Filana Therapeutics filings document a development-stage biotechnology issuer focused on simufilam and TSC-related epilepsy. Recent 8-K reports include operating and financial updates, business-update materials, and material corporate events tied to the company’s research program and public-company status.
Proxy materials describe governance, board matters, executive compensation, equity awards, shareholder voting items, and annual-meeting procedures. The filing record also reflects the company’s renamed public identity, Nasdaq-listed FLNA security, and regulatory and business risks associated with drug discovery, preclinical work, clinical-development planning, and FDA interactions.
Filana Therapeutics, Inc. reported a third-quarter 2026 net loss of $10.7 million, compared with $10.8 million a year earlier. Nine-month net loss was $29.7 million versus $78.4 million, while research and development expense was $11.7 million versus $22.7 million, reflecting completion of the Alzheimer’s program phase-out in the second quarter of 2025.
The FDA lifted the full clinical hold on simufilam’s planned Phase 2a study in TSC-related epilepsy on September 22, 2026. The planned trial is 16 weeks, randomized and double-blind, targeting 40 participants at 13 U.S. sites; screening is expected to begin by the first quarter of 2027.
Cash and cash equivalents were $47.0 million at September 30, 2026; $31.25 million was restricted in escrow for a settlement subject to court approval and unavailable for general operations. Nine-month operating cash use was $18.8 million, compared with $22.5 million. During the quarter, the at-the-market program sold 1,760,000 shares at a weighted-average $1.16, generating approximately $2.0 million gross and $1.6 million net; approximately $48 million remained available. Nasdaq’s initial compliance period for the $1.00 minimum bid-price requirement runs through March 16, 2027.
Filana Therapeutics, Inc. (FLNA) reported Q3 2026 net loss of $10.7 million, or $0.22 per share, versus $10.8 million and $0.22 per share a year earlier. R&D expense was $3.9 million versus $4.0 million; G&A expense was $7.4 million versus $7.9 million. Cash and cash equivalents were $47.0 million at September 30, 2026, and Filana reported no debt.
The FDA lifted the clinical hold on simufilam for TSC-related epilepsy in September 2026. Patient screening in the planned Phase 2a study is expected by the first quarter of 2027; approximately 40 patients ages 12 to 55 are expected at approximately 13 U.S. sites. The randomized, double-blind study will evaluate two doses in addition to standard-of-care therapy, with a four-week baseline, 16-week treatment period and optional 48-week extension.
Operating cash use was $18.8 million for the first nine months of 2026; Filana expects $11 million to $15 million of operating cash use in the second half and year-end cash of $38 million to $42 million. On July 23, 2026, it transferred $31.25 million into escrow in connection with a potential settlement of certain securities litigation recorded in 2025; the amount is recorded as restricted cash subject to a court-approved disposition.
Filana Therapeutics, Inc. (FLNA) reported that the Fifth Circuit vacated the Texas District Court’s order granting class certification in the securities class action against the company and certain named officers and employees. The certified class had covered purchasers or acquirers of Filana securities between September 14, 2020, and October 12, 2023.
The Fifth Circuit concluded that the district court misapplied the applicable legal standard, but made no judgment about whether Filana securities traded in an efficient or inefficient market. Further class-certification proceedings will proceed on remand in the Texas District Court.
Filana Therapeutics, Inc. (FLNA) President & CEO Richard Barry reported two purchases of common stock held indirectly by trust: 206,813 shares on September 29, 2026, at a $0.90 weighted average price, and 100,000 shares on September 30, 2026, at a $0.92 weighted average price. The respective open-market purchase ranges were $0.86–$0.94 and $0.91–$0.93 per share. No Rule 10b5-1 plan is reported.
Filana Therapeutics, Inc. (FLNA) President & CEO Barry Richard reported an indirect purchase through a trust of 93,091 common shares on September 28, 2026. The shares were bought in multiple open market transactions at a weighted average price of $0.84 per share, within a range of $0.82 to $0.85. The reported post-transaction position was 1,031,151 shares held indirectly through a trust. No Rule 10b5-1 plan is reported.
