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Filana Therapeutics, Inc.NasdaqCM:FLNA Stock Report

Market Cap US$61.8m
Share Price
US$1.20
US$8
85.0% undervalued intrinsic discount
1Y-35.5%
7D-13.0%
Portfolio Value
View

Filana Therapeutics, Inc.

NasdaqCM:FLNA Stock Report

Market Cap: US$61.8m

Filana Therapeutics (FLNA) Stock Overview

A clinical stage biotechnology company, develops drugs for neurodegenerative diseases. More details

FLNA fundamental analysis
Snowflake Score
Valuation2/6
Future Growth0/6
Past Performance0/6
Financial Health6/6
Dividends0/6

FLNA Community Fair Values

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Filana Therapeutics, Inc. Competitors

Price History & Performance

Summary of share price highs, lows and changes for Filana Therapeutics
Historical stock prices
Current Share PriceUS$1.20
52 Week HighUS$4.98
52 Week LowUS$1.20
Beta-0.76
1 Month Change-26.83%
3 Month Change-44.19%
1 Year Change-35.48%
3 Year Change-95.25%
5 Year Change-97.43%
Change since IPO-99.22%

Recent News & Updates

Recent updates

Seeking Alpha Mar 04

Cassava: Low-Cost Pivot Into TSC Epilepsy Is Unlikely To Create Long-Term Value

Summary Cassava Sciences' pivot to TSC via a Yale license deal for simufilam addresses both new indications and reputation issues but faces significant clinical and market challenges. Preclinical studies show simufilam's potential in treating TSC-related seizures, but translating these results to human efficacy remains uncertain. Cassava's strong liquidity with $128.6 million in cash supports early-stage development, yet long-term funding needs may lead to shareholder dilution. Despite strategic moves, Cassava remains a "sell" due to high risks, competition, and the need for significant clinical validation. Read the full article on Seeking Alpha
Seeking Alpha Nov 07

Cassava Q3 Earnings Review: It Feels Like The End May Be Nigh

Summary Cassava Sciences' stock has declined significantly since its peak, with ongoing skepticism about the efficacy of its Alzheimer's drug, simufilam. Phase 3 trial results for simufilam are anticipated by year-end, which could either validate or disprove its effectiveness. Cassava has faced legal and scientific scrutiny, with key figures resigning and the company settling a $40m SEC penalty. The new CEO remains cautiously optimistic but acknowledges the potential for ambiguous results and the need for further FDA consultations. Read the full article on Seeking Alpha
Seeking Alpha Jul 24

Cassava Sciences: Turning The Corner Into A Brick Wall

Summary Cassava Sciences' mechanism of action for simufilam has not been independently verified. Simufilam only slows down the progression of solidly mild Alzheimer's disease for one year; it does not stablize mild Alzheimer's disease for two years as the company claims. The FDA is unlikely to approve another drug with limited short-term effectiveness, especially one which while safe is surrounded by so much controversy. Read the full article on Seeking Alpha
Analysis Article Oct 17

Cassava Sciences (NASDAQ:SAVA) Is In A Good Position To Deliver On Growth Plans

Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
Analysis Article Jul 04

We're Hopeful That Cassava Sciences (NASDAQ:SAVA) Will Use Its Cash Wisely

We can readily understand why investors are attracted to unprofitable companies. For example, although Amazon.com made...
Analysis Article Mar 05

We're Not Very Worried About Cassava Sciences' (NASDAQ:SAVA) Cash Burn Rate

Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
Analysis Article Nov 19

Cassava Sciences (NASDAQ:SAVA) Is In A Good Position To Deliver On Growth Plans

Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
Seeking Alpha Oct 13

Cassava Sciences begins extension study of Alzheimer's drug simufilam

Cassava Sciences (NASDAQ:SAVA) has begun an open-label extension study of its Alzheimer's disease candidate simufilam that will last a year. The trial is expected to enroll ~1.6K participants. Enrollment is set to begin in November. The study is for participants that have completed one of the company's two phase 3 trials. They will be given 100 mg simufilam twice daily. Seeking Alpha contributor Biotech Beast views Cassava Sciences (SAVA) as a strong sell as there is still a great deal of uncertainty hanging over the stock.
Seeking Alpha Sep 29

