Filana Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results

Rhea-AI Summary

Filana Therapeutics (NASDAQ: FLNA) reported 2025 results and a business update focused on its TSC-related epilepsy program and capital efficiency.

The company posted a net loss of $91.0 million ($1.88 per share) for 2025, year-end cash of $95.5 million and estimates cash of $47–$50 million at June 30, 2026. Filana is addressing FDA requests tied to a December 2025 clinical hold and expects to submit a response as soon as practicable.

Positive

• Year-end cash of $95.5 million with no debt
• R&D expenses decreased 62% to $26.6 million in 2025
• Company estimates cash $47–$50M at June 30, 2026

Negative

• Net loss widened to $91.0 million in 2025 from $24.3 million in 2024
• Cash declined from $128.6M at 12/31/2024 to $95.5M at 12/31/2025
• $31.25M estimated loss contingency payment related to securities litigation recorded for 2026

News Market Reaction – FLNA

-6.70%

3 alerts

-6.70% News Effect

+5.4% Peak Tracked

-$7M Valuation Impact

$100M Market Cap

0.8x Rel. Volume

On the day this news was published, FLNA declined 6.70%, reflecting a notable negative market reaction. Argus tracked a peak move of +5.4% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $7M from the company's valuation, bringing the market cap to $100M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Net loss 2025: $91.0 million Net loss 2024: $24.3 million Net loss per share 2025: $1.88 per share +5 more

8 metrics

Net loss 2025 $91.0 million Year ended December 31, 2025

Net loss 2024 $24.3 million Year ended December 31, 2024

Net loss per share 2025 $1.88 per share Year ended December 31, 2025

Cash and equivalents $95.5 million As of December 31, 2025; no debt

Net cash used in operations $32.3 million Full year 2025, consistent with guidance

Estimated cash $47–$50 million Estimated range at June 30, 2026

Estimated H1 2026 cash use $14–$17 million Estimated net cash use in operations, H1 2026

Litigation payment $31.25 million Estimated loss contingency for potential securities litigation settlement

Market Reality Check

Price: $1.99 Vol: Volume 757,213 is in line...

normal vol

$1.99 Last Close

Volume Volume 757,213 is in line with the 20-day average of 758,569. normal

Technical Shares at $2.09, trading slightly below the 200-day MA of $2.09, and 7.79% below the 52-week high.

Market Pulse Summary

The stock moved -6.7% in the session following this news. A negative reaction despite the company me...

Analysis

The stock moved -6.7% in the session following this news. A negative reaction despite the company meeting cash guidance and holding $95.5 million with no debt would reflect concern over the step-up in net loss to $91.0 million and sizable litigation-related contingencies, including a $31.25 million estimated payment. Investors may also weigh the transition away from the Alzheimer’s program against the costs and timing of advancing the TSC-related epilepsy program.

Key Terms

clinical hold letter, warrant liabilities, stock-based compensation, loss contingency

4 terms

clinical hold letter regulatory

"addressing FDA’s request for information detailed in the Clinical Hold Letter received in December 2025"

A clinical hold letter is an official notice from a regulatory authority that pauses a planned or ongoing clinical trial because of safety, data, or protocol concerns; it explains the reasons and what must change before testing can resume. For investors, it is like a stop-work order that can delay product development, raise costs, and increase risk by putting timelines and potential future revenue on hold until regulators are satisfied.

warrant liabilities financial

"due to a $108.1 million gain in 2024 from change in fair value of warrant liabilities"

Warrant liabilities are the financial obligations a company records when it grants warrants—special rights allowing someone to buy shares at a set price in the future. If the warrants are expected to be exercised, they are treated as a liability because the company might need to deliver shares or cash later. This matters to investors because it affects the company’s reported financial health and the potential dilution of existing shares.

stock-based compensation financial

"included a $2.6 million increase in stock-based compensation expense due to new awards granted"

Stock-based compensation is when a company pays employees, directors or consultants with shares or the right to buy shares instead of or in addition to cash. It matters to investors because issuing stock or options spreads ownership thinner (like cutting a pie into more slices), which can reduce each existing share’s claim on profits and can also change reported earnings; investors watch it to assess true cost of running the business and how management is incentivized.

loss contingency financial

"a $31.3 million securities litigation loss contingency and $4 million of other litigation contingencies"

A loss contingency is a potential future cost a company might have to pay because of events such as lawsuits, product claims, environmental cleanups or unresolved tax disputes. Investors care because these risks can reduce future cash, profits and company value; when a loss is likely and can be reasonably estimated, companies must set aside money or disclose it, much like spotting a dark cloud that might turn into a storm and planning accordingly.

AI-generated analysis. Not financial advice.

Working to advance TSC-related epilepsy program, with a focus on capital efficiency

AUSTIN, Texas, March 12, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (formerly Cassava Sciences, Inc.) (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company focused on developing novel medicines to modulate the filamin A protein for the treatment of central nervous system (CNS) disorders, such as Tuberous Sclerosis Complex (TSC)-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A, today reported financial results for the fourth quarter and year ended December 31, 2025, and provided a business update.

