Talphera outlines accelerated NEPHRO enrollment and lowers 2025 cash operating expense guidance amid protocol shift

Earnings Call Insights: Talphera, Inc. (TLPH) Q2 2025

MANAGEMENT VIEW

* Vincent J. Angotti, CEO, highlighted “the progress made this past quarter, specifically in the acceleration of the NEPHRO study enrollment” and detailed the impact of restructuring efforts, stating the reduction in the study size to 70 patients and the focus on new clinical site profiles. Angotti expressed confidence, noting “the number of total enrolled patients has more than doubled since May,” with strong engagement from new sites featuring nephrologist principal investigators and medical ICU settings.
* Angotti reported that “six additional new target profile sites... are expected to begin enrolling over the rest of this quarter,” supporting the plan to complete the study by year-end. He also identified interest from institutions for compassionate use of nafamostat, citing “continued shortages of citrate and potential supply chain issues with heparin.”
* Shakil Aslam, Chief Medical Officer, stated, “We now have a total of 7 sites that are actively screening,” and emphasized that 90% of enrolled patients to date came from new target profile sites. Aslam confirmed the termination of one legacy site for non-performance and projected “the study enrollment rate to accelerate further with the addition of the 6 new sites.”
* Raffi Mark Asadorian, CFO, provided a direct update: “we are reducing the previously communicated 2025 expected cash operating expense guidance to now be in the range of $16 million to $17 million.” He added, “Our cash operating expenses... for the second quarter of 2025 totaled $3.7 million compared to $4.3 million for the second quarter of 2024.”

OUTLOOK

* The company maintains its goal to complete the NEPHRO study by the end of 2025, with Angotti stating, “we're on plan to complete the study by the end of this year.”
* Guidance for 2025 cash operating expenses has been lowered to $16 million to $17 million, down from the prior range of $17 million to $19 million.
* No changes to the strategic focus or commercial expectations for Niyad were noted, with continued emphasis on market need and regulatory progress.

FINANCIAL RESULTS

* Cash operating expenses for Q2 2025 were reported as $3.7 million, compared to $4.3 million for the same period in 2024. Excluding noncash stock-based compensation, Q2 2025 expenses were $3.5 million versus $4 million in Q2 2024.
* Cash balance at June 30, 2025, stood at $6.8 million, reflecting the first tranche of recently closed financing. The remaining two tranches are tied to patient enrollment and stock price milestones.
* Asadorian identified that “the decrease in cash operating expenses in the second quarter of 2025 was primarily due to reductions in personnel expense and other general and administrative expenses.”

Q&A

* Antonio Eduardo Arce, WestPark Capital, asked about the acceleration needed to reach the 70-patient target. Angotti responded, “If you do the math, you look at the 9 sites that are going to come on board... we need a total of 55 patients. That's about 1.5 patients per site per month. Our current run rate in just the last 6 weeks is higher than that.”
* Arce inquired about leveraging compassionate use data for future publication and commercial use. Aslam explained that while not part of the efficacy dataset, “this dataset will be part of our submission for safety reasons. And obviously, this will be used as a publication.”
* James Francis Molloy, Alliance Global Partners, questioned supply chain issues and financing tranches. Angotti described supply chain instability as ongoing, stating users are “always on edge about the supply that they'll have and if it will be predictable or not.” Asadorian clarified that “the investors do have the right to waive” the stock price condition for financing tranches, with focus on patient enrollment milestones.
* Nazibur Rahman, Maxim Group, addressed new site activation speed and historical administrative issues. Aslam credited site selection and internal process improvements, stating, “we have very high level of confidence. By the end of this quarter, we will have all 9 sites... up and running and enrolling.”

SENTIMENT ANALYSIS

* Analysts’ tone was slightly positive, focusing on progress in enrollment, expense management, and practical challenges, while seeking clarity on logistics and financing.
* Management maintained a confident and upbeat tone, especially around the clinical strategy and operational execution. Angotti repeatedly referenced confidence in “completing the NEPHRO trial this year,” and Aslam described the new enrollment strategy as validated and successful.
* Compared to the previous quarter, both management and analysts displayed increased optimism, with less emphasis on site activation challenges and more on execution and progress. Management’s responses were more detailed and direct, indicating higher confidence.

QUARTER-OVER-QUARTER COMPARISON

* Guidance for 2025 cash operating expenses shifted down to a $16 million to $17 million range from $17 million to $19 million previously.
* The NEPHRO study’s momentum increased, with management now reporting a doubling of enrolled patients since May and a higher number of active and soon-to-be-activated new profile sites.
* Analysts’ focus moved from concerns over site activation and broader eligibility criteria to progress metrics, enrollment pace, and operational execution.
* Management’s confidence and specificity in their responses improved, with more granular details provided about the study’s mechanics and site performance compared to the previous quarter.

RISKS AND CONCERNS

* Supply chain reliability for heparin and citrate remains a challenge, with Angotti describing “well-documented set of historical challenges with the supply chain.”
* Financing for study completion is dependent on patient enrollment and stock price milestones, though investors may waive stock price conditions.
* The company continues to monitor and terminate underperforming legacy sites to maintain enrollment momentum.

FINAL TAKEAWAY

Talphera’s management emphasized the marked acceleration in NEPHRO study enrollment driven by a strategic shift to nephrology-focused, high-volume medical ICU sites. Cost discipline has resulted in a downward revision of 2025 cash operating expense guidance. The company maintains confidence in completing the NEPHRO trial by year-end, while continuing to navigate supply chain uncertainties and milestone-driven financing. Investors were given detailed insights into operational progress and the mitigation of legacy site challenges, reflecting a company increasingly focused on execution and commercial readiness.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/tlph/earnings/transcripts]

MORE ON TALPHERA

* Talphera, Inc. (TLPH) Q2 2025 Earnings Call Transcript [https://seekingalpha.com/article/4813901-talphera-inc-tlph-q2-2025-earnings-call-transcript]
* Seeking Alpha’s Quant Rating on Talphera [https://seekingalpha.com/symbol/TLPH/ratings/quant-ratings]
* Historical earnings data for Talphera [https://seekingalpha.com/symbol/TLPH/earnings]
* Financial information for Talphera [https://seekingalpha.com/symbol/TLPH/income-statement]