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Jun 30, 2024
AcelRx Q2 2024 Earnings Report
Talphera announced second quarter 2024 financial results and provided a corporate update.
Key Takeaways
Talphera reported a net loss from continuing operations of $3.8 million for the second quarter of 2024. Patient screening has been initiated at multiple clinical sites for the NEPHRO CRRT registrational study.
Screening has been initiated at multiple clinical sites in the NEPHRO CRRT registrational study.
Clinical trial agreement terms with eight large academic institutions have been finalized.
Dr. Shakil Aslam joined Talphera as Chief Development Officer.
Cash, cash equivalents and investments balance was $14.0 million as of June 30, 2024.
AcelRx
AcelRx
Forward Guidance
Talphera expects the NEPHRO study to enroll and complete efficiently and anticipates a potential advantage for a timely approval of the product candidate next year.
Positive Outlook
- NEPHRO study should be enrolled and completed efficiently given the measurement of the primary endpoint is at 24 hours, with patients completing the study after 72 hours.
- Breakthrough Device Designation from the FDA potentially provides an advantage for a timely approval of the product candidate next year.
- Nafamostat has the potential to address known disadvantages of currently available U.S. products for anticoagulation of the extracorporeal circuit.
- Nafamostat has been used, as a standard of care, in Japan and South Korea for over 30 years.
- Finalized clinical trial agreement terms with eight large academic institutions including our potentially highest enrolling sites.
Challenges Ahead
- Risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release
- Talphera’s developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized
- Risks relating to Talphera’s ability to obtain regulatory approvals for its developmental product candidates
- Risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations
- Risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies