp MVA - HPV 1 x 10 8 pfu Regions EU UK Main Phase 1 : VTP - 200 (N=99) – Fully Enrolled Objective: Evaluating safety data, efficacy data, immunogenicity, dose - response 1, N=16 2, N=16 3, N=8 4, N=8 5, N=16 6, N=32 ChAdOx - HPV 2 x 10 9 vp MVA - HPV 1 x 10 7 pfu Day 1 ChAdOx - HPV 2 x 10 10 vp ChAdOx - HPV 2 x 10 8 vp ChAdOx - HPV 2 x 10 9 vp ChAdOx - HPV 2 x 10 10 vp Placebo MVA - HPV 1 x 10 7 pfu MVA - HPV 1 x 10 8 pfu MVA - HPV 1 x 10 8 pfu MVA - HPV 1 x 10 8 pfu Placebo Day 29 Group 60 of the Main phase participants will also take part in an immunogenicity sub - study 1 All groups open simultaneously Study Reference: NCT04607850 Primary Endpoint • Safety: incidence of AEs and SAEs Secondary Endpoints • Efficacy • Dose determination for further studies
21 VTP - 200 Demonstrated Favorable Tolerability and T Cell Profile at Interim Analysis Placebo Arm Active Arms (Pooled) 1 Data from 58 patients who had reached at l east the 6 - month time point, immunogenicity results available from a subset of participants who entered the immunogenicity sub - s tudy (N=45). Interim data presented at the International Papillomavirus Conference. Full data expected to be reported in Q2 2024. • VTP - 200 was generally well - tolerated. N o product - related grade 3 unsolicited adverse events, and no product - related SAEs. • Pooled active groups analysis showed: • Robust IFN γ responses, with average of >1,000 spot - forming units/10 6 . • Strongest T cell responses were observed against the E1, E2 and E6 antigens. • Induction of both CD4 and CD8 T cell responses. • Interim data were presented at IPVC in April 2023. APOLLO (HPV001): Phase 1b/2 Interim Data 1
Autoimmune Program
23 SNAP - TI (Tolerance Immunotherapy) Platform Inducing antigen - specific tolerance to address autoimmune diseases SNAP - TI Given IM Treated Established EAE Disease in Mice 2 Opportunity: Autoimmune diseases are currently treated with therapies that induce broad immunosuppression resulting in side effects and are not curative. It is estimated that 1 in 100 people worldwide suffer from celiac disease . 1 Our Solution : SNAP - TI, designed to induce Tregs and reduce the effector T cell response , both specific to the same antigens, without broad immunosuppression. Immunomodulator and antigens co - delivered by IM injection in self - assembled SNAP - TI designed to achieve a favorable antigen - specific Treg to Teffector ratio. VTP - 1000: Tolerance induction in Celiac Q4 2023: IND - Enabling studies expected to be completed with regulatory submission planned in Australia before the end of 2023 1 Singh. P, et al, Clinical Gastroenterology and Hepatology 2018. 2 Unpublished preclinical data, Barinthus Bio, Data on File. 0 20 40 0 1 2 3 4 Days after disease induction D i s e a s e s c o r e Treatment days 0.0 0.6 1.2 1.8 2.4 T r e g / T e f f r a t i o SNAP - TI Increases Treg to Teff Ratio in Mice to Impact Disease 2 [1] Vehicle [6] SNAPvax TV MOG; Rapamycin; 40 nmol Vehicle control SNAP - TI (MOG + mTORi)
Cancer Program
VTP - 850 for Prostate Cancer Prostate cancer is the 4th most common cancer diagnosis in the world 1 Prostate cancer worldwide 3 : 1 in 8 men will be diagnosed with prostate cancer in their lifetime .2 Novel immunotherapy candidate to prevent advanced disease 20 - 40% of patients with non - metastatic prostate cancer experience biochemical recurrence after local therapy (e.g., prostatectomy). ~1,400,000 new cases diagnosed deaths per year ~ 375 ,000 • Biochemical recurrence is indicated by rising PSA levels with no evidence of disease on conventional imaging, meaning the disease was not cured by local therapy. 4 • Treatment options for patients with biochemical recurrence include systemic therapies such as hormonal or chemotherapy, resulting in toxicity and side effects. VTP - 850 - a next generation ChAdOx - MVA multi - antigen product candidate designed to induce cytotoxic T cells and prevent advancement to metastatic disease. Barinthus Bio’s solution 1 WHO, 2022. 2 American Cancer Society, 2023 PSA: Prostate Specific Antigen . * Study Reference: NCT05617040 3 World Cancer Research Fund International. 2020. 4 Simon Ni, et al. Am Soc Clin Oncol Educ Book. 2022. 25
