ABUS — Arbutus Biopharma Corporation

Summary of ABUS Q3 2024 Earnings Call

1. Key Financial Results and Metrics

• Cash Position: Arbutus Biopharma ended Q3 2024 with approximately $131 million in cash, cash equivalents, and marketable securities, a slight decrease from $132 million at the end of 2023.
• Cash Burn: The company reported a cash burn of $54.5 million during the first half of 2024 and expects a total cash burn for the year to be between $63 million and $67 million.
• Runway: The current cash runway is projected to fund operations into the fourth quarter of 2026.

2. Strategic Updates and Business Highlights

• Clinical Trials:
  • Multiple abstracts featuring data on imdusiran were accepted for presentation at the upcoming Liver Meeting 2024. This includes two late-breaker presentations from Phase IIa trials (IM-PROVE I and II).
  • The IM-PROVE I trial showed that 33% of patients achieved sustained surface antigen loss, with 67% in a subset with baseline surface antigen below 1,000 IU/mL.
  • IM-PROVE II trial data indicated that 95% of patients achieved surface antigen levels below 100 IU/mL after treatment with imdusiran.
• AB-101 Development: The oral PD-L1 checkpoint inhibitor AB-101 is progressing through a Phase Ia/Ib trial, with preliminary data expected in the first half of 2025.

3. Forward Guidance and Outlook

• Arbutus plans to advance imdusiran into a Phase IIb clinical trial as a cornerstone of a potential functional cure regimen for chronic HBV.
• The company is focused on achieving a 20% functional cure rate, which is considered a meaningful benchmark compared to current therapies.
• Additional data from the IM-PROVE trials will be presented at AASLD next week, which may influence future clinical strategies.

4. Bad News, Challenges, or Points of Concern

• Cash Management: While the cash runway is sufficient, the company did not issue shares under its ATM program in Q3, indicating potential challenges in raising funds.
• Litigation Risks: Ongoing litigation with Moderna and Pfizer/BioNTech regarding LNP intellectual property could pose uncertainties, with trial dates set for September 2025 and a Markman hearing in December 2024.
• Clinical Trial Risks: The efficacy of imdusiran and AB-101 in achieving desired outcomes remains to be fully validated, and the upcoming data releases are critical for investor confidence.

5. Notable Q&A Insights

• Functional Cure Data: Management clarified that the 20% functional cure rate is an aspirational goal, with ongoing assessments of both cohorts in the trials to determine efficacy.
• Denominator Clarification: For Cohort A1, the functional cure denominator will be around 12 patients, and the company is optimistic about achieving the 20% target.
• Future Study Designs: There is an openness to exploring various study designs for future trials based on emerging data, particularly regarding the imdusiran lead-in approach.
• AB-101 Expectations: The upcoming results from the AB-101 study will focus on HBV patients, but specific data from earlier trial phases will be shared when appropriate.

Overall, Arbutus Biopharma is advancing its clinical programs with a focus on HBV treatments while navigating financial and legal challenges. The upcoming data presentations are pivotal for the company's future trajectory.