Filana Therapeutics — Q3 2026 Earnings Summary

Financial Performance:

• Net loss for the third quarter of 2026 was $10.7 million ($0.22 per share), compared to $10.8 million ($0.22 per share) in the same period of 2025.
• Research and development expenses were $3.9 million for Q3 2026, a 2% decrease from $4.0 million in Q3 2025, driven by lower preclinical and stock-based compensation expenses partially offset by increased costs for the TSC-related epilepsy clinical program.
• General and administrative expenses were $7.4 million for Q3 2026, a 6% decrease from $7.9 million in Q3 2025, primarily due to lower stock-based compensation.
• Net cash used in operations was $18.8 million for the first nine months of 2026.
• Cash and cash equivalents were $47.0 million as of September 30, 2026.
• The Company has no debt.
• Restricted cash of $31.25 million was recorded on the balance sheet as of September 30, 2026, representing an escrow payment for potential securities litigation settlement.
• Total operating expenses for the nine months ended September 30, 2026, were $31.8 million, compared to $81.8 million in the prior year period.
• Net loss for the nine months ended September 30, 2026, was $29.7 million ($0.61 per share), compared to $78.4 million ($1.62 per share) in the same period of 2025.

Guidance and Future Outlook:

• Net cash used in operations for the second half of 2026 is expected to range from $11 million to $15 million.
• Cash and cash equivalents at year-end 2026 are estimated to range from $38 million to $42 million.
• Patient screening for the Phase 2a study of simufilam in TSC-related epilepsy is expected to begin by the first quarter of 2027.

Business Segments and Product Lines:

• The FDA lifted the clinical hold on the investigational new drug application for simufilam in TSC-related epilepsy in September 2026.
• The planned Phase 2a study will enroll approximately 40 patients aged 12 to 55 at roughly 13 clinical sites in the United States.
• The Phase 2a study design includes a four-week baseline assessment, a 16-week treatment period, and an optional 48-week extension, evaluating two doses of simufilam in addition to standard of care.
• A new preclinical study published in Cells by Yale School of Medicine researchers provided insights into simufilam's mechanism of action, identifying effects on cellular stress-related signaling and mitochondrial function in TSC2-deficient human cells.

Risks and Challenges:

• The Company faces risks related to its ability to initiate, enroll, conduct, and complete the planned Phase 2a study, including engaging clinical trial sites and participants.
• Potential risks include changes to clinical trial protocols, design, endpoints, timing, or patient populations.
• There is a risk that the Company may not generate clinical data supporting further development of simufilam.
• The resolution of securities litigation remains a contingency, with $31.25 million currently held in escrow.
• Drug discovery and development involve high risks, including the possibility of total loss of invested capital, as no product candidates are currently approved for sale.

Management Commentary and Tone:

• Rick Barry, President and CEO, stated that simufilam has the potential to make a meaningful difference for patients with TSC-related epilepsy and expressed encouragement regarding the excitement among clinical investigators and the TSC community.
• Management indicated they began working to activate clinical study sites immediately following the FDA's decision to lift the clinical hold in September.

Other Key Points:

• Shares outstanding were 50.3 million as of November 5, 2026.
• The Company is focused on developing therapies to modulate the filamin A protein for central nervous system disorders, specifically TSC-related epilepsy.
• TSC-related epilepsy affects approximately 45,000 people in the U.S., with 80% to 90% of TSC patients experiencing seizures and more than 60% remaining refractory to existing antiepileptic therapy.