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Filana Therapeutics (FLNA) investor relations material
Filana Therapeutics Q3 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Q3 net loss was $10.7M, versus $10.8M a year earlier; 9M net loss narrowed to $29.7M from $78.4M, primarily reflecting lower operating expenses after the Alzheimer’s program wind-down and lower prior-year legal charges.
FDA lifted the clinical hold on simufilam for TSC-related epilepsy in September 2026; Phase 2a patient screening is targeted by Q1 2027.
Financial highlights
Q3 operating expenses and operating loss were $11.3M, down from $11.9M; R&D was $3.9M versus $4.0M and G&A was $7.4M versus $7.9M.
9M operating expenses were $31.8M versus $81.8M; R&D was $11.7M versus $22.7M and G&A was $20.1M versus $59.1M.
9M net loss was $29.7M versus $78.4M, or $0.61 versus $1.62 per share; Q3 loss per share was $0.22 in both years.
No product revenue; 9M operating cash use was $18.8M versus $22.5M, and cash and cash equivalents were $47.0M at September 30, 2026, with no debt.
Outlook and guidance
Planned 16-week Phase 2a study in refractory TSC-related seizures targets ~40 patients ages 12–55 at ~13 U.S. sites; screening is expected by Q1 2027.
H2 2026 operating cash use was forecast at $11M–$15M, with year-end cash and cash equivalents estimated at $38M–$42M.
Near-term R&D spending for TSC-related epilepsy is expected to be significantly lower than for the former Alzheimer’s program; G&A is also expected to decrease.
Cash and cash equivalents are expected to fund operations for at least 12 months; future financing may be sought, with availability and terms uncertain.
- Simufilam advances as a first-in-class TSC epilepsy therapy, supported by strong data and financial stability.FLNA
Corporate presentation - Net loss narrowed as costs fell; simufilam’s TSC trial remains on FDA hold amid litigation settlement.FLNA
Q2 2026 - All proposals passed as the company focuses on resolving the FDA clinical hold for its TSC program.FLNA
AGM 2026 - Simufilam shows promise as a first-in-class TSC epilepsy therapy, with strong preclinical data and robust safety.FLNA
Corporate presentation - Net loss narrowed and expenses fell as focus shifted to TSC epilepsy, pending FDA review.FLNA
Q1 2026 - Key votes include director elections, equity plan expansion, and auditor ratification.FLNA
Proxy filing - 2025 loss widened on one-time items; focus shifts to TSC epilepsy with strong cash reserves.FLNA
Q4 2025 - Advancing simufilam for TSC-related epilepsy, targeting a large unmet need with strong preclinical data.FLNA
Investor presentation - Strategic shift to TSC epilepsy, phase II-A trial in 2026, strong safety and financials.FLNA
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