Filana Therapeutics FLNA

NASDAQ FLNA

$0.69 +0.01 (+0.95%)

At close: Oct 20, 2026 · 4:00 PM EDT

Filana Therapeutics (FLNA) stock price is $0.69, up 0.95% on the day, as of Oct 20, 2026. It has a market cap of $33.61Mn, and is classified in the Biotechnology industry (Healthcare sector).

Key Stats

Market Cap33.61 Mn

P/E-0.79

P/S9.14

Div. Yield0.00

Revenue Growth (1y) (Qtr)-38.47

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About

Filana Therapeutics, Inc. is a clinical-stage biotechnology company headquartered in Austin, Texas that focuses on developing transformative medicines for central nervous system disorders linked to dysregulation or overexpression of the filamin A protein. The company’s lead product candidate, simufilam, is a proprietary small‑molecule oral therapy designed to modulate filamin A activity and is currently being investigated for the treatment of Tuberous Sclerosis Complex‑related epilepsy after the discontinuation of its Alzheimer’s disease program in mid-2025. Prior to that discontinuation, simufilam had been evaluated in two Phase 3 Alzheimer’s studies (RETHINK‑ALZ and REFOCUS‑ALZ) involving a total of approximately 1,900 patients and in a 24‑month Phase 2 safety study enrolling over 200 participants. The drug’s mechanism is based on preclinical findings that simufilam reduces seizure activity and limits neuronal abnormalities in mouse models of TSC‑related epilepsy and focal cortical dysplasia type II, effects comparable to genetic knockdown of filamin A. In December 2025 the company submitted an Investigational New Drug application for simufilam in TSC‑related epilepsy, which the FDA placed on a full clinical hold pending additional preclinical data and protocol revisions, and the company is working to address the hold’s requirements.

Filana Therapeutics does not generate revenue from product sales because it has no approved therapeutics; its income is derived mainly from research grants and collaborative agreements. The company has received funding from the National Institutes of Health to support clinical safety studies of simufilam, although the specific award amounts are not disclosed in the filing. In February 2025 it entered into a license agreement with Yale University that obligates it to pay milestone payments of up to $4.5 million upon achievement of clinical, regulatory and commercial milestones and tiered royalties ranging from a low- to mid-single-digit percentage on any future net sales of licensed products. Until a product obtains regulatory approval, the company’s cash inflows are limited to such grant income and any potential milestone receipts, while its expenditures are reflected in research and development costs of $26.6 million for the year ended December 31, 2025, $69.6 million for 2024 and $89.4 million for 2023. The firm employs 17 full-time staff members and three employees who devote a portion of their professional time to the company as of the end of 2025, and it relies entirely on third‑party vendors for manufacturing, with simufilam supplied by Evonik Industries AG under a drug supply agreement.

Within the biotechnology sector, Filana Therapeutics occupies an early‑stage niche focused on novel central nervous system therapies, competing against larger pharmaceutical companies that market established treatments for TSC‑related epilepsy such as Afinitor Disperz (everolimus) and Epidiolex (cannabidiol), as well as numerous biotech firms pursuing similar molecular targets. The company’s competitive advantages stem from its exclusive worldwide rights to simufilam through a robust patent portfolio—including nine issued U. S. patents with expiration dates ranging from 2029 to 2040—and the Yale license, which together cover composition of matter and methods of use in the United States, Europe, Australia, Israel, Canada and Japan. In addition to owned patents, Filana Therapeutics holds pending patent applications for diagnostic assets related to simufilam in the United States, Europe, Japan, China, Canada and Australia. The exclusive license grants the right to sublicense the licensed intellectual property and includes customary diligence obligations, milestone payments and royalties. Simufilam represents a potential first‑in‑class filamin A‑modulating agent, a mechanism supported by preclinical data showing seizure reduction in mouse models of TSC‑related epilepsy and focal cortical dysplasia type II, and the company continues to explore other indications where its preclinical experiments suggest a benefit.

