Talphera (NASDAQ:TLPH) Issues Earnings Results

Key Points

• Talphera reported quarterly EPS of -$0.05, matching analyst consensus.
• The company asked the FDA to let its NEPHRO-CRRT study stop enrolling by December 31, 2026; the study is over 80% powered, but enrollment has slowed sharply. FDA feedback is expected by year-end, with results anticipated four to six weeks after enrollment closes.
• Talphera estimates Niyad could generate over $200 million in peak annual U.S. sales, subject to approval. It reported $14.2 million in cash and expects cash plus conditional financing to fund operations through a potential 2027 approval.

Talphera (NASDAQ:TLPH - Get Free Report) announced its quarterly earnings results on Thursday. The company reported ($0.05) earnings per share (EPS) for the quarter, meeting the consensus estimate of ($0.05), FiscalAI reports.

Here are the key takeaways from Talphera's conference call:

• Talphera asked the FDA to allow the NEPHRO-CRRT study to stop enrolling by December 31, 2026, with the patients enrolled by then; the company says the study is already more than 80% powered for its primary endpoint. FDA feedback is expected by year-end, and top-line results are expected four to six weeks after enrollment closes.
• Enrollment has slowed sharply, with consented and enrolled patients down 85%–90% versus the same period in 2025, though the company did not identify a specific cause. If the FDA does not agree to early closure, Talphera says it will continue toward its original 70-patient target, which could push completion into the first quarter.
• The company raised its estimate of Niyad’s potential peak annual U.S. CRRT sales to more than $200 million, based on physician market research. Talphera also cited updated KDIGO draft guidelines recognizing nafamostat as an alternative and evidence it believes could support broader CRRT use; the sales opportunity remains contingent on approval.
• Talphera reported $14.2 million in cash at September 30 and said it expects cash plus two conditional financing tranches totaling about $16 million to fund operations through a potential 2027 Niyad PMA approval. The financing depends on meeting conditions, while quarterly cash operating expenses increased to $3.8 million from $3.3 million a year earlier.

Talphera Stock Down 1.4%

Shares of TLPH traded down $0.01 during trading hours on Thursday, reaching $1.03. 93,335 shares of the company traded hands, compared to its average volume of 221,178. The stock has a market capitalization of $53.72 million, a PE ratio of -3.83 and a beta of 0.77. Talphera has a fifty-two week low of $0.69 and a fifty-two week high of $1.57. The stock has a fifty day simple moving average of $1.12 and a 200 day simple moving average of $1.01.

Analyst Upgrades and Downgrades

TLPH has been the subject of a number of recent research reports. Weiss Ratings reissued a "sell (d-)" rating on shares of Talphera in a research note on Thursday, October 15th. HC Wainwright restated a "buy" rating and set a $3.00 price objective on shares of Talphera in a research report on Thursday, August 13th. Finally, Wall Street Zen raised Talphera to a "hold" rating in a research note on Saturday, August 8th. Two investment analysts have rated the stock with a Buy rating, one has issued a Hold rating and one has assigned a Sell rating to the company. Based on data from MarketBeat.com, Talphera currently has an average rating of "Hold" and a consensus price target of $3.00.

Talphera Company Profile

Talphera, formerly known as AcelRx Pharmaceuticals, is a specialty pharmaceutical company focused on developing and commercializing therapies for acute pain. The company's lead product is DSUVIA, a sublingual tablet containing sufentanil, an opioid analgesic designed to provide rapid relief for adults experiencing acute pain severe enough to require an opioid. DSUVIA is intended for use in medically supervised settings, including hospitals, surgical centers and other certified health-care environments.

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