Release Date: November 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Talphera Inc (TLPH, Financial) has successfully onboarded five active clinical trial sites with plans to expand to seven by the end of the year, indicating progress in their ongoing registrational trial.
- The company is implementing innovative strategies to improve patient enrollment, such as automated text notifications and report generations from electronic medical records.
- Talphera Inc (TLPH) has a clear regulatory path with a product candidate that has breakthrough designation from the FDA, which provides quick review and response times.
- The company has a strong track record of safety and efficacy for their product, Nafamostat, which has been used as an anticoagulant for CRRT for 30 years in Japan and South Korea.
- Talphera Inc (TLPH) has expressed confidence in the commercial potential of Nafamostat, citing a clear unmet need for an alternative anticoagulant in CRRT.
Negative Points
- The initial activation and enrollment rates at clinical trial sites have not met Talphera Inc (TLPH)'s timing expectations, leading to adjustments in their strategy.
- The company anticipates needing additional capital before the completion of the Nephro study, indicating potential financial constraints.
- There is a risk of patient exclusion in the trial due to current safety requirements, which may not reflect the real-world application of the product.
- Some clinical trial sites have been slow to meet projected enrollment numbers, which could delay the study's completion.
- Talphera Inc (TLPH) faces commercial risks due to the disadvantages of current anticoagulants used during CRRT, despite their belief in Nafamostat's potential.
Q & A Highlights
Q: Can you provide more details on the optimization of the screening process for the Nephro CRRT study and why changes were made?
A: Vince Angotti, CEO, explained that initial sites were not meeting enrollment expectations, prompting a focus on high-volume sites with broader patient populations. Dr. Shakil Aslam, Chief Medical Officer, added that they are implementing automated notifications to improve patient capture before CRRT initiation and using electronic medical records to identify potential candidates earlier.
Q: How is the existing safety data from Japan and South Korea being utilized in the FDA approval process?
A: Dr. Shakil Aslam noted that the FDA has considered the long track record of safety from Japan and South Korea, where Nafamostat has been used for 30 years. The FDA required additional preclinical studies to confirm safety, which have been completed and will be submitted.
Q: What is the expected distribution of patient enrollment across the clinical trial sites?
A: Vince Angotti stated that newer sites are expected to contribute more to patient enrollment due to their larger medical ICU populations, compared to initial sites which have been slower to meet projections.
Q: Can you share any feedback from physicians or patients involved in the Nephro CRRT study?
A: Dr. Shakil Aslam reported positive feedback from physicians regarding the ease of titrating Nafamostat to target ACT levels. However, as the study is blinded, detailed feedback is limited.
Q: Are there any additional measures planned to accelerate patient enrollment in the Nephro CRRT study?
A: Vince Angotti mentioned ongoing evaluations of study design and site selection, with a focus on larger medical ICUs. Rafi Asadorian, CFO, added that further undisclosed measures are being considered to enhance enrollment.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.