Talphera, Inc. Q1 FY2026 earnings call

• Clinical Study Progress

  • The NEFRO CRRT study for NIAID has well exceeded the 50% enrollment milestone achieved in early March 2026. Protocol adjustments adopted in 2025 and new target-profile clinical sites have accelerated enrollment, and management expects to complete full enrollment in 2026.
  • Of the 12 currently activated sites, 9 match the new target profile with nephrologists as lead investigators, and these sites have enrolled over 90% of study patients. All active sites are highly engaged, and the company will add 2 additional sites to reach the 14-site maximum allowed by the FDA. The new sites, one of which is among the top 5 U.S. hospitals for CRRT volume, will contribute to post-approval clinical awareness rather than significant enrollment.
  • Key opinion leaders confirm that currently available CRRT anticoagulants have meaningful disadvantages, and Nefamistat would fill a large unmet medical need in the U.S. market. Nefamistat has almost 40 years of use outside the U.S.

• Financial Operations

  • Cash and cash equivalents totaled $21.1 million as of March 31, 2026. The company closed a $4.1 million conditional financing tranche from its March 2025 private placement during Q1 2026. Two remaining conditional tranches totaling ~$16 million are available if study milestones are met, expected to close around top-line data release later this year.
  • Total cash operating expenses (combined R&D and SG&A) were $3.9 million in Q1 2026, up from $2.9 million in Q1 2025. Excluding non-cash stock-based compensation, cash operating expenses were $3.7 million in Q1 2026 vs $2.7 million in Q1 2025. The increase is driven by higher NIAID development costs tied to increased enrollment and higher general and administrative expenses.

• Clinical Protocol Feedback

  • Investigators and site staff report high satisfaction with the simplicity of NIAID study dosing and monitoring. ~70% of patients reach the target activated clotting time range on the initial starting dose, with most remaining patients requiring only one additional titration; all patients reach the target range within the first hour. Once stabilized, lab parameters remain consistently in range, with far less variability than seen with standard-of-care anticoagulants (heparin or citrate). This stability stems from Nefamistat not being dependent on kidney or liver function for metabolism, a key advantage for critically ill CRRT patients with fluctuating organ function.

Telferra is a clinical-stage biotech focused on the development of NIAID (Nefamistat) for anticoagulation in continuous renal replacement therapy (CRRT), and has no commercial product segments generating revenue as of Q1 2026. All operating spending is directed to clinical development and general corporate operations.

• Management reaffirms prior guidance that full enrollment of the NEFRO CRRT study will be completed in 2026, with top-line data readout expected in the second half of 2026.
  • Top-line data will be released within one month of last patient out, as the study uses short endpoints (24-hour primary, 72-hour secondary) and data cleansing is completed on an ongoing basis during enrollment.
  • Management expects current cash plus available conditional financing will provide sufficient capital to reach potential PMA approval of NIAID, targeted for 2027.
  • There are no planned interim enrollment updates (e.g., for 75% enrollment) prior to the announcement of full enrollment completion.

• Forward-looking statements regarding study completion timing, data release, PMA approval, and access to additional conditional financing are subject to inherent risks and uncertainties, per standard SEC disclosures. Specific risks cited or implied include slower-than-expected patient enrollment, failure to meet conditions for remaining financing tranches, potential failure of the study to meet clinical endpoints, and possible FDA non-approval of NIAID. No new material operational failures were disclosed on the call.

Q: Will the company provide an interim enrollment update for the 75% milestone, and is top-line data still on track for the second half of 2026? / A: Management does not plan to issue any additional interim enrollment updates, as no further financing tranches are tied to interim milestones. The company reaffirms guidance that full enrollment will be completed and top-line data released in the second half of 2026, and remains confident in meeting this timeline.

Q: What can you share about the two new upcoming study sites, and what feedback have you received from site staff about study progress? / A: The two new sites match the target profile of nephrologist-led sites, and one is among the top five U.S. hospitals for CRRT volume; their names will be published on ClinicalTrials.gov when the site list is updated. They joined late, so they will not contribute much to enrollment, but their participation builds clinical awareness for potential approval. Site staff, including principal investigators and nurses, have praised the simplicity of the dosing and titration protocol compared to existing anticoagulants.

Q: What feedback have you received on the stability of NIAID dosing, and how does current site standard of care compare for CRRT anticoagulation? / A: ~70% of patients hit the target clotting range on the first dose, and all reach the target within one hour. Parameters stay stable after titration because Nefamistat does not depend on kidney or liver function for metabolism, unlike heparin or citrate, which are affected by fluctuating organ function in critically ill patients. Most of the current 12 active sites do not use a consistent first-line anticoagulant for all CRRT patients; heparin or citrate are mostly used as rescue therapy for clotting, with only one site using heparin as standard of care and no sites using citrate as a first-line agent.