Cassava Sciences Stock: Huge Returns Or Catastrophic Losses

Summary This is a highly speculative bet. There has been a constant litany of accusations of wrongdoing on the science. There have been several recent positive developments. The data readouts will be massive catalysts. This is such a binary investment you will either do very well, or be left holding the bag. It has been quite some time since we checked on the very volatile and controversial Cassava Sciences (SAVA). At last check, we felt this was going to remain one of the most controversial and volatile stocks as we had into 2022. We are ultimately bullish on the science, but the stock action has been akin to gambling. The stock got pushed down hard this year as a number of questions regarding the research and business practices were raised. The thing is that this stock can make you some really fast gains on both the long and short side of the trade. However, we see the potential for multiple orders of gains should the science hold up here. In other words, it makes a great swing trading stock, but for the medium/long term, you are essentially buying a possible play that could see 5-10X gains, or be worthless, all depending on the science and how it plays out. The science called into question The science has been getting called into question for over a year. That has impacted the crazy volatility even further, and is why it is one of those stocks that lead many to consider Wall Street a casino. The ultimate question is can their drug, simufilam, designed to treat Alzheimer's disease work? We are hoping for humanity's sake that one of the companies working on this type of treatment finds success. Alzheimer's is a horrible affliction and has impacted many of our lives in some capacity or another. So there is a lot of hope with these research candidates under study, such as simufilam, for those suffering from Alzheimer's as well as their loved ones. There just are not effective treatments on the market. That said, the initial data readouts have been positive, but have been met with extreme criticism. You may recall that the interim analysis demonstrated a 1.6 point improvement in the ADAS-Cog11 system in Alzheimer's patient's cognition level rating. So what? Well as it turns out, that is a 10% average improvement. The readout also showed that there was a near 30% improvement in behaviors such as agitation and fear. Those were good results. The constant mantra has been that the company has falsified and manipulated data to make the drug look better. This has cast a cloud on the company and shares have suffered for months. But things are looking up. Some positive developments There has been some insider buying as well. A director, Richard Barry, bought 36.16K shares of common stock at $23.79 on Aug. 23 for $860K. This was an increase in the position of nearly 20% and Barry now has ownership of 186,159 shares. The stock has almost doubled since then. Volumes are up the last month, but the most beneficial news was the recent clearing by one medical journal of the company doing anything wrong in terms of data manipulation. The company has been accused of research misconduct by several entities. There continue to be bears putting their faith in accusations of some possible misdealings related to data collection and reporting. Last year we saw scientific victory, in The Journal of Neuroscience. In that review by the Journal of Neuroscience, an investigation and critical review showed no evidence of data manipulation in one of the technical papers that was an early key to effectiveness of simufilam. Back in 2012 when the drug was first being looked at for possible effectiveness, the accusations from the group claimed the data was manipulated and false. The company responded saying these allegations were false. Essentially they claimed the western blots, which measure proteins and changes, were falsified. Recently the Neuroscience journal reviewed data, and there is once again "no evidence to support claims of data manipulation in a 2005 paper" authored by the company and its scientific collaborators. This summer a scientist called into question foundational research on amyloid plaque theory, as basis for simufilam's target work. Then just a few weeks ago, the journal had cleared the company of scientific misconduct. Then, with little coverage surprisingly, the SEC which was investigating the company also concluded that they recommend closing their investigation. This work was covered in great detail by fellow contributor Jacob Braun. With the huge short interest in the stock, trading has been wild and the stock has rallied. Needless to say, it has been a journey. But the company is not out of the woods entirely. Cassava is still awaiting the results of an investigation from The City University of New York on one of its own researchers who published positive results on simufilam that has come under some of the same data related scrutiny. There is also controversy after the company was accused of being investigated by the Justice Department, something the company denied vehemently. Looking ahead As we look ahead, the company has enough cash to fund operations for at least two more years. It has nearly $200 million in cash and absolutely no debt. The company spends anywhere from $15-$25 million a quarter (more when trials underway, and being set up), so that is at least two years of funding. We believe that with pending data readouts, the investment thesis will have played out by then, as the drug will likely be considered successful or a failure. It may even be approved.
Seeking Alpha Sep 21

