Transformative medicines for CNS disorders, starting with TSC-related epilepsy.
Filana’s lead program, simufilam, is an oral small molecule for TSC-related epilepsy, a rare disease in which more than 60% of patients remain refractory to antiepileptic therapy, per the company’s release. On Sep 22, 2026 the company announced that the FDA had lifted its clinical hold on the planned Phase 2a study, with sites identified and drug supply in place.
Cash, Jun 30, 2026$82.7M
Debt, per the Q2 2026 releaseNone
FDA clinical hold on the Phase 2aLifted, announced Sep 22, 2026
Figure 1. The Filana F drawn as a scaffold of cross-linked filaments. A schematic, not a scientific image. The company describes filamin A (FLNA), the protein simufilam is designed to modulate, as a scaffolding protein.
01
Summary
Filana at a glance
Each entry cites the filing it comes from. Periods are labelled by the date they end.
Issuer
Filana Therapeutics, Inc. (Nasdaq: FLNA), formerly Cassava Sciences, Inc. The legal name changed effective Mar 10, 2026 and the ticker changed to FLNA on Mar 11, 2026. 8-K, acc. 0001437749-26-007422
Simufilam, an oral small molecule, for tuberous sclerosis complex (TSC)-related epilepsy. A Phase 2a study is planned; on Sep 22, 2026 the company announced that the FDA had lifted its full clinical hold. 8-K, acc. 0001171843-26-006161
The company estimates unrestricted cash of $36M to $40M at year-end 2026, after second-half operating cash use of $11M to $15M and the $31.25M settlement funding. 8-K, acc. 0001171843-26-004982
Management “believes that the current working capital position will be sufficient to meet the Company’s working capital needs for at least the next 12 months.” 10-Q, acc. 0001437749-26-024752
Simufilam is a proprietary, investigational, orally administered small molecule. The company says it is believed to modulate the activity of the filamin A (FLNA) protein, which regulates diverse aspects of neuronal development.
2.2
The disease
TSC is a rare genetic disorder of the mTOR pathway caused by mutations in TSC1 or TSC2. Epilepsy is its most common health issue: 80% to 90% of people with TSC experience seizures, TSC-related epilepsy affects approximately 45,000 people in the US, and more than 60% remain refractory to antiepileptic therapy, per the company’s release.
2.3
Preclinical evidence
In a mouse model of focal onset seizures due to TSC-related pathology, work in Dr. Angélique Bordey’s lab at Yale found simufilam reduced seizure frequency by 60% against vehicle, treated before or after seizure onset. A study with the TSC Alliance Preclinical Consortium in Tsc1 conditional knockout mice found it attenuated the progression of seizure activity in a dose-dependent manner.
Mouse results may not predict results in patients. Source: company website (home page: 60%; pipeline page: 60-70%).
2.4
Earlier human data
The company cites legacy clinical data on simufilam: an elimination half-life of about 4.5 hours, with about 30% accumulation after 28 days of twice-daily dosing. The company labels these “legacy clinical data”; mechanism and clinical potential remain under investigation.
2.5
Focus today
The company’s current target is TSC-related epilepsy. Simufilam was previously studied in Phase 3 for Alzheimer’s disease; all ongoing Alzheimer’s trials were discontinued in 2024 and the phase-out was completed in the second quarter of 2025. 10-K, acc. 0001437749-26-007962
03
Next milestone · Phase 2a planned
The planned Phase 2a study, drawn to scale
A 16-week, multicenter, randomized, double-blind study of two doses of simufilam in patients with refractory TSC-related seizures, followed by a 48-week extension. Patient screening is expected to begin by the first quarter of 2027.
16 weeks16 wk
48 weeks
Week 0Week 16Week 64 if back to back
Double-blind treatment, 16 weeks. Two doses of simufilam in patients with refractory TSC-related seizures.
Extension study, 48 weeks. Open to all subjects who complete the double-blind treatment phase.
Blocks are drawn to scale: 16 weeks is one quarter of the 64 weeks shown. The 64 is this page’s sum of the two periods; the filing gives no total duration or start date for the extension, and no screening time before week 0, so none is drawn. Source: Form 8-K dated Sep 22, 2026, acc. 0001171843-26-006161.
Sites
13, in the US
Target enrollment
40 subjects aged 12 to 55
Population
Refractory TSC-related seizures
Assessed
Safety, tolerability, pharmacokinetics, and seizure measures: frequency, intensity and duration, nighttime seizures, sleep-related outcomes
The FDA path to the Phase 2a
FDA first notifies the company about its IND for a proof-of-concept trial.
FDA says it needs additional information to assess risk to human subjects.
FDA confirms a full clinical hold, asking for additional preclinical data and a modified protocol. The company no longer expects a first-half 2026 start.
The company announces that the FDA has lifted the full clinical hold. It has identified sites, is recruiting potential investigators, and has drug supply in place.
Sources: Forms 8-K dated Dec 3, 2025, Dec 18, 2025 and Sep 22, 2026. The company says data from this study are expected to help inform the development path, including future studies in younger patients. A planned study may change or not proceed.
