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Dec 31, 2023
AcelRx Q4 2023 Earnings Report
Announced fourth quarter 2023 financial results and provided a corporate update.
Key Takeaways
Talphera, Inc. reported Q4 2023 financial results, highlighting a company transformation and focus on Niyad, with revenues of $0.3 million and a net loss of $4.5 million. The company completed a rebranding, secured $26 million in committed capital, and is advancing Niyad into a registrational trial.
Talphera completed a corporate rebranding and transformation, shifting focus to Niyad.
The company secured $26 million in committed capital through royalty monetization and equity financings.
First patient enrollment in the NEPHRO CRRT registrational study is expected in Q1 2024, with a PMA submission projected by the end of 2024.
Cash and investments were $9.4 million as of December 31, 2023, expected to provide cash runway to a potential Niyad approval in Q2 2025.
AcelRx
AcelRx
Forward Guidance
Talphera anticipates a potential FDA approval of Niyad targeted for the second quarter of 2025.
Positive Outlook
- First patient enrollment in its NEPHRO CRRT registrational trial by the end of Q1 2024.
- Top-line data read out of its NEPHRO CRRT registration trial by the end of Q3 2024.
- Completion of the NEPHRO CRRT trial with an expected PMA application submitted before the end of 2024.
- Committed funding will provide sufficient capital to fund Talphera through a potential approval of Niyad, targeted in the second quarter of 2025.
- Expected cash operating expenses for 2024, including potential committed capital arising from successful announcement of NEPHRO CRRT trial data and Talphera stock trading price performance.
Challenges Ahead
- Risks relating to Talphera's product development activities and ongoing commercial business operations.
- Risks related to the ability of Talphera and its business partners to implement development plans, launch plans, forecasts and other business expectations.
- Risks related to unexpected variations in market growth and demand for Talphera's commercial and developmental products and technologies.
- Risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct the required clinical studies.
- Risks relating to Talphera’s ability to obtain regulatory approvals for its developmental product candidates.