Filana Therapeutics reports Q3 2026 financial results

Item 2.02. Results of Operations and Financial Condition.

On November 5, 2026, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information provided in this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section. Such information shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in such filing.

Item 9.01. Financial Statements and Exhibits.

Exhibit Number Description

99.1 Press Release dated November 5, 2026

104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.¹

Filana Therapeutics, Inc.

a Delaware corporation

Date: November 5, 2026 By: /s/ Eric J. Schoen

Eric J. Schoen

Chief Financial Officer

PRESS RELEASE EXHIBIT 99.1

Filana Therapeutics Reports Q3 2026 Financial Results and Provides Business Update

– Patient screening in Phase 2a study of simufilam in TSC-related epilepsy expected to begin by Q1 2027, following recent lift of FDA clinical hold

– Recent publication in Cells 1 provides new insights into simufilam's potential mechanism of action

AUSTIN, Texas, Nov. 05, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, "Filana Therapeutics", the "Company") today reported financial results for the third quarter ended September 30, 2026.

"Simufilam has the potential to make a meaningful difference for patients with TSC-related epilepsy. We began working toward activating clinical study sites as soon as FDA lifted the clinical hold in September. Patient screening is expected to begin by the first quarter of 2027," said Rick Barry, President and Chief Executive Officer of Filana Therapeutics. "We are encouraged by the excitement among leading clinical investigators and the TSC community for this upcoming study."

Clinical Development Update

FDA clinical hold lifted: In September 2026, the FDA lifted the clinical hold on Filana's investigational new drug (IND) application for simufilam in Tuberous Sclerosis Complex (TSC)-related epilepsy. Following this decision, the Company is advancing preparations for its planned Phase 2a study.

Phase 2a study preparations: The study is expected to enroll approximately 40 patients ages 12 to 55 at approximately 13 clinical sites in the United States. The randomized, double-blind study will evaluate two doses of simufilam, each administered in addition to standard of care therapy. The study consists of a four-week baseline assessment, a 16-week treatment period, and an optional 48-week extension. Patient screening is expected to begin by the first quarter of 2027.

Scientific Publications

New preclinical research published in Cells ˆ : The October publication by researchers at Yale School of Medicine provides additional insight into simufilam's potential mechanism of action. The study evaluated simufilam in TSC2-deficient human cells and identified effects on cellular stress-related signaling and mitochondrial function. These findings add to previously reported preclinical research supporting the investigation of simufilam in TSC-related epilepsy 2 ,3 .

Financial Results for Third Quarter 2026

Cash and cash equivalents at September 30, 2026 were $47.0 million.² The Company has no debt.

Research and development (R&D) expenses for the third quarter of 2026 were $3.9 million.³ This compared to $4.0 million for the same period in 2025.⁴ This 2% decrease was due primarily to decreases in preclinical and stock-based compensation expenses, partially offset by increased expenses preparing for the TSC-related epilepsy clinical program.

General and administrative (G&A) expenses for the third quarter of 2026 were $7.4 million. This compared to $7.9 million for the same period in 2025. The 6% decrease was due primarily to lower stock-based compensation expenses compared to the prior year period.

Net cash used in operations was $18.8 million during the first nine months of 2026.

Litigation Settlement Escrow Payment : On July 23, 2026, the Company transferred $31.25 million into escrow in connection with the potential settlement of certain securities litigation recorded in 2025. This payment is recorded as restricted cash on the consolidated balance sheets subject to a court approved disposition.

Net cash used in operations for second-half 2026 is expected to be in a range from $11 to $15 million. The Company estimates cash and cash equivalents at year-end 2026 in a range from $38 to $42 million.

Net loss for the third quarter of 2026 was $10.7 million, or $0.22 per share. This compares to a net loss of $10.8 million, or $0.22 per share, for the same period in 2025.

Shares outstanding were 50.3 million as of November 5, 2026.

About TSC and TSC-related Epilepsy

Tuberous Sclerosis Complex (TSC) is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2 gene. These mutations affect the mechanistic target of rapamycin (mTOR) pathway and can cause tumors to grow in multiple organs 4,5 . Epilepsy is the most common health issue affecting the TSC community, with 80% to 90% of TSC patients experiencing seizures 6 . TSC-related epilepsy affects approximately 45,000 people in the U.S. 2,4 Most patients start having seizures within their first year of life 2 . Even with multiple approved treatments, more than 60% of TSC patients remain refractory to antiepileptic therapy 7 .

About Filana Therapeutics, Inc.

Filana Therapeutics, Inc. (NASDAQ: FLNA), is a biotechnology company focused on developing novel, investigational therapies to modulate the filamin A protein for the treatment of central nervous system disorders, such as tuberous sclerosis complex (TSC)-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A.

For more information, please visit: https://www.FilanaTx.com

References:

Islam MM, Sokolov AM, Luo L, et al. Simufilam regulates mitochondrial function in HEK293T TSC2 knockout cells. Cells. 2026;15(20):1864. https://doi.org/10.3390/cells15201864 .

Zhang L, Huang T, Teaw S, Nguyen LH, Hsieh LS, Gong X, Burns LH, Bordey A. Filamin A inhibition reduces seizure activity in a mouse model of focal cortical malformations. Science Translational Medicine. 2020;12(531):eaa