Q2 2024 Talphera Inc Earnings Call Transcript
Key Points
- Talphera Inc (TLPH) 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.
- 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.
Welcome to Talphera's second-quarter 2024 financial results conference call. This call is being webcasted live via the Events page of the Investors section of Talphera's website at www.talphera.com. This call is the property of Talphera, and any recording, reproduction or transmission of this call without the expressed written consent of Talphera is prohibited
As a reminder, this webcast is being recorded. You may listen to a replay of this webcast by going to the Investors section of Talphera's website.
I would now like to turn the call over to Raffi Asadorian, Talphera's Chief Financial Officer.
Thank you for joining us on the call today. This afternoon, we announced our second-quarter 2024 financial results and associated business updates in a press release. This press release can be found within the Investors section of our website. With me today are Vince Angotti, our Chief Executive Officer; and Dr. Pam Palmer,
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