Talphera Announces Acceptance of Two Abstracts at International Conference on Advances in Critical Care Nephrology
- Abstract Acceptance: Talphera announced that two of its research abstracts have been accepted for presentation at the 2026 International Conference on Advances in Critical Care Nephrology, showcasing its innovative research in the CRRT field, which may enhance the company's reputation and influence in the medical sector.
- NEPHRO-CRRT Study: This study aims to evaluate the safety and efficacy of Niyad in patients who cannot tolerate heparin, planning to enroll 70 patients across 14 U.S. hospitals; if successful, it will address a significant unmet medical need in the CRRT domain.
- Nafamostat's Potential: Research indicates that nafamostat exhibits unique pharmacokinetic properties in a porcine model, effectively controlling systemic activated clotting time; if approved by the FDA, it will become the first regional anticoagulant for CRRT, presenting substantial market opportunities.
- Innovative Drug Development: Talphera's Niyad, a lyophilized formulation of nafamostat, has received Breakthrough Device Designation from the FDA, and if successfully commercialized, it will provide significant business opportunities and competitive advantages for the company.
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Financial Results Announcement: Talphera, Inc. will release its third quarter 2025 financial results on November 12, 2025, followed by a live webcast and conference call at 4:30 p.m. ET to discuss the results and business updates.
Webcast and Conference Call Details: The webcast can be accessed through Talphera's website, and a replay will be available for 90 days. Investors can join the conference call using specific dial-in numbers and a conference ID.
Company Overview: Talphera, Inc. is a specialty pharmaceutical company focused on developing innovative therapies for medically supervised settings, with its lead product candidate, Niyad™, currently under investigation as an anticoagulant.
Regulatory Status: Niyad™ has received Breakthrough Device Designation from the FDA, highlighting its potential significance in medical applications.

Surge in Biotech Stocks: U.S.-listed biotech and healthcare stocks experienced significant after-hours gains, with Turn Therapeutics Inc. leading the way, surging 134.29% after its Nasdaq debut.
Momentum and Anticipation: Other companies like Talphera Inc. and Ionis Pharmaceuticals Inc. also saw notable increases, driven by momentum and upcoming presentations, indicating a strong interest in the biotech sector.

Nebius Group's Contract with Microsoft: Nebius Group N.V. shares surged 49.6% in pre-market trading after announcing a $19.4 billion, five-year GPU infrastructure contract with Microsoft for its new data center in Vineland, New Jersey.
Pre-Market Stock Movements: Several stocks experienced significant pre-market trading changes, with Big Tree Cloud Holdings rising 625.1% and Santech Holdings increasing 533.3%, while NFT Limited and Taitron Components saw declines of 32.2% and 28.8%, respectively.
Private Placement Details: Talphera, Inc. has entered into agreements for a private placement that could raise up to $29 million, with $17 million expected from the first closing on September 10, 2025, and an additional $12 million contingent on study results and stock price conditions.
Strategic Investment and Future Plans: CEO Vince Angotti highlighted the funding as a means to support Talphera's programs, including Niyad, which aims to be the first FDA-approved regional anticoagulant for CRRT, while also noting CorMedix's investment as a validation of Niyad's potential.

Financial Overview: As of March 31, 2025, Talphera, Inc. reported cash and investments totaling $9.8 million, with a net loss from continuing operations of $2.7 million for the first quarter, an improvement from a $4.0 million loss in the same period last year.
Clinical Development Update: The company has activated three new clinical study sites for its NEPHRO CRRT trial and expects to add five more by mid-year, aiming to complete the study with 70 patients by the end of 2025, following recent FDA approvals that modified study parameters.