Net loss for 2025 was $91.0 million, or $1.88 per share, compared to a net loss of $24.3 million, or $0.53 per share (basic), in 2024. Net cash used in operations was $32.3 million in 2025, consistent with previous guidance.

The Company met cash guidance for year-end 2025, reporting $95.5 million, and estimates cash at June 30, 2026 in a range from $47 to $50 million. The Company estimates net cash use in operations for first half of 2026 in a range from $14 to $17 million, plus a payment of a $31.25 million estimated loss contingency related to the potential settlement of certain securities litigation recorded in 2025.

“At Filana Therapeutics, our name reflects our deep commitment to science and to patients affected by diseases tied to filamin A dysregulation, including TSC-related epilepsy. We are driven by the urgent need for new treatment options that can meaningfully improve patients’ lives,” said Rick Barry, President and Chief Executive Officer of Filana Therapeutics, Inc. “In partnership with our advisors, we are working diligently to address the FDA’s requests and look forward to sharing a progress update in the coming months.”

Corporate Updates:

• Name change to Filana Therapeutics, Inc.: Filana Therapeutics’ new name and brand reflect the Company’s strategic focus on developing novel medicines to modulate the filamin A protein for the treatment of CNS disorders, such as TSC-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A.
• TSC Program Update: The Company is actively addressing FDA’s request for information detailed in the Clinical Hold Letter received in December 2025, including the submission of additional pre-clinical data and protocol design modifications. The Company intends to submit a response to FDA as soon as practicable.
  
  

Financial Results for the Fourth Quarter and Full Year 2025:

• Cash and cash equivalents were $95.5 million, with no debt, as of December 31, 2025. This compares to cash and cash equivalents of $128.6 million at December 31, 2024. The Company estimates cash at June 30, 2026, in a range from $47 to $50 million.
• Total shares outstanding as of March 9, 2026, were 48.3 million.
• Net loss for the year ended December 31, 2025, was $91.0 million, or $1.88 per share. This compares to a net loss of $24.3 million, or $0.53 per share (basic) for the same period in 2024. Net loss increased primarily due to a $108.1 million gain in 2024 from change in fair value of warrant liabilities that was not repeated in 2025.
• Net cash used in operations was $32.3 million in 2025, consistent with previous guidance. The Company estimates net cash use in operations for first half of 2026 in a range from $14 to $17 million, plus a payment of $31.25 million estimated loss contingency related to the potential settlement of certain securities litigation recorded in 2025.
• Research and development (R&D) expenses for the year ended December 31, 2025, decreased to $26.6 million from $69.6 million in 2024, representing a 62% reduction. This decrease was due primarily to the phase out of the Alzheimer's disease (AD) development program beginning the fourth quarter 2024 and completed in second quarter 2025. The Company’s planned clinical program in TSC-related epilepsy is expected to cost significantly less than the discontinued AD program.
• General and administrative (G&A) expenses for the year ended December 31, 2025, decreased to $68.8 million from $71.8 million in 2024. The 4% decrease was due primarily to a $40.0 million SEC-related loss contingency recorded in 2024, which was partially offset by $9.9 million in insurance recoveries. This compared to a $31.3 million securities litigation loss contingency and $4 million of other litigation contingencies recorded in 2025, for which there were no insurance recoveries. The change also included a $2.6 million increase in stock-based compensation expense due to new awards granted in late 2024, as well as cost decreases as severance costs recorded in the prior year were not repeated in 2025. 
  
  

About TSC and TSC-related Epilepsy

TSC is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2 gene. This affects the mechanistic target of rapamycin (mTOR) pathway and can cause tumors to grow in multiple organs¹. Epilepsy is the most common health issue affecting the TSC community, with 80% to 90% of TSC patients experiencing seizures¹. TSC-related epilepsy affects approximately 45,000 people in the U.S.² Most patients start having seizures within their first year of life³. Even with multiple approved treatments, more than 60% of TSC patients remain refractory to antiepileptic therapy⁴.

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:

1. Crino P, Nathanson K, Petri Henske, E. The Tuberous Sclerosis Complex. N Engl J Med. (2006) 355 (13):1345-56. DOI: 10.1056/NEJMra055323
2. Zhang L, Huang T, Teaw S, Nguyen LH, Hsieh LS, Wong 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):eaay0289. DOI: 10.1126/scitranslmed.aay0289
3. https://www.tscalliance.org/understanding-tsc/what-is-tsc/
4. Chu-Shore, C. J., Major, P., Camposano, S., Muzykewicz, D., & Thiele, E. A. (2010). The natural history of epilepsy in tuberous sclerosis complex. Epilepsia, 51(7), 1236–1241. https://doi.org/10.1111/j.1528-1167.2009.02474.x
   
   

For More Information Contact:
Investors
Sandya von der Weid
svonderweid@lifesciadvisors.com

Company
Eric Schoen, Chief Financial Officer
(512) 501-2450
ESchoen@FilanaTx.com
IR@FilanaTx.com

Cautionary Note Regarding Forward-Looking Statements:

