Release Date: October 23, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Viking Therapeutics Inc (VKTX, Financial) reported positive data from four clinical programs, including VK2735 for obesity and VK2809 for NASH and fibrosis.
- The Phase II VENTURE trial for VK2735 demonstrated significant weight loss, with reductions up to 14.7% from baseline.
- VK2809 achieved its primary and secondary endpoints in the Phase IIb VOYAGE study, showing improvements in NASH resolution and fibrosis.
- The company has a strong financial position with $930 million in cash and equivalents, providing a runway for future clinical milestones.
- Viking Therapeutics Inc (VKTX) is advancing its pipeline with plans for Phase III development of VK2735 and further studies for VK2809 and VK0214.
Negative Points
- Viking Therapeutics Inc (VKTX) reported a net loss of $24.9 million for the third quarter of 2024, an increase from the previous year.
- Research and development expenses increased significantly, driven by manufacturing and clinical study costs.
- General and administrative expenses also rose, primarily due to stock-based compensation and legal services.
- The company faces challenges in scaling up manufacturing capacity for potential commercial production.
- There is uncertainty regarding the regulatory path and potential partnerships for the NASH program with VK2809.
Q & A Highlights
Q: Regarding the end of Phase II meeting for the subcutaneous VK2735, what are some things you'd like to iron out with the FDA? And how quickly would you be able to start Phase III after that?
A: Brian Lian, President and CEO: We will review the proposed protocol, doses, and trial size with the FDA to ensure nothing is overlooked. We aim to start Phase III promptly after receiving feedback.
Q: Will you be incorporating monthly dosing into the Phase III program, or is it a separate trial?
A: Brian Lian, President and CEO: Monthly dosing is feasible based on PK data, but it will likely be a standalone trial due to statistical challenges in transitioning mid-study.
Q: How are you thinking about testing the combination of amylin with VK2735?
A: Brian Lian, President and CEO: The greatest value of amylin is in combination with another mechanism. We plan to bring a compound into the clinic in 2025 and will rapidly follow with potential combinations.
Q: Can you comment on the safety and tolerability you would like to see for the 100-milligram dose to enable testing higher oral doses in Phase II?
A: Brian Lian, President and CEO: The dose level review team has not recommended discontinuing escalation, indicating a comfortable tolerability profile.
Q: How do you view the value split between the subcutaneous and oral forms of VK2735?
A: Brian Lian, President and CEO: The subcutaneous formulation is the anchor piece, with the oral being a nice add-on. We see the oral as a 20% opportunity and the injectable as an 80% opportunity.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