Cassava Sciences: Trying To Manage Expectations

Summary The second group of patients on simufilam on average experienced a .2 point decline in ADAS-Cog scores after one year. These results are similar to acetylcholinesterase inhibitors for mild Alzheimer's disease. Critics claim that some individuals in the first group who experienced a mean improvement of 3.2 did not have Alzheimer's, whereas supporters claim this is true for the second group. Accurate MMSE numbers for both groups would add more clarity to the situation. The apparent mechanisms of action for simufilam suggest that further decline from baseline is likely. An explanation is needed as to why the first group of fifty trial participants on Cassava Sciences' (SAVA) simufilam experienced a 3.2 improvement in ADAS-Cog scores while the second group experienced a .2 point decline. Critics have asserted that at least some of those in the first group did not have Alzheimer's disease. Cassava Sciences advocates apparently taking their cue from the company now have tried to flip the script by arguing that some in the second group did not have Alzheimer's disease but instead had some other form of dementia or mixed dementia, such as Alzheimer's disease and vascular dementia. That is why they did not perform as well. It is impossible to resolve this controversy with the data at hand, but there are clues to a possible answer. According to Cassava Sciences, the first group had a mean ADAS-cog score of 15.5 and a mean MMSE score of 22.1, but a mean ADAS-cog score of 15.5 corresponds to a mean MMSE score of 25.5 (table one). An MMSE score of between 21 and 24 is usually indicative of mild Alzheimer's disease. Some of those with higher MMSE scores in the first group may have been allowed into the trial based on being amyloid positive. But being amyloid positive is not the same thing as having Alzheimer's disease. Individuals with strong antioxidant levels in their brain can have significant amounts of amyloid and not have Alzheimer's disease (study). It is likely, then, that some people in the first group had mild cognitive impairment, very early Alzheimer's disease, or were cognitively normal. The results from the second group of 50 patients are even more difficult to interpret because there is no public record of their baseline scores and characteristics: MMSE scores, ADAS-cog scores, age, gender, ethnicity, APOE4 status, etc. Nothing. The contention made by some of the company's backers is that some individuals in this group did not go under intensive testing to determine if they had Alzheimer's disease. If that is the case, then some participants were admitted into the trial based solely on their MMSE scores. Just like amyloid, MMSE scores alone cannot be used to provide a definitive diagnosis of Alzheimer's disease. So it is possible that a few of these individuals had either some other form of dementia or mixed dementia. But even if this is the case, treatments that lessen oxidative stress in Alzheimer's disease are likely to have at least some benefits in terms of cognition for those with other forms of dementia (possibility). Knowing the actual MMSE scores of the trial participants in both groups would not completely resolve this debate, but it would go a long way in that direction. If there is a significant gap in terms of baseline MMSE scores between the two groups, this would strongly indicate (but not prove) that more people in the second group had mild Alzheimer's disease than in the first group. If the .2 point decline is reflective of the effects of simufilam for mild Alzheimer's disease, this would put it right in line with acetylcholinesterase inhibitors for mild Alzheimer's disease (chart). And this may be no accident. Acetylcholinesterase inhibitors such as Aricept inhibit oxidative stress as sigma-1 agonists and are peroxynitrite decomposition catalysts (a nitro-oxidant that probably plays a key role in Alzheimer's disease). Simufilam potentially at least can do the same (previous article). About 20 percent of the population does not have a functioning sigma-1 receptor, so they do not benefit from this form of treatment. Sigma-1 receptor activity declines with the progression of Alzheimer's disease, so this type of treatment does not work nearly as well for moderate Alzheimer's disease as it does for mild Alzheimer's disease. This may explain why some participants responded better to simufilam than others. Not only the results but probably the mechanism of action of simufilam is in need of adjustment. Cassava Sciences has always presented itself outside the realm of various other anti-amyloid treatments, but it too is an amyloid-centric approach. The company's stated mechanism of action is that by restoring filamin A to its normal configuration, it reduces amyloid toxicity by "disabling its signalling" via nicotinic acetylcholine and toll-like receptors (publication). Yet, in trials where nearly all amyloid was removed, Alzheimer's disease continues to progress. It does not take a very small amount of amyloid to contribute to Alzheimer's disease, it requires a lot (such as the case with APOE4 carriers). In non-APOE4 carriers who have less amyloid, anti-amyloid drugs don't work at all (latest example from Eli Lilly). It is possible that simufilam produces beneficial results even in the absence of amyloid. For instance, simufilam may be a zinc and copper chelator, which may be of some significance in that zinc and copper contribute to the misfolding of proteins as well as to their toxicity. If this is the case, then it is the presence of copper and zinc and not any particular misfolded protein that can at least early on contribute to the progression of Alzheimer's disease. Eventually, though, copper and zinc are entombed in amyloid plaques, so their role in Alzheimer's disease declines. It is possible, though, that a small part of simufilam's early benefit is as a copper and zinc chelator. The role of misfolded proteins by themselves in Alzheimer's disease is somewhat uncertain. Misfolded amyloid by itself probably does no damage to the brain. Misfolded tau proteins can inhibit neurotransmissions. It is unclear at this point if misfolded filamin A proteins do any damage to the brain or not.
Seeking Alpha Sep 09

