Every 8-K that Filana Therapeutics, Inc. (FLNA) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow FLNA and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full FLNA filings page.
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. 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.
Filana Therapeutics reported Q1 2026 results showing sharply lower expenses and a smaller loss as it pivots to TSC-related epilepsy. Net loss was $10.3 million, or $0.21 per share, versus $23.4 million, or $0.48, a year earlier.
Research and development spending fell to $4.5 million from $13.7 million, a 67% decrease driven by phasing out the Alzheimer’s program. General and administrative costs declined to $6.6 million from $10.9 million, partly because a $3.0 million legal loss contingency booked in Q1 2025 did not recur.
Cash and cash equivalents were $86.6 million at March 31, 2026, with no debt, and the company estimates cash at June 30, 2026 in a range of $47–$50 million. Guidance includes net cash used in operations of $14–$17 million for first-half 2026 plus an expected $31.25 million loss contingency payment related to potential settlement of certain securities litigation.
Filana Therapeutics, Inc. reported that board member Michael O’Donnell has decided to resign from its Board of Directors, effective at the conclusion of the Company’s 2026 annual meeting of stockholders. He will continue to serve as a director until that meeting is completed.
The Company stated that Mr. O’Donnell’s resignation is not due to any disagreement with Filana Therapeutics, its management, or the Board regarding operations, policies, or practices. The report was signed on behalf of the Company by Chief Financial Officer Eric J. Schoen.