04
Financials
Balance sheet and 2026 guidance
$82.7M in cash and no debt at Jun 30, 2026. Operating expenses for the six months ended Jun 30, 2026 were $20.6M, against $70.0M a year earlier, a period that included a $31.25M litigation loss contingency recorded in the second quarter of 2025. Sources: 10-Q and Q2 results release.
Cash and cash equivalents at each period end, $M
Dec 31, 2023$121.1M
Dec 31, 2024$128.6M
Dec 31, 2025$95.5M
Jun 30, 2026$82.7M
Bars start at zero and are drawn to scale. Sources: 10-K for FY2025 (Dec 2023 as the opening balance of its cash-flow statement, then Dec 2024 and Dec 2025) and 10-Q (Jun 2026).
From Jun 30 cash to the year-end guidance, $M
Cash, Jun 30, 2026$82.7M
Paid into escrow, Jul 23$31.25M
Operating use, second half$11M to $15M
Guided unrestricted cash, year-end$36M to $40M
Company guidance Net cash used in operations for the second half of 2026 is expected at $11M to $15M, plus the $31.25M settlement funding. The company estimates unrestricted cash at year-end 2026 of $36M to $40M.
Bars are to scale on a $0 to $90M axis. Where each step starts and ends is this page’s arithmetic from the company’s figures; the $31.25M is restricted until final court approval. Source: Q2 results release (8-K) and 10-Q.
Results of operations, $M, per the 10-K for the year ended Dec 31, 2025
Line
FY2025
FY2024
FY2023
Research and development
26.6
69.6
89.4
General and administrative
68.8
71.8
16.5
Total operating expenses
95.4
141.4
106.0
Operating loss
(95.4)
(141.4)
(106.0)
Interest income
4.6
8.5
7.8
Other income (loss), net
(0.2)
0.4
0.9
Gain from change in fair value of warrant liabilities
nil
108.2
nil
Net loss
(91.0)
(24.3)
(97.2)
Results of operations, $M, six months ended Jun 30, per the 10-Q
Line
2026
2025
Research and development
7.8
18.8
General and administrative
12.7
51.2
Total operating expenses
20.6
70.0
Operating loss
(20.6)
(70.0)
Interest income
1.5
2.5
Other income (loss), net
0.1
(0.1)
Net loss
(18.9)
(67.6)
Sources: 10-K acc. 0001437749-26-007962; 10-Q acc. 0001437749-26-024752. Figures are rounded to $0.1M, so columns may not sum exactly. The 2024 net loss is after a non-cash $108.2M gain from the change in fair value of warrant liabilities. General and administrative expense in 2025 includes a $31.25M securities litigation loss contingency recorded in the second quarter of 2025.
05
Filings
Recent filings, newest first
Each entry links to its SEC EDGAR filing index. Labels describe the filing’s items; they are not company headlines. Company press releases are on the official site.
This page is a concept and does not collect email or run alerts. Email alerts for filings and press releases, and the investor-relations question form, are on Filana’s own site.
Material risks, legal matters and listing status, in the company’s own filed words.
“On July 23, 2026, the Company paid into escrow $31.25 million as required by the Stipulation.”
Note 10, Contingencies, Form 10-Q for the quarter ended Jun 30, 2026
Securities class action
Four putative class actions filed in Aug to Oct 2021 were consolidated in Texas federal court, for purchasers of the company’s securities between Sep 14, 2020 and Oct 12, 2023. A binding term sheet was reached in Dec 2025, and on Jun 18, 2026 a stipulation of settlement and a motion for preliminary approval were filed: $31.25M to settle all claims, with no admission of fault. The 10-Q reports no ruling yet. The money is in escrow, restricted until final court approval. The amount was already accrued as a loss contingency at Dec 31, 2025.
Shareholder derivative actions
Several derivative suits were filed from Nov 2021. On Jul 21, 2026 the company and all individual defendants signed a settlement term sheet to resolve them, including four years of corporate governance enhancements. The 10-Q says the parties agreed to work toward a final stipulation within 60 days of the term sheet, subject to board and court approval.
SEC
On Sep 26, 2024 the company announced a settlement of the SEC investigation of its disclosures about its Phase 2b Alzheimer’s study. It neither admitted nor denied the allegations, consented to a permanent injunction, and paid a $40 million civil penalty in Nov 2024. Final consent judgment was entered Oct 18, 2024.
Department of Justice
The indictment of Dr. Hoau-Yan Wang, a former scientific collaborator, was dismissed with prejudice on Oct 23, 2025, and the DOJ Fraud Section told the company on Feb 18, 2026 that it had closed its inquiry. The company is aware that the DOJ Civil Division continues to seek information concerning the research and development of simufilam and SavaDx.
Nasdaq minimum bid price
On Sep 17, 2026 Nasdaq notified the company that its bid price had closed below $1.00 for 30 consecutive business days. The stock keeps trading. The company has until Mar 16, 2027 to close at $1.00 or more for at least ten consecutive business days, and may qualify for a second 180-day period; otherwise Nasdaq would notify it of a delisting determination, which it could appeal to a hearings panel.
The 10-Q raises no going-concern doubt and says management believes working capital is sufficient for at least the next 12 months. The release guides unrestricted cash to $36M to $40M at year-end 2026, from $82.7M at Jun 30, after the $31.25M settlement funding and second-half operating use. The company has no product revenue.