Filana Therapeutics, Inc. (FLNA) reports that the U.S. FDA has lifted the full clinical hold on its investigational new drug application for simufilam, allowing a planned Phase 2a proof-of-concept study in TSC-related epilepsy to proceed. During the hold, Filana lined up a leading CRO, identified U.S. trial sites, and recruited potential investigators, with drug supply in place.
The 16-week multicenter, randomized, double-blind study will test two doses of simufilam in about 40 patients aged 12 to 55 with refractory TSC-related seizures at 13 U.S. sites, followed by a 48-week extension for completers. Endpoints focus on safety, tolerability, pharmacokinetics, and seizure-related outcomes, with data expected to guide further development, including potential studies in younger patients.
Filana Therapeutics, Inc. (FLNA) reports that Nasdaq has notified the company it is not in compliance with the $1.00 minimum bid price requirement for continued listing on the Nasdaq Capital Market because its common stock closed below $1.00 for 30 consecutive business days.
The shares continue to trade on Nasdaq under “FLNA.” Filana has 180 calendar days, until March 16, 2027, to regain compliance by having a closing bid of at least $1.00 for at least 10 consecutive business days. If it still fails to comply, it may receive an additional 180-day period or face a delisting determination, which the company could appeal. Filana states it will monitor its stock price and may consider available options to regain compliance, but there is no assurance it will maintain its Nasdaq listing.
Filana Therapeutics, Inc., a clinical‑stage CNS biotech, reported a net loss of $8.6 million for Q2 2026 and $18.9 million for the six months ended June 30, 2026, lower than the prior‑year periods as research and development and general and administrative expenses declined.
Cash and cash equivalents were $82.7 million at June 30, 2026, with total assets of $103.9 million and stockholders’ equity of $63.6 million; management believes current working capital will meet needs for at least the next 12 months. The company has no product revenue and an accumulated deficit of $515.0 million.
Development is centered on lead candidate simufilam for TSC‑related epilepsy, but the related IND is on full clinical hold pending additional data and protocol changes. Legal matters remain significant, including a previously paid $40 million SEC civil penalty and a proposed $31.25 million securities class‑action settlement that has been accrued and funded into escrow, contributing to $32.75 million of litigation reserves.
Filana Therapeutics, Inc. reported second quarter 2026 results and a business update focused on its simufilam program for TSC-related epilepsy. The company continues to work with the FDA to address information requests related to the full clinical hold on its proof-of-concept trial and is maintaining engagement with the TSC community, including sponsoring the 2026 TSC World Conference.
Cash and cash equivalents were $82.7 million at June 30, 2026, with no debt, and net cash used in operations in the first half of 2026 was $12.7 million, described as below prior guidance. R&D expense for the quarter was $3.3 million and G&A expense was $6.1 million, both lower than the prior year due to the completed phase-out of the Alzheimer’s disease program and the absence of a $31.25 million securities litigation loss contingency recorded in 2025.
Net loss for the quarter was $8.6 million, or $0.18 per share, compared with a net loss of $44.2 million, or $0.92 per share, a year earlier. On July 23, 2026, Filana funded $31.25 million into escrow toward potential settlement of certain securities litigation; this cash will remain restricted. The company projects second-half 2026 operating cash use of $11 to $15 million plus the litigation funding and estimates unrestricted year-end 2026 cash of $36 to $40 million. Shares outstanding were 48.3 million as of July 27, 2026.
Filana Therapeutics, Inc. held its 2026 Annual Meeting of Stockholders on June 11, 2026, where a quorum was reached with 24,559,776 shares present out of 48,307,896 entitled to vote, or approximately 51%.
Stockholders elected three directors to three-year terms, approved Amendment No. 2 to the 2018 Omnibus Incentive Plan, and ratified Ernst & Young LLP as independent auditor for the fiscal year ending December 31, 2026. They also approved 2025 executive compensation in a non-binding advisory vote, confirming the company’s pay practices while maintaining the existing board and governance structure.