This news release contains forward-looking statements that may include but are not limited to statements regarding: our ability to successfully engage with, and satisfactorily respond to, requests for additional information from the U.S. Food and Drug Administration (FDA) concerning the full clinical hold on our investigational new drug application (IND) for simufilam in TSC-related epilepsy and the timing and outcomes of such interactions, the potential resolution of certain securities litigation and our loss contingency estimates and timing of payments related thereto, the timing and plans to conduct clinical studies with simufilam following approval of our IND, our plans to conduct additional preclinical studies of simufilam relating to seizures in TSC, the potential for simufilam as a treatment for TSC-related epilepsy and other potential indications, plans to present preclinical results in an upcoming scientific conference or publication, the timing of anticipated milestones, expected cash balances and cash use in future periods. These statements may be identified by words such as “anticipate”, “before”, “believe”, “could”, “expect”, “forecast”, “intend”, “may”, ”pending”, “plan”, “possible”, “potential”, “prepares for”, “will”, and other words and terms of similar meaning.

Such statements are based on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to our ability to provide FDA with additional information, including additional pre-clinical data, and modifying the proposed clinical trial protocol design, to satisfy completion of FDA’s review and release of full clinical hold, the ability to advance preclinical studies related to TSC-related epilepsy, and other potential indications, the ability to successfully carry out the Company’s obligations under the Yale License Agreement, the ability to initiate an initial proof-of-concept study of simufilam in TSC-related epilepsy, and other risks inherent in drug discovery and development or specific to Filana Therapeutics, Inc., as described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the period ended September 30, 2025, and subsequent reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov.

All of our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates is approved or available for sale anywhere in the world.

Our clinical results from earlier-stage clinical trials or preclinical studies may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.

We are in the business of new drug discovery and development. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q in their entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery and development, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested.

– Financial Tables Follow –

FILANA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
		Three months ended December 31,								Year Ended December 31,
		2025				2024				2025				2024
Operating expenses
Research and development		$	3,853			$	20,530			$	26,590			$	69,637
General and administrative			9,699				8,957				68,800				71,809
Total operating expenses			13,552				29,487				95,390				141,446
Operating loss			(13,552	)			(29,487	)			(95,390	)			(141,446	)
Interest income			974				1,800				4,620				8,510
Other income (loss), net			39				90				(203	)			411
Gain from change in fair value of warrant liabilities			—				—				—				108,183
Net loss		$	(12,539	)		$	(27,597	)		$	(90,973	)		$	(24,342	)
Net loss per share, basic		$	(0.26	)		$	(0.57	)		$	(1.88	)		$	(0.53	)
Net loss per share, diluted			(0.26	)			(0.57	)			(1.88	)			(1.46	)
Weighted-average shares used in computing net loss per share, basic			48,308				48,099				48,297				46,329
Weighted-average shares used in computing net loss per share, diluted			48,308				48,099				48,297				46,604
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
										Year Ended December 31,
										2025				2024
Assets
Current assets
Cash and cash equivalents										$	95,502			$	128,574
Prepaid expenses and other current assets											2,207				7,958
Total current assets											97,709				136,532
Property and equipment, net											20,646				21,001
Total assets										$	118,355			$	157,533
Liabilities and stockholders' equity
Current liabilities
Accounts payable and other accrued expenses										$	41,647			$	7,654
Accrued development expense											364				2,440
Accrued compensation and benefits											1,625				1,357
Other accrued liabilities											198				299
Total current liabilities											43,834				11,750
Other non- current liabilities											118				79
Total liabilities											43,952				11,829
Stockholders' equity
Common Stock and additional paid-in-capital											570,487				550,815
Accumulated deficit											(496,084	)			(405,111	)
Total stockholders' equity											74,403				145,704
Total liabilities and stockholders' equity										$	118,355			$	157,533

FAQ

What was Filana Therapeutics' (FLNA) net loss for 2025 and how does it compare to 2024?

Filana reported a $91.0 million net loss in 2025, a significant increase versus 2024. According to the company, net loss was $91.0 million ($1.88 per share) in 2025 compared with $24.3 million ($0.53 per share) in 2024, driven partly by nonrecurring 2024 gains.

How much cash did FLNA have at year-end 2025 and what is the June 30, 2026 cash estimate?

Filana held $95.5 million in cash at December 31, 2025 and estimates lower cash by mid-2026. According to the company, estimated cash at June 30, 2026 ranges from $47 million to $50 million, reflecting planned operating use and contingencies.

Why did Filana's R&D expenses decline sharply in 2025 (FLNA)?

R&D fell to $26.6 million in 2025, down 62% year-over-year. According to the company, the decline resulted primarily from phasing out the Alzheimer's program between Q4 2024 and Q2 2025, reducing development costs significantly.

What is the $31.25 million payment referenced by Filana (FLNA)?

The $31.25 million is an estimated loss contingency payment related to securities litigation. According to the company, this potential settlement was recorded in 2025 and is expected to be paid in the first half of 2026 in addition to operating cash use.

What is the status of Filana's TSC-related epilepsy program and FDA interactions (FLNA)?

Filana is actively responding to an FDA clinical hold and preparing additional data and protocol changes. According to the company, it is submitting preclinical data and protocol modifications and intends to file a response to the FDA as soon as practicable.