VTP - 800 First - Generation Single - Antigen Immunotherapy Showed Meaningful Reduction in PSA Phase 2 ADVANCE: VTP - 800 + Anti - PD - 1 in mCRPC 1 Antonarakis , E. et al. Journal of Clinical Oncology 2020 2 Data courtesy of Prostate Cancer Vaccine Group, Jenner Institute, UO. mCRPC : Metastatic Castrate Resistant Prostate Cancer VTP - 800 antigen: 5T4 Target patient population: 23 mCRPC patients enrolled Efficacy data readouts: • >50% reduction in PSA compared to baseline was seen in 22% of patients (5/23) • Historical comparator with a PSA response to anti - PD - 1 alone is ~9% 1 • 3 patients with PSA response also had measurable tumors and saw clinical responses S tudy in metastatic castration - resistant prostate cancer ( mCRPC ) patients using ChAdOx - MVA plus nivolumab 100 5 0 50 - 50 - 100 PSA change from baseline (%) Phase 2 ADVANCE: Serum PSA Results 2 26
PCA001 – Ph 1/2 Study Design Ongoing Phase 1/2 study for Multi - Antigen VTP - 850, a Next - Generation Candidate Hormone sensitive prostate cancer. Biochemical recurrence after definitive local therapy. No metastases by standard radiography. Inclusion Criteria Primary Endpoints Primary Endpoints Safety: incidence of AEs and SAEs. * Including 6 participants from Phase 1. ** If 4 or more of the 25 participants at the RP2R (including the Phase 1 participan ts who received the same dose regimen) have a PSA response, Stage 2 will be opened to enrolment of up to 100 additional participants. + Dosing dependent on outcome of Phase 1. Study Reference: NCT05617040 • PSA response, durability of PSA response, duration of PSA response, metastasis - free survival, time to metastasis, time to start of androgen deprivation therapy. Cohort 1 Low dose (N=3 - 6) IM/IM Cohort 2 Full dose (N=6) IM/IM Cohort 3 Full dose (N=6) IM/ IV VTP - 850 antigens: • 5T4 • PSA • PAP • STEAP Phase 1: Lead - in Phase VTP - 850 (N=15 - 18) Objective: Dose finding for Phase 2, evaluation of safety and immunogenicity. Phase 2: Main Phase VTP - 850 (N=125) Objective: Futility analysis, POC, durability of response rate. Stage 1 objective: Futility analysis based on PSA response. (N=25*) Dosing : IM + IM/ IV + Stage 2** objective: Establish proof of concept based on overall PSA response and duration of response. (N=100) Dosing: IM + IM/ IV+ 27
Partnered Programs 28
Barinthus Bio’s Partnered Pipeline 29 Program: COVID - 19 Coronavirus MERS Zoster NSCLC Partner AstraZeneca University of Oxford, CEPI CanSinoBIO Ludwig Cancer Research, CRUK Existing human clinical data ChAdOx “ MVA Prophylactic Programs VTP - 900 COVID - 19 Coronavirus* Licensed by OUI to AZ Fully approved in EMA/UK VTP - 500 MERS* Worldwide Initiation of Phase 2 VTP - 400 Zoster* Worldwide (excl. China) Initiation of Phase 1 Cancer Programs VTP - 600 NSCLC therapeutic in combo. with checkpoint inhibitor + chemo Worldwide (76% of Sub.) Phase 1/2a ongoing Product Candidate Program Preclinical Phase 1 Phase 2 Phase 3 Marketed Barinthus Bio Rights Status/Anticipated Upcoming Milestones * ChAdOx only
Company Highlights 30
Financial Overview & Catalysts Guiding the immune system to cure disease 31 Q4 2023 H1 2024 VTP - 1000 (Celiac) : Regulatory submission to initiate clinical trial 1 VTP - 200 (HPV) : Phase 1b /2 HPV001 final safety, efficacy and immunogenicity data 1 VTP - 1000 (Celiac) : Phase 1 GLU001 FPFV 1 VTP - 300 (HBV) : Phase 2b HBV003 interim analysis data 1 Expected near - term catalysts • $160.3 million as of September 30, 2023 • No debt or outstanding warrants • Estimated cash runway into the second quarter of 2025 Current cash position 1 Based on managements current estimates on expected clinical data milestones
Investment Highlights 32 Multiple anticipated near - term data readouts and clinical trial initiations from 3 Phase 2 programs and 2 Phase 1 programs. Established partnerships in 4 programs with leading institutions and biotech companies. Pipeline of 5 programs in infectious diseases, autoimmunity and cancer. Proprietary platforms ( ChAdOx , MVA, SNAP) designed to drive powerful immune responses in therapeutic and prophylactic settings. Clinical data in HBV, HPV, Prostate Cancer and the Oxford - AstraZeneca COVID - 19 vaccine. Expanding into autoimmunity with targeted immunotherapies in high unmet need areas with no current treatment, such as Celiac disease.
THANK YOU Guiding the Immune System to Cure Disease