The company’s customer base consists primarily of patients with central nervous system disorders, especially those suffering from TSC‑related epilepsy who are enrolled in its clinical trials. Filana Therapeutics collaborates with academic institutions such as Yale School of Medicine, patient advocacy groups including the Tuberous Sclerosis Alliance, and contract research organizations like PsychoGenics, which conducted the preclinical Tsc1‑CKO mouse study that evaluated simufilam’s effect on seizure progression. Manufacturing of simufilam is outsourced to Evonik Industries AG, a contract development and manufacturing organization that supplies clinical‑grade quantities of the drug substance for trial use. The company has also worked with clinical sites across the United States; its Phase 2 Alzheimer’s safety study enrolled participants from 16 U. S. clinical sites, and its planned TSC‑related epilepsy trial would similarly rely on a network of investigators and trial centers. These partners, trial sites and suppliers constitute the primary recipients of the company’s research, development and operational activities.

Investment Thesis

▲ Bull case

Cassava Sciences Inc (SAVA) may be undervalued by the market following the conclusion of both the U.S. Department of Justice and Securities and Exchange Commission investigations into its prior Alzheimer's drug development efforts, removing a significant overhang of regulatory and legal uncertainty that has weighed on the stock for an extended period. With these probes now closed and no further enforcement actions anticipated, the company is positioned to redirect focus and capital toward its new pipeline initiative—developing simufilam for tuberous sclerosis complex-related epilepsy, a rare genetic disorder with high unmet medical need and potential for orphan drug designation, which could provide accelerated development pathways and market exclusivity. The shift to a rare disease indication represents a structural pivot away from the highly competitive and historically unsuccessful Alzheimer's space, where failure rates exceed 99%, into a niche therapeutic area where clinical success is more attainable and commercial viability can be achieved with smaller patient populations, reducing commercialization risk and potentially improving investor sentiment as progress milestones are met. Furthermore, the elimination of legal distractions may allow management to operate with greater transparency and focus, potentially rebuilding credibility with investors and partners, which could be critical for securing future funding or strategic collaborations necessary to advance the new indication through clinical development.

▼ Bear case

Cassava Sciences Inc (SAVA) continues to face substantial fundamental risks despite the closure of regulatory investigations, as the company has yet to demonstrate any clinical efficacy for simufilam in its new target indication of tuberous sclerosis complex-related epilepsy, and there is no publicly available data from preclinical or early-stage trials to support the viability of this pivot, leaving investors to speculate on a hypothesis that has already failed in a larger, more well-funded indications program. The company’s history of SEC charges related to misleading clinical trial representations raises ongoing concerns about the reliability of its scientific disclosures and internal controls, suggesting that even if future data were released, market participants may remain skeptical of its validity, particularly given the lack of independent verification or publication in peer-reviewed journals to date. Furthermore, the rare epilepsy market, while offering orphan drug incentives, is limited in size and dominated by established therapies, meaning that commercial success would require not only proof of efficacy but also demonstration of meaningful differentiation in safety or effectiveness—a high bar given the failure of simufilam in Alzheimer’s trials despite extensive development. Without near-term catalysts such as clinical trial initiation, data readouts, or partnership announcements, the stock remains vulnerable to continued skepticism and low trading liquidity, with the market likely assigning minimal probability to a successful turnaround, especially considering the company’s depleted credibility and the high attrition rates inherent in CNS drug development.

Peer percentiles

How Filana Therapeutics ranks

Ranked against the 673 companies in Pharmaceuticals and Biotechnology58 metrics · as of Oct 16, 2026

Valuation

12 metrics · Lower multiples rank higher; a negative multiple ranks last

P/ENegative earnings −0.87xMedian 17.3x 23^rd
P/FCFNegative free cash flow −1.25xMedian 17.9x 23^rd
P/Operating cash flowNegative operating cash flow −1.28xMedian 16.4x 22^nd
P/S 9.98xMedian 9.48x 49^th
P/B 0.58xMedian 2.17x 86^th
P/Tangible book 0.58xMedian 2.41x 87^th
EV/EBITDANet cash exceeds market value 1.02xMedian 16.1x Not meaningful —
EV/EBITNet cash exceeds market value 1.00xMedian 19.7x Not meaningful —
EV/RevenueNet cash exceeds market value −12.5xMedian 6.87x Not meaningful —
EV/FCFNet cash exceeds market value 1.57xMedian 19.3x Not meaningful —
EV/Operating cash flowNet cash exceeds market value 1.60xMedian 16.2x Not meaningful —
PEG (3Y EPS CAGR)Negative earnings −0.03Median 0.35 Not meaningful —

