Anteris Technologies - Q2 2024 Activity Report and Financial Highlights
ANTERIS TECHNOLOGIES LTD (AVR) Share Update July 2024 Wednesday 31st
Anteris Technologies Reports Promising Q2 2024 Results and FDA Feedback
Anteris Technologies Ltd (ASX: AVR) has released its quarterly activity report for the period ending 30 June 2024, showcasing promising clinical data, successful financial raises, and positive feedback from the US FDA.
Instant Summary:
- New data confirms optimal valve positioning with ComASUR Delivery System.
- Cardiac MRI data shows restoration of normal aortic flow in 41 patients.
- Successful first-in-human TAVR in TAVR in SAVR using DurAVR.
- Positive feedback from the US FDA on pivotal phase 3 study.
- $23 million raised from the placement of one million new ordinary shares.
- Cash balance of $10.8 million as of 30 June 2024, with an additional $30 million raised in late July.
Clinical Achievements
During Q2 2024, Anteris Technologies made significant strides in its clinical programs. Notably, the latest cohort of 13 patients in the DurAVR THV First-in-Human (FIH) Study confirmed optimal valve positioning using the ComASUR Delivery System. This system enables controlled deployment and precise alignment with the patient's native aortic valve.
Additionally, new cardiac MRI data on 41 patients demonstrated the restoration of normal aortic flow and haemodynamics, leading to significant left ventricular mass regression. These results were presented at the New York Valves 2024 conference by Dr. João Cavalcante.
Regulatory Progress
Anteris received positive feedback from the US FDA regarding key elements of its pivotal phase 3 study. The FDA indicated support for the design aspects of the global, pivotal study, which will be the first randomized, all-risk, head-to-head registration trial for TAVR. The agency also approved a single-arm, valve-in-valve registry to run concurrently with the primary aortic stenosis arm.
Financial Highlights
Financially, Anteris raised $23 million from the placement of one million new ordinary shares at $23 each. The company also maintained a cash balance of $10.8 million as of 30 June 2024. In late July, an additional $30 million was raised through a capital raise for the issue of 1.875 million new shares.
Operating cash flows for the quarter included significant investments in research and development, staff costs, and administration. The company reported a net cash outflow of $20.855 million from operating activities, reflecting its ongoing commitment to advancing its DurAVR THV technology.
The positive clinical data and regulatory feedback are likely to boost investor confidence in Anteris Technologies. The successful financial raises provide the company with the necessary capital to continue its pivotal phase 3 study and other developmental activities. Overall, the announcement is expected to have a positive impact on the company's stock price.
Investor Reaction:
Analysts are likely to react positively to the clinical and regulatory progress made by Anteris Technologies. The successful financial raises and strong cash position further enhance the company's outlook. However, investors will be closely monitoring the progress of the pivotal phase 3 study and any additional regulatory updates.
Conclusion:
Investors should keep an eye on Anteris Technologies' upcoming milestones, particularly the pivotal phase 3 study. The company's continued clinical and financial progress positions it well for future growth. Staying informed on Anteris Technologies' developments will be crucial for making informed investment decisions.