Talphera (TLPH) Q3 2024 earnings summary

Executive summary

• NEPHRO CRRT registrational trial for nafamostat is progressing, with five active clinical sites and plans to expand to up to 14 as allowed by the FDA, targeting completion in 2025.

• Niyad, the lead candidate, has FDA Breakthrough Device Designation and is being evaluated as a regional anticoagulant in dialysis circuits.

• Initiatives to improve patient enrollment include automated notifications and EMR-based identification, with additional high-volume sites prioritized.

• Strong physician feedback and clinician engagement confirm the unmet need for alternative anticoagulants in CRRT.

• The company divested DSUVIA in 2023 and monetized future DSUVIA payments via an $8M agreement with XOMA in January 2024.

Financial highlights

• Q3 2024 net loss was $3.4 million, with cash operating expenses (R&D and SG&A, excluding stock-based compensation) at $3.5 million, up from $3 million year-over-year.

• Year-to-date cash operating expenses reached $11.5 million, with full-year 2024 guidance of $15–$17 million depending on Q4 enrollment rates.

• Cash, cash equivalents, and investments totaled $11.1 million at Q3 end, with additional capital likely needed within 12 months.

• Net loss per share from continuing operations was $0.13 for Q3 2024.

• Cash used in operating activities was $10.4 million for the nine months ended September 30, 2024.

Outlook and guidance

• Full-year 2024 cash operating expenses are projected at $15–$17 million, contingent on clinical enrollment pace.

• Management expects to need additional capital before November 2025 to fund planned operations.

• Study completion and data readout for NEPHRO CRRT are targeted for 2025, with rapid PMA submission expected post-trial.

• Additional clinical sites, especially high-volume medical ICUs, are being prioritized to accelerate enrollment.

• The company is also evaluating timing for NDA submissions for pre-filled syringe products.