Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Talphera Inc (TLPH, Financial) has finalized clinical trial agreement terms with eight large academic institutions for the NEPHRO study.
- The company received FDA approval to increase the number of NEPHRO study sites to a maximum of 14, which is expected to expedite study completion.
- Dr. Shakil Aslam, with over 20 years of clinical research experience in nephrology, has joined Talphera Inc (TLPH) as Chief Development Officer.
- Talphera Inc (TLPH) has made positive advancements in manufacturing and related CMC efforts for Niyad, with all active ingredient and finished drug production meeting specifications.
- The company has strong support from its largest investor, Nantahala, ensuring adequate funding to reach potential PMA approval of Niyad.
Negative Points
- The NEPHRO study has experienced delays due to administrative processes at academic institutions.
- The company is not prepared to provide guidance on expected study completion and PMA filing timelines.
- Operating expenses are expected to increase for the remaining quarters of the year as study enrollment accelerates.
- The planned second close of financing has been delayed and requires amendment.
- Initial study sites have lower enrollment potential, which may slow down the overall study progress.
Q & A Highlights
Q: Can you provide an update on the number of patients that have completed the study or have been screened to date?
A: Screening has just begun within the last several weeks, primarily at lower enrollment potential sites. These sites were selected for the quality of care and diversity of patients. No patients have completed the study yet, but the balance of our highest enrolling sites should be enrollment-ready by the end of this month. (Vincent Angotti, CEO; Pamela Palmer, Co-Founder & CMO)
Q: What are the expected operating costs for the remainder of the year?
A: The estimated range of cash operating expenses for the year has been reduced to $19 million to $21 million. We had about $8 million year-to-date, so we can expect around $11 million for the second half of the year. (Raffi Asadorian, CFO)
Q: Can you clarify the plans for the financing amendment with Nantahala?
A: We are working on amending the September 30 date to a new date that aligns with the study completion and announcement of the pivotal trial milestone. Initial discussions have been positive, and Nantahala remains supportive. (Raffi Asadorian, CFO; Vincent Angotti, CEO)
Q: What gives you confidence that you can initiate the new and additional study sites in a timely manner?
A: We have learned from the initial site initiation process and are focusing on sites that can quickly handle contracting and budgeting. We have already started initial contact with an additional 20 sites to funnel down to the ultimate 14. (Vincent Angotti, CEO; Pamela Palmer, Co-Founder & CMO)
Q: Can you provide more context around the scale of the additional study sites?
A: The additional sites are expected to be higher enrolling, based on their CRRT patient volume and ability to quickly process paperwork. We are selecting sites that can streamline the administrative process. (Pamela Palmer, Co-Founder & CMO)
Q: What changes have been instituted since Dr. Aslam joined the company?
A: Dr. Aslam has been handholding sites through the contracting and budgeting phase, leveraging his deep knowledge and relationships in the nephrology field to expedite the process. (Pamela Palmer, Co-Founder & CMO)
Q: What does "highest enrolling sites" mean in a trial that hasn't enrolled anybody yet?
A: These sites have higher patient volumes that fit our criteria, based on feasibility questionnaires filled out by the institutions. The initial sites were specialty sites with lower patient flow, but the upcoming sites are expected to have higher enrollment potential. (Vincent Angotti, CEO; Pamela Palmer, Co-Founder & CMO)
Q: Why include potentially lower enrolling sites in the study?
A: These sites were selected for the quality of the PI, their influence on guidelines, and the diversity of patients they provide, which could be important for the data set. (Vincent Angotti, CEO; Pamela Palmer, Co-Founder & CMO)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