Cassava Sciences reaches over five-month high on rising volumes

After a sharp selloff early this year, clinical-stage biotech Cassava Sciences (NASDAQ:SAVA) appears to be turning the tide, with its shares rising for the fourth straight session Friday on above-average volume to reach the highest level since April. Nearly 2.9M SAVA shares have changed hands so far, compared to the 65-day average of ~2.4M. The upsurge comes as SAVA, a developer of an Alzheimer’s therapy, is set to participate in an investor conference organized by H.C. Wainwright next week. SAVA stock crashed in late July after Reuters reported that the U.S. Justice Department had initiated a criminal probe over its experimental Alzheimer’s therapy, a claim company denied. Despite a ~31% selloff in 2022, SAVA shares have recovered since then, adding ~78% to strongly outperform the ~5% gain of the SPDR S&P Biotech ETF (XBI). The rally coincided with two recent insider purchases, including those from Directors Sanford Robertson and Barry Richard. Robertson, the principal of technology buyout fund Francisco Partners, bought 100K SAVA shares in August for over $2M to raise his stake by ~11%.
Seeking Alpha Sep 03

Cassava Sciences Looks As Good Of A Purchase As Ever

Summary Multiple insiders have purchased shares on the open market in the last month. The company has now released positive 100 patient 12-month data. Another journal cleared the company of any wrongdoing. The SEC has officially ended any inquiries into the company. Introduction I give a strong buy rating to Cassava Sciences (SAVA). Throughout the drops, I have continued to add shares and DCA. In the past, I called Cassava Sciences the best risk to reward in the stock market, and when the price becomes even more attractive over noise, it makes it an even better risk to reward. Big pharma spent billions of dollars searching for drugs to help patients with Alzheimer's Disease ((AD)). Yet, a small former pain company out of Austin, Texas – a place not known as a biotech mecca – has released data that blows everybody else's products out of the water. Unlike its competitors' expensive, impractical IV solutions full of safety issues, Cassava Sciences' solution is a small pill without known safety concerns. From the graveyard of AD therapy has come life called Simufilam. Because of this unlikeliness, the company has been shorted down to pennies of its all-time highs achieved last summer. While shorting a highly hyped stock is usually a brilliant bet, based on looking at all claims for and against the company, I believe that Cassava Sciences has seemingly done the impossible. You can read my bullish public coverage going back well over a year on Seeking Alpha and my reasons for my strengthening belief below. Four Bullish Events Since We Last Spoke As stated by Peter Lynch, "Insiders might sell their shares for any number of reasons, but they buy them for only one: they think the price will rise." And buy the Cassava Sciences insiders have done. Since the last quarterly report, four insiders have purchased over $3 million in shares on the open market, including longtime Salesforce (CRM) board member and supporter of Neuroscience Sanford Robertson, increasing his share position by ~10% to push him past 1 million shares. In addition to the above buying, no insider has sold shares for years. Insiders have privileged information, and their moves speak volumes. These insiders are yelling very loudly as they try to get their hands on as many shares as possible. The last insider buy on the open market was September 24th, 2020, shortly before the stock rose in the summer of 2021 to over $100 and became the top performing stock of the year. Even more importantly, this was three months before the company announced its groundbreaking six-month OLE results. The company insiders likely had a closed buying period shortly after that purchase and at least through the data announcements of 2021. September 2020 was most likely the last time insiders had the chance to buy on the open market, considering we have not seen any buys between these two open