Talphera Q1 Earnings Call Highlights

Talphera (NASDAQ:TLPH) said it has made continued progress enrolling patients in its NEPHRO CRRT study and remains on track to complete the trial this year, as management outlined first-quarter 2026 financial results and business updates on the company’s earnings call.

Chief Executive Officer Vince Angotti said the company has “well exceeded” the 50% enrollment milestone it announced in early March for the NEPHRO study, which is evaluating Niyad, the company’s investigational nafamostat product for anticoagulation in continuous renal replacement therapy, or CRRT.

“With this continued progress, we believe we are well-positioned to complete enrollment in the NEPHRO CRRT study this year and file the PMA for a targeted potential approval of Niyad in 2027,” Angotti said.

NEPHRO study enrollment remains central focus

Angotti said protocol changes adopted last year, along with the addition of clinical study sites fitting a new target profile, have positioned the company to complete the study in 2026. He said 9 of the 12 activated study sites align with the new profile, which emphasizes nephrologists as the lead investigators. Those sites have enrolled more than 90% of the patients in the study, according to Angotti.

The company also expects to add two more institutions, bringing it to the 14 sites granted by the U.S. Food and Drug Administration. Angotti said the two new sites are not expected to be major contributors to overall enrollment because they are joining late in the study, but both have significant CRRT populations. He added that one of the sites is among the top five CRRT-administering hospitals in the country based on the company’s data.

Talphera plans to disclose the additional site names through an update to clinicaltrials.gov, Angotti said.

Management reiterated that the company is not planning additional interim enrollment updates before completion. In response to an analyst question, Angotti said the next key enrollment-related announcement is expected to be “last patient out.” Chief Financial Officer Raffi Asadorian said top-line data should follow within about a month after that point, noting that the study has a 24-hour primary endpoint and a 72-hour secondary endpoint.

“It’s a very quick study,” Asadorian said. “We’re cleansing the data along the way. It’ll be a quick announcement for that top-line data.”

Angotti said the company continues to expect top-line results in the second half of 2026 and remains confident the study will be completed this year.

Management highlights feedback from trial sites

Angotti said he and Chief Medical Officer Dr. Shakil Aslam have been visiting study sites in recent weeks and described investigators and staff as highly engaged. He said sites have expressed interest in having a new CRRT anticoagulant approved for use.

Aslam said principal investigators, investigators and nurses involved in the study have commented positively on the ease of administering the intervention. Because the study is blinded, he did not distinguish between placebo and active treatment when discussing trial observations.

“They are all very, very impressed with the ease of administering this intervention,” Aslam said.

He said the first 24 hours require more intensive monitoring, but after that the monitoring burden declines. Aslam said site staff have observed little variability in test results once patients are stabilized within a target range.

Aslam described the study’s titration protocol, saying patients begin at a predefined starting dose and have activated clotting time checked 15 minutes later using a bedside handheld device. He said about 70% of cases are in the target range at the initial dose, while some patients require additional titration. By the end of the first hour, he said, patients are in the expected range.

Aslam said nafamostat’s metabolism is not dependent on a specific organ, which differentiates it from some other drugs that may be affected by liver or kidney function changes. He cited heparin and citrate as examples of medications where organ function can affect response.

“The beauty about nafamostat, it really is not dependent on any organ,” Aslam said. “That’s the reason why once you hit the target level, it essentially remains stable.”

Asked about current anticoagulation practices at the company’s study sites, Aslam said none of the 12 sites uses citrate as standard of care. He said two or three sites use citrate only as a rescue option if a patient continues to clot. He also said one site uses heparin as standard of care, while two or three use heparin as rescue therapy.

“Majority of our sites right now … they don’t really have any first-line anticoagulant that they use for every single patient,” Aslam said.

Cash position and expenses

Asadorian said Talphera ended the first quarter with $21.1 million in cash as of March 31, 2026. He said the company believes that cash, combined with future conditional financing tranches, will provide sufficient capital through at least a potential Niyad PMA approval expected next year.

During the quarter, Talphera closed a $4.1 million financing tranche from its March 2025 private placement. Asadorian said two remaining conditional financing tranches total approximately $16 million and, if conditions are met, are expected to close around the time the company releases top-line data and announces completion of the study later this year.

Cash operating expenses, defined as combined research and development and selling, general and administrative expenses, totaled $3.9 million in the first quarter of 2026, compared with $2.9 million in the same period of 2025. Excluding non-cash stock-based compensation expense, those expenses were $3.7 million, compared with $2.7 million a year earlier.

Asadorian said the increase was primarily due to higher Niyad development expenses tied to increased enrollment, as well as an increase in certain general and administrative expenses.

Company targets potential 2027 approval

Angotti said the company continues to see Niyad as a potential option to address unmet needs in CRRT anticoagulation, if approved by the FDA. He cited feedback from key opinion leaders at a March investor and analyst event, who discussed disadvantages with currently available anticoagulants and their belief that nafamostat could fill a market need.

“Our commitment, enthusiasm to bring the potentially new regional anticoagulant for CRRT to the market next year is unwavering,” Angotti said at the close of the call.

About Talphera (NASDAQ:TLPH)

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.