Talphera to Host Third Quarter Financial Results and Corporate Update Call and Webcast on Wednesday, November 12, 2025
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 05 2025
0mins
Should l Buy TLPH?
Source: PRnewswire
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.
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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: 0.746
Low
3.00
Averages
3.25
High
3.50
Current: 0.746
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.
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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- 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.
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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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- Investor Day Event: Talphera will host a virtual Investor and Analyst Day on March 23, 2026, expected to share more business updates and the latest progress on clinical studies, further enhancing engagement and transparency with investors.
See More
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- Clinical Study Progress: Talphera has achieved 50% enrollment in the NEPHRO CRRT clinical study, with all 12 clinical sites now capable of enrolling patients, which is expected to accelerate patient recruitment and enhance study efficiency towards a 2026 completion.
- Successful Financing: The company successfully closed a $4.1 million financing tranche as a condition for reaching the 35-patient enrollment milestone, thereby strengthening its liquidity to support ongoing R&D efforts.
- Financial Status: As of December 31, 2025, Talphera reported cash and investments totaling $20.4 million, despite a net loss of $3.8 million in Q4 2025, indicating a continued increase in R&D expenditures.
- Future Outlook: Cash operating expenses are projected to range between $17 million and $18 million in 2026, up from approximately $13 million in 2025, primarily driven by the NEPHRO CRRT study and related costs, reflecting the company's focus on future market opportunities.
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- 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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- Earnings Highlights: Talphera's Q4 2025 GAAP EPS of -$0.06 beats expectations by $0.01, indicating a slight improvement in financial performance despite still being in the red.
- 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
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- Clinical Study Progress: Talphera announced that the NEPHRO CRRT clinical study has achieved 50% enrollment, with expected completion in 2026, indicating positive advancements in drug development that may pave the way for future market launches.
- Successful Financing: The company successfully closed a $4.1 million financing tranche, strengthening its financial position and providing robust funding support for upcoming clinical trials and product development, thereby boosting investor confidence.
- Financial Status Update: As of December 31, 2025, Talphera reported $20.4 million in cash and investments, reflecting financial stability in operations and ensuring continued support for ongoing R&D activities.
- Investor Day Event: Talphera will host a virtual Investor and Analyst Day on March 23, 2026, expected to share more business updates and the latest progress on clinical studies, further enhancing engagement and transparency with investors.
See More
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- Clinical Study Progress: Talphera has achieved 50% enrollment in the NEPHRO CRRT clinical study, with all 12 clinical sites now capable of enrolling patients, which is expected to accelerate patient recruitment and enhance study efficiency towards a 2026 completion.
- Successful Financing: The company successfully closed a $4.1 million financing tranche as a condition for reaching the 35-patient enrollment milestone, thereby strengthening its liquidity to support ongoing R&D efforts.
- Financial Status: As of December 31, 2025, Talphera reported cash and investments totaling $20.4 million, despite a net loss of $3.8 million in Q4 2025, indicating a continued increase in R&D expenditures.
- Future Outlook: Cash operating expenses are projected to range between $17 million and $18 million in 2026, up from approximately $13 million in 2025, primarily driven by the NEPHRO CRRT study and related costs, reflecting the company's focus on future market opportunities.
See More
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See More