Growth

14 metrics · Year-on-year growth and three-year compound annual growth

Revenue growth (1Y) −46.7%Median 10.1% 17^th
Revenue CAGR (3Y) −18.0%Median 10.1% 20^th
Gross profit growth (1Y) —Median 10.6% No data —
Gross profit CAGR (3Y) —Median 10.7% No data —
Operating income growth (1Y) 64.7%Median −0.5% 91^st
Operating income CAGR (3Y) 22.2%Median 1.5% 75^th
Net income growth (1Y) 65.7%Median −6.1% 88^th
Net income CAGR (3Y) 22.3%Median −1.2% 77^th
EPS growth (1Y) 65.7%Median 20.8% 76^th
EPS CAGR (3Y) 25.9%Median 25.2% 51^st
Operating cash flow growth (1Y) 70.0%Median 0.0% 91^st
Operating cash flow CAGR (3Y) 27.7%Median 2.4% 80^th
Free cash flow growth (1Y) 69.4%Median 0.0% 91^st
Free cash flow CAGR (3Y) 27.6%Median 3.2% 80^th

Profitability

14 metrics · Margins, returns on capital and the quality of earnings

Gross margin —Median 73.3% No data —
EBITDA margin −1,222%Median −223% 28^th
Operating margin −1,250%Median −238% 29^th
Pretax margin −1,250%Median −229% 29^th
Net margin −1,150%Median −233% 30^th
FCF margin −797%Median −174% 30^th
Operating cash flow margin −781%Median −170% 30^th
Return on equity −69.8%Median −54.1% 42^nd
Return on assets −43.3%Median −42.2% 49^th
Return on invested capital —Median −5.3% No data —
Return on capital employed −69.7%Median −46.5% 35^th
Asset turnover 0.03xMedian 0.18x 27^th
Cash conversion (OCF / net income)Net income is not positive 0.68xMedian 1.20x Not meaningful —
Stock comp / revenue 487%Median 27.7% 15^th

Financial Health

11 metrics · Leverage, liquidity and solvency; less debt ranks higher

Debt / assets —Median 20.0% No data —
Debt / equity —Median 0.26x No data —
Net debt / EBITDA —Median 1.82x No data —
Debt / FCF —Median 3.03x No data —
Liabilities / assets 38.8%Median 32.8% 46^th
Equity / assets 61.2%Median 67.2% 46^th
Interest coverage —Median −10.2x No data —
Current ratio 2.08xMedian 4.47x 29^th
Quick ratio 2.06xMedian 3.69x 35^th
Cash ratio 2.06xMedian 3.33x 40^th
Altman Z-score −7.31Median −0.74 25^th

Peer group

Peer Comparison

Companies in the Biotechnology

View all peers

S.No.	Ticker	Company	Market Cap	P/E	P/S	Total Debt (Qtr)
1	LLY	ELI LILLY & Co	1,146.94 Bn	42.94	14.40	54.91 Bn
2	JNJ	Johnson & Johnson	624.96 Bn	29.71	6.38	49.04 Bn
3	ABBV	AbbVie Inc.	510.15 Bn	80.85	7.92	70.82 Bn
4	MRK	Merck & Co., Inc.	366.13 Bn	115.39	5.50	53.91 Bn
5	NVS	Novartis Ag	297.75 Bn	18.87	5.44	9.59 Bn
6	AZN	Astrazeneca Plc	261.93 Bn	25.08	4.46	32.35 Bn
7	AMGN	Amgen Inc	236.51 Bn	27.05	6.21	57.30 Bn
8	FLNA	Filana Therapeutics, Inc.	0.03 Bn	-0.79	9.14	-

Filana Therapeutics FLNA

About

Investment Thesis

How Filana Therapeutics ranks

Valuation

Growth

Profitability

Financial Health

Shareholder Returns

Peer Comparison

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