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Sep 30, 2024

AcelRx Q3 2024 Earnings Report

Announced third quarter 2024 financial results and provided a corporate update.

Key Takeaways

Talphera reported its third quarter 2024 financial results, highlighting progress in the NEPHRO CRRT study with activated screening sites and an expectation to complete the study next year. The company's cash and investments totaled $11.1 million as of September 30, 2024.

Five clinical sites are actively screening patients for the NEPHRO CRRT study, with multiple patients having completed the study.

Two additional large-volume clinical sites are expected to begin screening patients in the fourth quarter.

The company met with physicians and investigators at Kidney Week 2024, confirming the need for alternative anticoagulants for CRRT.

Cash, cash equivalents, and investments totaled $11.1 million as of September 30, 2024.

Total Revenue
$0
Previous year: $117K
-100.0%
EPS
-$0.13
Previous year: -$0.08
+62.5%
Gross Profit
$0
Previous year: $117K
-100.0%
Cash and Equivalents
$11.1M
Previous year: $13.4M
-17.2%
Free Cash Flow
-$2.94M
Previous year: -$2.96M
-0.8%
Total Assets
$21M
Previous year: $23.3M
-9.7%

AcelRx

AcelRx

Forward Guidance

Talphera anticipates increased NEPHRO study enrollment rates and the activation of additional study sites, with the expectation of completing the study next year.

Positive Outlook

  • Increased enrollment rates in the NEPHRO CRRT study expected.
  • Activation of additional study sites anticipated.
  • Potential for nafamostat to avoid risks of systemic anticoagulation.
  • Nafamostat has the potential to address unmet needs in anticoagulation of the extracorporeal circuit.
  • Breakthrough Device Designation could provide an advantage.

Challenges Ahead

  • Clinical studies may not be fully enrolled or completed.
  • Developmental product candidates may not be beneficial or successfully commercialized.
  • Talphera may not obtain regulatory approvals for its product candidates.
  • Talphera and its partners may face challenges in implementing development and commercial launch plans.
  • Talphera's liquidity and capital resources may be insufficient to conduct its clinical studies.