Talphera (NASDAQ:TLPH) Posts Earnings Results, Hits Expectations

Talphera (NASDAQ:TLPH) released its quarterly earnings results on Thursday. The company reported ($0.05) earnings per share (EPS) for the quarter, meeting analysts’ consensus estimates 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%

NASDAQ TLPH traded down $0.01 during trading on Thursday, hitting $1.03. The stock had a trading volume of 93,335 shares, compared to its average volume of 221,178. The company has a market capitalization of $53.72 million, a PE ratio of -3.83 and a beta of 0.77. The firm has a 50 day moving average price of $1.12 and a 200 day moving average price of $1.01. Talphera has a twelve month low of $0.69 and a twelve month high of $1.57.

Wall Street Analyst Weigh In

A number of equities analysts recently weighed in on TLPH shares. Weiss Ratings reaffirmed a “sell (d-)” rating on shares of Talphera in a research report on Thursday, October 15th. Wall Street Zen raised Talphera to a “hold” rating in a research report on Saturday, August 8th. Finally, HC Wainwright reissued a “buy” rating and issued a $3.00 target price on shares of Talphera in a research report on Thursday, August 13th. Two equities research analysts have rated the stock with a Buy rating, one has assigned a Hold rating and one has issued a Sell rating to the stock. According to MarketBeat.com, the company currently has an average rating of “Hold” and a consensus target price of $3.00.

About Talphera

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.