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Mar 31, 2024
AcelRx Q1 2024 Earnings Report
Talphera announced first quarter 2024 financial results and provided a corporate update.
Key Takeaways
Talphera reported a net loss from continuing operations of $4.0 million for the first quarter of 2024, compared to net income of $0.1 million for the same period in 2023. As of March 31, 2024, the company's cash and cash equivalents balance was $18.6 million.
First patients at multiple sites are expected to be enrolled in the NEPHRO CRRT registrational study in Q2 2024.
Dr. Shakil Aslam, an expert in renal diseases, including acute kidney injury, joined Talphera as Chief Development Officer.
Cash and investments at March 31, 2024 were $18.6 million.
Combined R&D and SG&A expenses for the first quarter of 2024 totaled $4.2 million.
AcelRx
AcelRx
Forward Guidance
Talphera expects the NEPHRO study will complete quickly once patients begin enrolling and plans to provide an updated expected study completion date. Talphera anticipates Dr. Aslam's nephrology expertise will support the development and commercial preparation of Niyad.
Positive Outlook
- First patients expected to be enrolled in the NEPHRO CRRT registrational study in Q2 2024.
- Clinical trial agreements with five large academic institutions have been finalized.
- Dr. Shakil Aslam joined Talphera as Chief Development Officer.
- Talphera expects the NEPHRO study will complete quickly once patients begin enrolling.
- Dr. Aslam's nephrology expertise will support the development and commercial preparation of Niyad.
Challenges Ahead
- Initial site activation for the NEPHRO study has taken longer than expected.
- Previous guidance of having top-line data available by September 30 will be revised.
- Net loss from continuing operations of $4.0 million.
- The company anticipates a revision to the expected completion date for the NEPHRO study.
- Delays in site activation have impacted the timeline for top-line data availability.