What Talphera (TLPH) Said on Its Q3 Earnings Call

Key Points

• Talphera asked the FDA to approve ending Niyad’s study enrollment by Dec. 31, 2026, citing a sharp recruitment slowdown. Enrollment is above 75% of target and the company estimates the trial is more than 80% powered; FDA feedback is expected by year-end, with results four to six weeks after enrollment ends.
• The company raised Niyad’s estimated peak annual U.S. sales in CRRT to more than $200 million, based on physician research. Niyad remains investigational, so its commercial prospects depend on regulatory approval.
• Talphera reported $14.2 million in cash as of Sept. 30 and said it expects that balance, plus about $16 million in conditional financing tranches, to fund operations through at least a potential Niyad premarket approval in 2027.

Talphera NASDAQ: TLPH is seeking the U.S. Food and Drug Administration’s agreement to end enrollment in its Niyad study by Dec. 31, 2026, after a recent slowdown in recruiting critically ill patients, executives said on the company’s third-quarter earnings call.

The company also raised its estimate for Niyad’s peak annual U.S. sales in continuous renal replacement therapy, or CRRT, to more than $200 million, based on physician research. Niyad remains investigational, and its commercial potential depends on regulatory approval.

FDA Feedback Expected by Year-End

Chief Executive Officer Vince Angotti said Talphera has requested an FDA Sprint Meeting to discuss closing enrollment in the NEPHRO-CRRT registrational study with the evaluable patients enrolled by year-end, rather than reaching its original target of 70 patients. The company expects feedback before the end of December and top-line data four to six weeks after enrollment ends.

The trial is evaluating Niyad, a nafamostat-based regional anticoagulant, for use in the extracorporeal circuit during CRRT. The study is being conducted in U.S. hospital intensive care units.

Angotti said enrollment remains above 75% of the target and that the study is currently more than 80% powered for its primary endpoint. Statistical power is an estimate, based on study assumptions, of a trial’s ability to detect an effect if one exists; it does not guarantee a successful result.

Chief Medical Officer Dr. Shakil Aslam said the original 70-patient design had more than 90% power. The current estimate uses the same assumptions as the original sample-size calculation, he said. Aslam added that the study remains blinded and the company’s FDA submission is based on blinded data.

If the FDA does not agree to early closure, Talphera would continue enrolling toward 70 patients, Angotti said. Under that scenario, the company’s internal forecasts push completion into the first quarter of 2027.

Enrollment Slowdown and Regulatory Options

Aslam said the number of patients consented and enrolled dropped by 85% to 90% compared with the same period in 2025. He said the company had not identified a single cause, citing factors including patients meeting exclusion criteria and difficulties obtaining consent.

Angotti confirmed that Talphera has enrolled additional patients since its previous update but declined to provide a precise number. He described enrollment in the critically ill population as unpredictable and said the company wants more control over its timeline.

Aslam said Talphera’s briefing to the FDA includes statistical analyses, safety information and the company’s rationale for ending enrollment early. He said safety data from use outside the U.S., including Japan, would be submitted to the agency.

Besides an agreement or a refusal, Aslam said possible intermediate outcomes could include additional data as a postmarketing commitment or a filing while the study remains open to enroll more patients. Those were scenarios he identified, not FDA decisions.

Sales Estimate Rises as Company Plans Investor Event

Angotti said the higher peak-sales estimate reflects quantitative and qualitative research with physicians, including expected anticoagulant use and nafamostat’s potential role where existing approaches have limitations. Talphera plans to discuss the opportunity at an investor and analyst event in the first quarter of 2027.

Management also pointed to draft Kidney Disease: Improving Global Outcomes guidelines that identify nafamostat as an alternative anticoagulant for CRRT when citrate cannot be used. Angotti said a recently published study favoring CRRT over intermittent hemodialysis in critically ill patients with acute kidney injury could support growth in the broader CRRT market.

Asked whether difficulty enrolling patients undermined the sales forecast, Angotti said clinical trial requirements, including eligibility criteria and consent, do not necessarily reflect real-world use.

Cash and Spending

Chief Financial Officer Raffi Asadorian said Talphera had $14.2 million in cash on Sept. 30. The company believes that balance, together with future conditional financing tranches, will provide sufficient capital through at least a potential Niyad premarket approval expected in 2027.

Two conditional tranches remain, totaling approximately $16 million. If their conditions are met, Talphera expects them to close around the time it announces study completion and releases top-line data, Asadorian said.

Third-quarter research and development and selling, general and administrative expenses, excluding noncash stock-based compensation, rose to $3.8 million from $3.3 million a year earlier. Asadorian attributed the increase primarily to higher Niyad development spending and commercial pre-launch preparations. He also said Talphera plans to replace its Form S-3 shelf registration statement, which expires Nov. 30, 2026.

About Talphera (NASDAQ:TLPH)

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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