Release Date: August 20, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Brii Biosciences Ltd (BRIBF, Financial) has a clear mission to develop a functional cure for hepatitis B, addressing a significant global health burden.
- The company has a robust portfolio of HBV candidates, including siRNA, monoclonal antibody, and therapeutic vaccine, all of which have been granted Breakthrough Therapy Designation by the China NMPA.
- Recent data from clinical trials show promising results, including a 57% improvement in overall HB surface antigen loss rate with BRII-179 plus PEG interferon alfa.
- The company has a strong cash position, sufficient to support R&D and operations through the end of 2027.
- Brii Biosciences Ltd (BRIBF) is actively seeking partners to further develop non-HBV programs, indicating a strategic approach to resource allocation.
Negative Points
- The exact mechanism for achieving a functional cure for HBV remains unknown, posing a challenge for the company's research efforts.
- There is a significant decrease in other income, primarily due to reduced government grants, which could impact financial stability.
- Research and development expenses have decreased significantly, which may indicate potential delays or scaling back of certain projects.
- Administrative expenses have also decreased, primarily due to workforce reduction in non-core areas, which could affect operational efficiency.
- The company is still in the early stages of discovery efforts for new areas, with no expected outcomes in the next two years, potentially delaying future growth opportunities.
Q & A Highlights
Q: So a quick question on your expectations for the Phase II ENSURE trial top line coming later this year. What are you hoping to see both on the efficacy and safety side and what would motivate you to keep moving forward into later-stage trials?
A: This study is important for us in several ways. It evaluates the siRNA plus pegylated interferon dosing with a control arm of pegylated interferon. Key objectives include validating the 100 mg versus 200 mg dosing regimen, understanding the individual contribution of siRNA, and evaluating a fourth cohort for pretreatment strategy. The data will be key in designing later-stage trials.
Q: How have your interactions been so far with the China regulatory authorities around HBV? Is there anything different in terms of what might be required in China versus in the US?
A: We are validated with our data sets achieving Breakthrough Designation status for all three compounds, enabling rapid and efficient conversations with CDE. We don't see substantial differences in regulatory paths globally versus in China but are actively engaged to ensure effective study designs.
Q: How is your discovery team under new leadership shaping the direction of your R&D programs, particularly in the HBV space? Are there any new strategic initiatives or areas of focus under consideration?
A: The new team is focusing on adjacent areas relevant to our existing programs, leveraging our knowledge and expertise. These are early efforts, and we don't expect significant developments in the next two years from our discovery efforts.
Q: Can you provide more details on the recent data from the Phase II study of BRII-179 in combination with PEG interferon alfa?
A: The Phase II study showed a 57% improvement in overall HB surface antigen loss rate in patients treated with BRII-179 plus PEG interferon alfa compared to the placebo group. The treatment was generally safe and well-tolerated, with no new risks identified.
Q: What are the key takeaways from the data presented at the EASL Congress for BRII-179 and elebsiran combination therapy?
A: The data provided first-time direct evidence that immune responses induced by a therapeutic vaccine are associated with HB surface antigen reduction and viral control. The combination therapy elicited substantial HBV-specific B and T cell responses, indicating potential for breaking immune tolerance and achieving a functional cure.
Q: What are the financial highlights for the first half of 2024?
A: We ended the first six months of 2024 with a strong cash position, sufficient to support R&D and operations through the end of 2027. Cash and cash equivalents were CNY2,477.8 million, with a decrease primarily due to daily operations and R&D activities. Other income was CNY70.9 million, a decrease mainly due to reduced government grants.
Q: How have you managed to control operational expenses?
A: Through pipeline prioritization, resource optimization, internalization of certain clinical development activities, and cost-saving measures of third-party contractors. R&D expenses decreased by 37.6% compared to the first half of 2023, primarily due to reduced third-party contracting costs and employee costs.
Q: What are the next steps for your non-HBV programs?
A: We continue to seek partners to advance our non-HBV programs. For example, we submitted an IND application for a Phase I PK bridging study with BRII-693 in China for a global Phase III trial. We also have ongoing studies in HIV and CNS programs, with data expected in the fourth quarter of this year.
Q: What are your expectations for the upcoming critical data readouts?
A: We expect several critical data readouts from multiple Phase II studies in the fourth quarter, including early top-line results from the ENSURE study and findings from our partner Vir's MARCH Part B study and SOLSTICE study. These will inform our strategies for achieving a functional HBV cure.
Q: How do you plan to deliver continued shareholder value?
A: By advancing innovative therapies with the goal of broadening choice and access for patients. Our strong cash position supports our development needs through 2027, and we are focused on maximizing the impact of our HBV clinical programs while seeking partners for our other promising candidates.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
