Q2 2024 Arbutus Biopharma Corp Earnings Call

In This Article:

Participants

Lisa Caperelli; Vice President of Investor Relations; Arbutus Biopharma Corp

Michael McElhaugh; Interim President, Chief Executive Officer, Director; Arbutus Biopharma Corp

Karen Sims; Chief Medical Officer; Arbutus Biopharma Corp

David Hastings; Chief Financial Officer; Arbutus Biopharma Corp

Dennis Ding; Analyst; Jefferies LLC

Roy Buchanan; Analyst; JMP Securities

Keay Nakae; Analyst; Chardan Capital Markets

Presentation

Operator

Good day, and thank you for standing by. Welcome to the Arbutus Biopharma 2024 second quarter financial results and corporate update. (operator instructions)
Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Lisa Caperelli, Vice President of Investor Relations. Please go ahead.

Lisa Caperelli

Thank you, Jill. Good morning, everyone, and thank you for joining Arbutus second quarter 2024 financial results and corporate update call. Joining me today from the Arbutus Executive Team are Michael McElhaugh, Interim President and Chief Executive Officer; Dr. Karen Sims, Chief Medical Officer; David Hastings, Chief Financial Officer; and Dr. Mike Sofia, Chief Scientific Officer.
Mike McElhaugh will begin with a corporate update, followed by Karen, who will review our ongoing clinical programs. Dave will then provide a review of the company's second quarter 2024 financial results. After our prepared remarks, we will open the call for Q&A.
Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements, which are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in our annual report on Form 10-K, our quarterly report on Form 10-Q, which we filed today, and from time to time and other documents filed with the SEC.
With that, I'll turn the call over to Mike McElhaugh. Mike?

Michael McElhaugh

Good morning, everyone, and thank you for joining us today.
In the second quarter of 2024, we made significant advancements in our pursuit of developing a functional cure for patients with hepatitis B and driving value for our company and shareholders. Most importantly, we presented positive data from two Phase 2a clinical trials, combining our RNAi therapeutic imdusiran with different immunomodulators.
Both of these data sets support the continued development of imdusiran as a cornerstone in an HBV functional cure treatment regiment. Of note, the improved one clinical trial demonstrated undetectable hepatitis B surface antigen in 33% of patients from Cohort A1, who were treated with 48 weeks of imdusiran and 24 weeks of interferon.
More importantly, 67% of those patients with baseline surface antigen less than 1,000 international units per mil had undetectable hepatitis B surface antigen. In addition, six patients four from Cohort A1 and two from Cohort A2, who achieved undetectable surface antigen after receiving imdusiran plus 24 weeks of interferon, stopped all therapy and maintained undetectable surface antigen and HBV DNA in early follow-up, a precursor to a functional cure.
To put this in context, if these six patients continue to maintain undetectable levels of HBV DNA and surface antigen for 24 weeks, while off all therapy, they would be considered functionally cured. We look forward to following the trajectory of these patients and potentially achieving our goal of reaching a functional cure rate that is equal to or greater than 20%, a goal of it aligns with a number of [KOLs] in the HBV field.
We are now prioritizing advancing imdusiran and into Phase 2b clinical development and preparations are ongoing. In addition, to the follow-up data from the patients from improved one that are trending towards a functional cure. We expect to report preliminary data from the nivolumab arm of the improved two trial evaluating imdusiran plus VTP-300, in the second half of this year.
As a reminder, improved to -- includes an additional cohort of patients who received imdusiran plus nucleoside analogue therapy for 24 weeks, followed by VTP-300 plus up to two low doses of nivolumab, an approved anti-PD-1 monoclonal antibody.
Because we are now focused on advancing imdusiran into Phase 2b clinical development and ensuring we have the resources to do so. We have made the difficult decision to further streamline the company by eliminating our HBV discovery efforts. These actions will result in a reduction in workforce of 40% affecting our discovery, research and G&A functions.
We know changes that impact our people are not easy, and we are committed to providing -- departing employees with support as they transition to their new next roles. At the same time, we are confident that Arbutus remains well positioned for the future. I want to emphasize how grateful we are to all our employees, especially those departing for their dedication and passion in developing novel therapeutics that may lead to a functional cure in hepatitis B.
In addition to eliminating our research discovery efforts, we have also decided prior to dosing any patients to discontinue our recently initiated improved three trial also known as AB-729-203, which was a Phase 2a trial evaluating the addition of their nivolumab to imdusiran.
Our decision to discontinue the improved three clinical trial is not related to any concerns regarding imdusiran or our belief that the addition of controlled checkpoint inhibition may be a key component of a functional cure regimen.
The decision was based solely on prioritization of resources for the advancement of imdusiran into a Phase b -- Phase 2b clinical trial and the projected availability of improved three clinical data given the advancement of AB-101 through Phase 1 clinical development. I want to emphasize that our decision to discontinue this clinical trial, has no impact on our small -- small molecule, PD-L1 checkpoint inhibitor. AB-101, that is differentiated from checkpoint antibodies and is currently in a Phase 1a/ 1b clinical trial.
Recall, AB-101 is liver centric and in preclinical studies had typical small molecule pharmacokinetics and therefore, likely a much shorter duration of effect than long acting antibodies. These features were designed with the goal of minimizing systemic exposures and reducing the chance of immune-related adverse events that are often seen with checkpoint antibodies.
It is for these reasons that we continue to remain excited about the potential of AB-101 in hepatitis B and are continuing to evaluate multiple ascending doses of AB-101 in healthy subjects in our Phase 1a/1b clinical trial. Importantly, the actions today have allowed us to extend our projected cash runway into the fourth quarter of 2026.
Before I turn the call over to Karen, I would like to provide a brief update on the litigation with moderna and Pfizer/BioNTech around our LNP intellectual property. In the moderna case, next steps include expert reports and expert depositions. The court has set April 21, 2025 is a trial date for this case, which is of course, subject to change. The Pfizer/BioNTech lawsuit is ongoing with no updates at this time.
With that, I'll now turn the call over to Karen to review the data we presented at EASL. Karen?