Filana Therapeutics (FLNA) investor relations material

Executive summary

• Focus shifted to simufilam for TSC-related epilepsy after discontinuing Alzheimer’s program in Q2 2025; all Alzheimer’s clinical trials were phased out following failed Phase 3 efficacy endpoints.

• Simufilam preclinical studies in TSC models showed reduced seizure activity; IND for clinical trial in TSC-related epilepsy is on full clinical hold pending additional data and protocol modifications; company is engaging with FDA to address the hold and maintain community engagement.

• Exclusive worldwide rights to Yale’s intellectual property for simufilam in TSC-related epilepsy secured in February 2025, with milestone and royalty obligations.

• Participated in major scientific conferences, published supporting preclinical data, and sponsored the 2026 TSC World Conference.

Financial highlights

• Net loss for Q2 2026 was $8.6 million ($0.18 per share), compared to $44.2 million ($0.92 per share) in Q2 2025; net loss for the first half of 2026 was $18.9 million, down from $67.6 million year-over-year.

• Research and development expenses decreased 35% to $3.3 million for Q2 2026 and 58% to $7.8 million for the first half, reflecting the phase out of Alzheimer’s program.

• General and administrative expenses dropped 85% to $6.1 million for Q2 2026 and 75% to $12.7 million for the first half, mainly due to absence of prior year’s $31.3 million litigation loss contingency.

• Cash and cash equivalents were $82.7 million as of June 30, 2026, down from $95.5 million at December 31, 2025; $31.25 million paid into escrow for litigation settlement after quarter-end.

• Net cash used in operations for H1 2026 was $12.7 million, below previous guidance.

Outlook and guidance

• Research and development expenses for TSC-related epilepsy expected to remain significantly lower than prior Alzheimer’s program.

• General and administrative expenses anticipated to decrease but remain elevated due to ongoing legal matters.

• Net cash used in operations for H2 2026 expected to be $11–15 million, plus $31.25 million for litigation settlement; estimated unrestricted cash at year-end 2026 projected at $36–40 million.

• Current cash position expected to fund operations for at least the next 12 months; additional financing may be sought but is not assured.

• Plans to resume clinical studies with simufilam in TSC-related epilepsy pending FDA approval.