Talphera Q2 Earnings Call Highlights

Talphera (NASDAQ:TLPH) said it had reached 75% enrollment in its NEPHRO-CRRT registrational study and remains on track to complete enrollment later in 2026, as the company prepares for a potential commercial launch of its nafamostat anticoagulant candidate for continuous renal replacement therapy, or CRRT.

Chief Executive Officer Vince Angotti said all final clinical sites are now activated for the placebo-controlled study, which is evaluating nafamostat’s safety and effectiveness as an anticoagulant used during CRRT. The trial is being conducted in hospital intensive care units, with nephrologists serving as principal investigators.

“With all of our final clinical sites now activated, we have reached 75% enrollment in the NEPHRO-CRRT study,” Angotti said. “This progress allows us to increasingly turn our attention to the commercial aspects of nafamostat.”

Trial Timeline and Investigator Feedback

Chief Financial Officer Raffi Asadorian said Talphera expects top-line data about four to five weeks after completing enrollment. The company could then take roughly three additional months to prepare a premarket approval, or PMA, filing, potentially including an interim meeting with the FDA. Talphera expects to submit the PMA in the first half of 2027.

Angotti said the company’s current plan is to launch nafamostat upon any approval, without a meaningful interval between approval and commercialization. However, the product has not been approved.

Chief Medical Officer Dr. Shakil Aslam said the study’s site realignment had been completed, with all sites now led by nephrologists and recruiting primarily from medical ICUs. He said the FDA had also granted protocol modifications that support the company’s enrollment timeline.

Aslam said investigators have found the trial procedures straightforward, though he emphasized that NEPHRO-CRRT is blinded and that feedback does not distinguish between treatment arms. The company’s first independent data safety monitoring meeting occurred several months ago, according to Aslam, and the monitoring group recommended continuing the study without changes after identifying no new patient risks or findings.

Based on limited blinded observations, Aslam said titration has been in line with Talphera’s expectations. He said roughly 80% to 85% of patients were in the therapeutic range at the protocol’s starting infusion rate, while nearly all patients reached that range within about 30 minutes. The protocol allows dose adjustments every 15 minutes using bedside activated clotting time testing.

Aslam also said most patients have remained well below the protocol’s maximum permitted dose and generally have not required repeated dose adjustments after reaching the therapeutic range.

KDIGO Draft Guidelines Reference Nafamostat

Management highlighted the public-review draft of the 2026 clinical practice guideline for acute kidney injury and acute kidney disease from Kidney Disease: Improving Global Outcomes, or KDIGO. Angotti said the draft guideline references nafamostat as an acceptable regional anticoagulant, marking the first time the drug has been recommended in KDIGO guidance.

The public comment period for the guideline closed in May. Aslam said he did not know the exact timeline for final publication but estimated that a final draft could be available within three to six months.

According to Aslam, the current draft frames nafamostat as an alternative when citrate is unavailable or contraindicated. He said citrate is used by about 25% of U.S. institutions, while approximately 75% of institutions do not have it available. He also cited citrate’s complexity and potential limitations in patients with liver disease and certain metabolic issues.

Angotti said citrate is the only regional anticoagulant currently used in the U.S., though he noted it is not FDA-approved for CRRT. He said nafamostat is already widely used during CRRT in Japan and South Korea. Talphera cited a 2018 Japanese national survey in which nafamostat was used in about 80% of cases.

Management said KDIGO’s inclusion of nafamostat could help institutions develop their own CRRT anticoagulation protocols if the product receives approval. Aslam said the guidelines are widely known among U.S. healthcare professionals, although institutional adoption may vary.

Market Opportunity and Commercial Planning

Talphera updated its estimate of the U.S. CRRT market, projecting approximately 200,000 annual procedures in 2027, the anticipated timing of a potential nafamostat launch. That estimate is 21% higher than the company’s prior estimate of 165,000 procedures.

Angotti said Talphera expects the number of CRRT procedures to continue increasing annually and believes nafamostat could address unmet needs associated with systemic heparin and regional citrate. He said the market appears concentrated, with approximately 70 institutions representing more than half of the estimated procedure volume.

The company expects its initial commercial approach to focus on targeted accounts rather than a traditional broad sales-force rollout. Angotti said Talphera would likely employ account managers, educators and trainers, supported by peer-to-peer medical education.

Talphera expects initial hiring to begin after a PMA submission in the first half of 2027, with only a small number of early hires planned. The company also noted that CorMedix has a 60-day right of first negotiation following a data readout, which Angotti said remains a consideration as Talphera evaluates commercialization plans.

Talphera plans to hold an investor and analyst event closer to the expected completion of enrollment, likely in the fourth quarter, to discuss its market research and commercial approach. Management said it has conducted research on market sizing, disease-state segmentation, physician views on current treatment options and nursing workload related to CRRT anticoagulation.

Cash Position and Expenses

Asadorian reported cash of $17.1 million as of June 30, 2026. He said the company believes its cash balance, together with future conditional financing tranches, will provide sufficient capital through at least a potential NIYAD PMA approval expected in 2027.

Two conditional financing tranches remain available, totaling approximately $16 million, Talphera said. If their conditions are met, the company expects the tranches to close around the release of top-line data and the announcement of study completion.

Cash operating expenses, comprising research and development and selling, general and administrative expenses, totaled $3.9 million in the second quarter, compared with $3.7 million a year earlier. Excluding non-cash stock-based compensation, cash operating expenses were $3.7 million, up from $3.5 million in the prior-year quarter.

Asadorian attributed the $200,000 increase in cash operating expenses primarily to higher NIYAD development costs associated with increased enrollment and certain selling, general and administrative expenses tied to initial market research activities.

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.

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