Core Insights - Talphera, Inc. announced the acceptance of two abstracts for presentation at the 31st Annual International Conference on Advances in Critical Care Nephrology: AKI & CRRT 2026, highlighting its focus on innovative therapies for medically supervised settings [1] Group 1: Abstract Presentations - The first poster presentation will discuss a randomized, placebo-controlled, multi-center study evaluating the safety and efficacy of Niyad in patients undergoing Continuous Renal Replacement Therapy (CRRT) who cannot tolerate heparin or are at higher risk of bleeding [2] - The second poster presentation will assess the pharmacokinetics of nafamostat in a porcine model of AKI receiving CRRT, indicating that over 95% of nafamostat was removed by the hemofilter when administered pre-filter [3] Group 2: NEPHRO CRRT Study - The NEPHRO CRRT Study is a prospective, double-blinded trial designed to enroll 70 adult patients in U.S. hospital intensive care units, focusing on those who cannot tolerate heparin or are at risk for bleeding [5] - The primary endpoint of the study is the mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours, with key secondary endpoints including filter lifespan and dialysis efficacy [5] Group 3: Product Information - Nafamostat is a synthetic serine protease inhibitor with anticoagulant, anti-inflammatory, and potential anti-viral activities, while Niyad is a lyophilized formulation of nafamostat currently under investigation as an anticoagulant for the extracorporeal circuit [6][8] - Niyad has received Breakthrough Device Designation Status from the FDA, indicating its potential significance in medical treatment [6]

Core Insights - Talphera, Inc. reported its fourth quarter and full year 2025 financial results, highlighting significant progress in its NEPHRO CRRT clinical study and financial position [1][2][3] Financial Performance - The company reported a net loss of $3.8 million for Q4 2025, equating to $0.06 per share, compared to a net loss of $1.9 million or $0.07 per share in Q4 2024 [4][14][18] - Total operating costs and expenses for Q4 2025 were $3.5 million, up from $3.0 million in Q4 2024, primarily due to increased R&D and G&A expenses [4][14][20] - Cash and investments stood at $20.4 million as of December 31, 2025, a significant increase from $8.9 million at the end of 2024 [4][19] Clinical Development - Talphera achieved a 50% enrollment milestone in the NEPHRO CRRT study, with 35 patients enrolled out of a target of 70 [2][4][11] - All 12 clinical sites are now operational for patient enrollment, which is expected to accelerate the study's completion by 2026 [1][4] - The NEPHRO CRRT study aims to evaluate the efficacy of Niyad, a formulation of nafamostat, as an anticoagulant in patients undergoing renal replacement therapy [10][11] Future Guidance - The company anticipates cash operating expenses in the range of $17 million to $18 million for 2026, driven by the NEPHRO CRRT study and related expenses [3][5] - A virtual investor and analyst day is scheduled for March 23, 2026, to provide updates on the company's progress and insights from principal investigators involved in the NEPHRO CRRT study [1][6]

Core Insights - Talphera, Inc. will host a virtual investor and analyst event on March 23, 2026, to discuss Niyad® for continuous renal replacement therapy (CRRT) [1] - The event will feature principal investigators from the NEPHRO CRRT study, which evaluates Niyad's efficacy [1][2] Company Overview - Talphera, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for medically supervised settings [9] - The lead product candidate, Niyad, is a lyophilized formulation of nafamostat, which has received Breakthrough Device Designation from the FDA [9] Product and Study Details - Nafamostat is a broad-spectrum serine protease inhibitor with anticoagulant, anti-inflammatory, and potential antiviral properties, used in CRRT for over 30 years in Japan and South Korea [2] - Niyad aims to serve as a regional anticoagulant for patients who cannot tolerate heparin or are at risk of bleeding, addressing limitations of current anticoagulants [2] - The NEPHRO CRRT study is a prospective, double-blinded trial enrolling 70 adult patients in U.S. ICUs, focusing on the mean post-filter activated clotting time as the primary endpoint [7] Expert Involvement - Blaithin McMahon, PhD, and Joao Teixeira, MD, are principal investigators with extensive backgrounds in nephrology and critical care, contributing to the study's credibility [4][5]

