Talphera (NASDAQ:TLPH – Get Free Report) posted its quarterly earnings data on Monday. The company reported ($0.06) earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of ($0.08) by $0.02, FiscalAI reports.
Here are the key takeaways from Talphera’s conference call:
- 50% enrollment in the NEPHRO CRRT registrational study triggered a financing tranche (gross proceeds of $4.1M); management reports $20.4M cash & investments and says remaining tranches should provide runway through a potential FDA approval with enrollment completion and PMA submission expected in the second half of 2026.
- Key opinion leaders emphasized a clear unmet need for CRRT anticoagulation — current options (heparin and citrate) are either unpredictable/systemic or effective but operationally complex, and many centers use no anticoagulation because of these limitations.
- Investigators said nafamostat (Niyad) is viewed as simpler to use, largely regional (stays in the circuit), easier to titrate, and likely to be adopted as a frontline option at many sites — potentially extending filter life, reducing nursing burden, and increasing anticoagulation uptake.
- The trial’s conservative inclusion/exclusion criteria (e.g., baseline ACT and bleeding-risk restrictions) have made enrollment challenging and contributed to a modest timeline slip, creating execution risk even though management says enrollment pace has improved.
Talphera Stock Down 8.9%
Shares of TLPH opened at $0.73 on Wednesday. The stock has a market cap of $34.03 million, a P/E ratio of -1.97 and a beta of 0.47. The business’s 50 day moving average price is $0.88 and its 200-day moving average price is $1.05. Talphera has a 52 week low of $0.38 and a 52 week high of $1.57.
Analyst Ratings Changes
Check Out Our Latest Analysis on TLPH
Insider Buying and Selling
In related news, CEO Vincent J. Angotti acquired 105,364 shares of the stock in a transaction on Thursday, February 12th. The stock was acquired at an average price of $0.81 per share, for a total transaction of $85,344.84. Following the completion of the purchase, the chief executive officer owned 586,954 shares of the company’s stock, valued at $475,432.74. This represents a 21.88% increase in their ownership of the stock. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which can be accessed through the SEC website. Also, insider Shakil Aslam bought 35,000 shares of the company’s stock in a transaction on Thursday, February 12th. The stock was bought at an average cost of $0.81 per share, for a total transaction of $28,350.00. Following the completion of the acquisition, the insider directly owned 83,178 shares of the company’s stock, valued at approximately $67,374.18. This represents a 72.65% increase in their position. The SEC filing for this purchase provides additional information. Insiders purchased 220,364 shares of company stock worth $178,495 in the last 90 days. Corporate insiders own 5.70% of the company’s stock.
Institutional Investors Weigh In On Talphera
Institutional investors have recently made changes to their positions in the company. Nantahala Capital Management LLC increased its position in shares of Talphera by 75.3% during the third quarter. Nantahala Capital Management LLC now owns 3,492,519 shares of the company’s stock valued at $3,120,000 after acquiring an additional 1,500,000 shares in the last quarter. Cantor Fitzgerald L. P. bought a new position in Talphera in the 4th quarter valued at approximately $658,000. Geode Capital Management LLC boosted its stake in Talphera by 107.0% during the 4th quarter. Geode Capital Management LLC now owns 342,987 shares of the company’s stock valued at $391,000 after purchasing an additional 177,294 shares during the last quarter. Renaissance Technologies LLC increased its holdings in shares of Talphera by 412.6% in the 4th quarter. Renaissance Technologies LLC now owns 257,380 shares of the company’s stock worth $293,000 after purchasing an additional 207,166 shares in the last quarter. Finally, Diadema Partners LP bought a new stake in shares of Talphera in the 4th quarter worth $156,000. Hedge funds and other institutional investors own 37.67% of the company’s stock.
Talphera Company Profile
Talphera, Inc, a specialty pharmaceutical company, focuses on the development and commercialization of therapies for use in medically supervised settings. Its lead product candidate is Niyad, a lyophilized formulation of nafamostat, which is under an investigational device exemption as an anticoagulant for the extracorporeal circuit. It is also developing LTX-608, an anti-inflammatory and antiviral potential for the treatment of multiple conditions, including disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis; Fedsyra, a pre-filled ephedrine syringe; and PFS-02, a pre-filled phenylephrine syringe.
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