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Tuesday, H.C. Wainwright reiterated a Buy rating and a $6.00 price target on Talphera (NASDAQ:TLPH) shares following a favorable update from the company. Currently trading at $0.49, the stock sits well below analysts’ price targets ranging from $3.00 to $6.00. According to InvestingPro analysis, Talphera appears undervalued based on its Fair Value assessment. Talphera announced that the U.S. Food and Drug Administration (FDA) has agreed to a reduced enrollment target for its NEPHRO CRRT study, which is testing Niyad, a lyophilized formulation of nafamostat, as an anticoagulant for use in the extracorporeal circuit.
Originally set to include 166 patients, the study’s enrollment target has been lowered to 70 patients. This adjustment keeps the study on track for completion by the end of 2025. The reduction in patient numbers is still expected to provide the study with a 90% power to meet its primary endpoint, a slight decrease from the prior estimate of 99%. With a market capitalization of just $8.43 million and a current ratio of 4.42, InvestingPro data shows the company maintains strong liquidity to support its clinical programs.
The NEPHRO CRRT study’s enrollment criteria have also been updated. The new criteria will now include patients who have been undergoing continuous renal replacement therapy (CRRT) for more than 48 hours, as well as heparin-tolerant patients at specific institutions. This change comes after it was determined that the exclusion of patients on CRRT for over 48 hours was no longer necessary, as the clinical endpoints previously associated with this duration are not relevant to the study’s primary goal.
The primary endpoint aims to compare the mean post-filter activated clotting time of patients using Niyad against a placebo over the first 24 hours of treatment. According to Talphera’s management, this endpoint will not be affected by the updated enrollment criteria.
The positive comments from H.C. Wainwright come as Talphera remains focused on meeting its study goals and advancing the development of Niyad. With the FDA’s agreement and the updated study parameters, the company is poised to continue its research within the anticipated timeframe. Despite recent challenges, including a 23% decline in share price over the past week, InvestingPro analysis reveals the company holds more cash than debt on its balance sheet. Discover 8 additional exclusive ProTips and comprehensive analysis in the Pro Research Report, available with an InvestingPro subscription.
In other recent news, Talphera Inc reported its Q4 2024 financial results, emphasizing a strategic focus on cost management and clinical advancements. The company successfully reduced its combined R&D and SG&A expenses from $4.6 million in Q4 2023 to $3 million in Q4 2024. Talphera also secured up to $14.8 million in private placement financing to support its ongoing clinical trials. A significant milestone was achieved with FDA approval to reduce the size of its nephro CRRT study, potentially accelerating its path to market. The company plans to expand its clinical study sites to 13 by mid-2025, aiming to complete its nephro CRRT study by the end of the year. Analysts have noted a challenging earnings environment, with projected EPS losses through FY 2025. Despite these challenges, the company remains focused on its strategic objectives and has outlined plans to achieve FDA approval in 2026.
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