Core Insights - Talphera, Inc. has achieved a significant milestone in its NEPHRO CRRT clinical trial by enrolling 17 out of the planned 70 patients, which is approximately 25% of the total enrollment target [1][2] - The company is on track to complete the study by the end of 2025, supported by an accelerated recruitment rate from new clinical sites [1][2] Enrollment Progress - The NEPHRO CRRT trial has seen an increase in enrollment, with 17 patients now participating, up from 15 just a week prior [2] - Over 90% of the enrolled patients are coming from newly targeted clinical sites, indicating a successful re-launch of the study [2] Study Design and Objectives - The NEPHRO CRRT Study is a prospective, double-blinded trial conducted in up to 14 U.S. hospital intensive care units, focusing on 70 adult patients who cannot tolerate heparin or are at risk for bleeding [3] - The primary endpoint is the mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours, with key secondary endpoints including filter lifespan and dialysis efficacy [3] Product Information - Niyad is a lyophilized formulation of nafamostat, a synthetic serine protease inhibitor with anticoagulant and anti-inflammatory properties, currently under investigation as an anticoagulant for extracorporeal circuits [4][5] - The product has received Breakthrough Device Designation from the FDA, highlighting its potential significance in medical applications [5] Company Overview - Talphera, Inc. specializes in developing and commercializing innovative therapies for medically supervised settings, with a focus on products like Niyad [5]

Financial Data and Key Metrics Changes - The company reduced its expected cash operating expense guidance for 2025 to a range of $16 million to $17 million, down from the previous range of $17 million to $19 million [20] - Cash operating expenses for 2025 totaled $3.7 million compared to $4.3 million for 2024, indicating a decrease primarily due to reductions in personnel and general administrative expenses [20][21] - The cash balance as of June 30, 2025, was $6.8 million, which includes proceeds from the first tranche of financing [21] Business Line Data and Key Metrics Changes - The enrollment rate for the Nephros study has more than doubled since May, with a strong acceleration observed in the last six weeks [5][12] - The company has shifted its focus to new clinical study sites, specifically targeting nephrologists as principal investigators, which has led to improved enrollment rates [7][12] Market Data and Key Metrics Changes - There is a growing interest from healthcare providers in Nafamostat due to ongoing shortages of heparin and citrate, which are commonly used anticoagulants [9][39] - The company is advancing a compassionate use IDE for Nafamostat, indicating a strong market potential for the product if approved [9][15] Company Strategy and Development Direction - The company is focused on completing the nephro CRRT registrational trial by the end of 2025, with a clear regulatory path and breakthrough designation from the FDA [17][19] - The strategy includes adding new clinical study sites with a focus on nephrology to enhance patient enrollment and engagement [12][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the low clinical, regulatory, and commercial risks associated with the Nafamostat program, citing its established track record in Japan and South Korea [17] - The management team is optimistic about the potential for Nafamostat to become the only FDA-approved regional anticoagulant for CRRT if approved [10][19] Other Important Information - The company is in discussions with multiple institutions regarding the compassionate use of Nafamostat for specific patient populations that do not respond well to existing anticoagulants [9][15] - The company has made significant changes to its clinical study design, including reducing the study size and adjusting the target profile of clinical sites [4][6] Q&A Session Summary Question: What is the expected enrollment acceleration to reach the 70 patient target by year-end? - Management indicated that the enrollment rates are significantly increasing with new sites, and they are confident in reaching the target based on current trends [25][26] Question: Is there an opportunity to leverage data from compassionate use for future publications? - Management confirmed that data collected from compassionate use patients will contribute to a larger safety dataset, which could be beneficial for future publications and commercial uptake [30][33] Question: What is the status of heparin and citrate shortages? - Management noted that heparin shortages are episodic and ongoing, while citrate shortages are also being reported, affecting supply predictability [38][39] Question: What are the main components driving down operating expenses? - Management expects operating expenses to increase in the second half of the year due to rising enrollment rates [43] Question: What gives confidence in the new site initiations? - Management highlighted improved vetting processes and historical data on site performance, indicating high confidence in having new sites operational by the end of the third quarter [50][56]