Release Date: August 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Presented positive data from two Phase 2a clinical trials for imdusiran, showing promising results in hepatitis B treatment.
- Achieved undetectable hepatitis B surface antigen in 33% of patients in one trial, with a higher success rate of 67% in patients with baseline surface antigen less than 1,000 IU/ml.
- Extended projected cash runway into the fourth quarter of 2026, ensuring financial stability for ongoing and future projects.
- Reported that AB-101, a liver-centric oral small molecule PD-L1 checkpoint inhibitor, showed promising preclinical results and is advancing through clinical trials.
- Received $44.1 million in net proceeds from the issuance of common shares, bolstering financial resources.
Negative Points
- Decision to eliminate HBV discovery efforts, resulting in a 40% reduction in workforce, affecting discovery, research, and G&A functions.
- Discontinued the improved three clinical trial (AB-729-203) due to resource prioritization, potentially delaying some research progress.
- Incurred a one-time restructuring charge of approximately $3 million to $4 million due to workforce reduction.
- Ongoing litigation with Moderna and Pfizer/BioNTech regarding LNP intellectual property, with trial dates set for 2025, creating legal uncertainties.
- Uncertainty around the design and timing of the Phase 2b clinical trial for imdusiran, with no specific details provided yet.
Q & A Highlights
Q: Can you talk a little bit about what the Phase 2b trial would look like in terms of size and design and approximately how much it would cost to run? Will it include AB-101, interferon, and VTP-300?
A: We are in the planning stages of the Phase 2b study, so it’s premature to describe specific study design features or timing. We are evaluating all options, including the exciting data from our interferon combination and the upcoming nivolumab data from the improved two trial.
Q: For the improved two expansion cohort data expected in the second half of this year, will the data be announced in conjunction with any major medical conference?
A: We hope to present the data at a major medical conference, but we can't commit to that until we know the disposition of abstracts. We anticipate this will be the case but can confirm closer to the end of the year.
Q: Are there any plans to report new interim data from the improved one and improved two studies before year-end?
A: Yes, we plan to report new interim data, but the timing is to be determined.
Q: Are there any other impacts on your clinical programs other than the planned discontinuation of the improved three study? What about preclinical programs?
A: We do not anticipate any other impacts on our clinical programs. The focus is on advancing later-stage studies, and the streamlining positions the company well to advance imdusiran quickly. Preclinical programs are not affected by this streamlining.
Q: Is the next and possibly the only trial you will start the Phase 2b?
A: We are planning to move imdusiran into later-stage clinical development, likely a Phase 2b study. We are still in the process of finalizing details and will provide more information when available.
Q: How are you thinking about focusing on patients with baseline HBs less than 1,000?
A: We found that the response rate in patients with surface antigen less than 1,000 at baseline increased dramatically from 33% to 67%. This is a substantial patient population, and we are excited about the potential.
Q: Can you firm up when you might start the next clinical trial? Is it a first half 2025 study or later?
A: We can't provide specific timing or design details yet. We aim to start the trial as quickly as possible, pending some remaining data and discussions. We have the resources to kick this off on our own and fund it substantially with our current cash on hand.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
