Vince Angotti: Nafamostat Study Progressing Well
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 13 2026
0mins
Cash and investments balance was $21.1M as of March 31. "In early March, we announced the attainment of 50% enrollment in the NEPHRO CRRT study evaluating nafamostat. With continued steady enrollment, we have well exceeded this level, and continue to expect study completion later this year," stated Vince Angotti, CEO. "Our clinical study sites and principal investigators remain focused on enrollment and delivering a high quality study as they are eager for a potential alternative anticoagulant for Continuous Renal Replacement Therapy. The investor and analyst event held in March also highlighted the need for an alternative, given the disadvantages of the currently used products, heparin and citrate. If approved, we continue to believe nafamostat will fill an unmet need in the market as a regional anticoagulant for CRRT".
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Analyst Views on TLPH
Wall Street analysts forecast TLPH stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.822
Low
3.00
Averages
3.25
High
3.50
Current: 0.822
Low
3.00
Averages
3.25
High
3.50
About TLPH
Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of therapies for use in medically supervised settings. The Company’s portfolio consists of nafamostat product candidates and pre-filled syringe product candidates. The Company’s lead product candidate, Niyad, is a lyophilized formulation of nafamostat and is being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit. Niyad is used in adult patients undergoing continuous renal replacement therapy (CRRT). LTX-608 is its nafamostat formulation for direct IV infusion being explored as an investigational product for one or more indications, including antiviral treatment, or treatment of acute respiratory distress syndrome (ARDS) disseminated intravascular coagulation (DIC), or acute pancreatitis. The Company’s two ready-to-use pre-filled syringe (PFS) product candidates include Fedsyra and phenylephrine.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Clinical Trial Progress: Talphera has achieved 50% enrollment in the NEPHRO study and expects to complete enrollment in 2026, with a PMA filing for Niyad targeted for 2027, indicating significant advancement in key product development.
- Strong Financial Position: As of March 31, 2026, Talphera reported a cash balance of $21.1 million and closed a $4.1 million financing tranche during the quarter, ensuring sufficient capital ahead of critical milestones.
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- Future Outlook: Management expresses optimism for top line data release in the second half of 2026, anticipating results to be announced within a month after the last patient exits, further bolstering market confidence in the company's future growth.
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- 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.
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See More
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- NEPHRO-CRRT Study Progress: The study is enrolling 70 adult patients who cannot tolerate heparin or are at risk of bleeding, primarily assessing the mean post-filter activated clotting time of Niyad versus placebo over the first 24 hours, potentially paving the way for FDA approval.
- Drug Characteristics Analysis: Nafamostat has over three decades of usage experience in Japan and South Korea, and its unique pharmacokinetic and pharmacodynamic properties make it an ideal candidate for regional anticoagulation in CRRT, filling a significant market gap if approved.
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See More
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- Cash Position: As of December 31, 2025, Talphera reported a cash and investments balance of $20.4 million, providing a financial cushion for future operations and R&D initiatives.
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See More
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- Strong Financial Position: As of March 31, 2026, Talphera reported a cash balance of $21.1 million and closed a $4.1 million financing tranche during the quarter, ensuring sufficient capital ahead of critical milestones.
- Cost Management: Cash operating expenses for Q1 2026 totaled $3.9 million, up from $2.9 million in Q1 2025, primarily due to increased Niyad development costs, reflecting the company's ongoing investment in R&D.
- Future Outlook: Management expresses optimism for top line data release in the second half of 2026, anticipating results to be announced within a month after the last patient exits, further bolstering market confidence in the company's future growth.
See More
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- Cash Position: As of March 31, 2026, the company's cash and investments balance stood at $21.1 million, ensuring sufficient funding for future R&D and operations, thereby boosting investor confidence.
- Expense Increase: Combined R&D and SG&A expenses for Q1 2026 totaled $3.9 million, significantly up from $2.9 million in Q1 2025, primarily driven by higher Niyad® development costs, reflecting the company's ongoing commitment to new product development.
- Impact of Non-Cash Expenses: Excluding non-cash stock-based compensation, expenses for Q1 2026 were $3.7 million compared to $2.7 million in 2025, indicating operational cost pressures that may affect future profitability.
See More
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- Earnings Announcement: Talphera (TLPH) is set to release its Q1 earnings on May 13 after market close, with a consensus EPS estimate of -$0.08, indicating ongoing challenges in profitability.
- Historical Performance: Over the past year, Talphera has beaten EPS estimates 75% of the time, reflecting relative stability in earnings forecasts, although the revenue beat rate stands at only 25%, suggesting a need for stronger revenue growth.
- Recent Revisions: In the last three months, Talphera's EPS estimates have seen one upward revision with no downward adjustments, indicating increased analyst confidence in the company's future performance, which could positively impact its stock price.
- Investor Focus: As the earnings report approaches, investors and analysts will closely monitor Talphera's financial data to assess its performance and growth potential in a competitive market environment.
See More
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.
See More
Talphera Presents Innovative Therapies at International Conference
- Research Presentation: Talphera will showcase two studies on Niyad and Nafamostat at the AKI & CRRT 2026 conference from March 29 to April 2, highlighting their potential applications in CRRT, which could transform the current anticoagulant landscape.
- NEPHRO-CRRT Study Progress: The study is enrolling 70 adult patients who cannot tolerate heparin or are at risk of bleeding, primarily assessing the mean post-filter activated clotting time of Niyad versus placebo over the first 24 hours, potentially paving the way for FDA approval.
- Drug Characteristics Analysis: Nafamostat has over three decades of usage experience in Japan and South Korea, and its unique pharmacokinetic and pharmacodynamic properties make it an ideal candidate for regional anticoagulation in CRRT, filling a significant market gap if approved.
- Clinical Application Outlook: Talphera's Niyad has received FDA Breakthrough Device Designation, and if successfully launched, it will become the first regional anticoagulant approved for use in CRRT, expected to significantly enhance patient treatment outcomes and safety.
See More
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- Cash Position: As of December 31, 2025, Talphera reported a cash and investments balance of $20.4 million, providing a financial cushion for future operations and R&D initiatives.
- Rising Expense Forecast: Cash operating expenses for 2026 are projected to range between $17 million and $18 million, up from approximately $13 million in 2025, primarily driven by the NEPHRO CRRT study and associated costs.
- Clinical Trial Progress: The increase in expenses also includes costs related to finalizing the NEPHRO CRRT registration trial, expected to be completed later this year, marking a significant step towards filing for Premarket Approval with the FDA.
See More