market buys. One thing that undoubtedly strengthened the insiders' belief was when on August 3rd the company announced 12-month data for 100 patients from its phase 3 trials. While the second 50 cohort was admittedly not as good as the first 50, the second 50 was still very good. Highlights from the data are that 63% of patients improved cognition, a remarkable achievement considering that AD is a disease of continual decline. Additionally, another 21% of patients slowed less than five cognitive points, meaning that the drug was able to slow down the effects of AD. Overall, 84% of patients saw a positive impact from the drug. If the company is able to achieve a result anywhere close to this while the drug's safety profile remains impeccable, then I would be shocked if they were unable to secure approval. The 100 patient data further de-risks the stock by decreasing the chances of a phase 3 failure. In the middle of the frenzy of insider buyers, a surprise occurred when yet another scientific journal found no data manipulation in Cassava Science's scientific publications on Simufilam. The Journal of Prevention of Alzheimer's Disease ((JPAD)) is a positive step in the right direction while we wait for critical regulatory clearance from the City University of New York ((CUNY)). Many retail investors question the importance of CUNY, but that is because its importance is not for retail investors. Instead, its importance is for institutional investors. I speculate that this is the hold-up for many institutions purchasing the stock, resulting in very low institutional ownership. Institutions have to answer to their clients, and no matter how good the data for Cassava Sciences look, if an institution invested before a CUNY clearance and CUNY ruled against Cassava Sciences, then the institution would have some severe repercussions to face. While we are still waiting on CUNY, we have positive news that the SEC has concluded all its inquiries into the company. From SEC investigation expert John P Gavin from Disclosure Insight's work, we can tell that the SEC performed an extensive inquiry into Cassava Sciences, totaling 48 boxes of documents that did not end in any formal investigation. CEO Remi Barbier said the company gave "nearly 100,000 pages of documents to an alphabet soup of outside investigative agencies … [they have] yielded an important finding to date: there is no evidence of research misconduct." Commercially bought paper comes in 5000 pages for a box, but loose leaf paper fits much looser in a box. From my research, only about 2500 pieces of loose leaf paper can fit in a box, so the number of documents from this quote aligns with the 48-box comment from the SEC. Regardless of the amount, it is in the rearview mirror for the company. Events on the Horizon Before the end of the year, Cassava Sciences should release 12-month data for 200 patients from its OLE trial, which will further boost the odds of success in phase three trials if the data continues to be positive. Additionally, the company will release 12-month biomarker data for 25 patients, which will provide another validation for Cassava Sciences' data results. Something to remember is that Aduhelm from Biogen (BIIB) was approved based on biomarker data, not cognitive data. Looking ahead, mid-2023 should yield the results of the company's cognition maintenance study showing data from patients on the drug for 18 months and having the first placebo-controlled data. Finally, the company will have completed phase three trials in early to mid-2024, whose results will determine whether or not Simufilam gets approved. The coming two years will be exhilarating for Cassava Sciences' investors. Financials
Seeking Alpha Aug 26

Cassava Sciences stock jumps 10% after director buys $860K shares

In a regulatory filing, Cassava Sciences (NASDAQ:SAVA) disclosed that its director Richard Barry bought 36.16K shares of common stock at $23.79 on Aug.23 for a total outlay of $860K. The move leaves Richard Barry with ownership of 186,159 shares. A quick look at the company's ownership structure: Shares of Cassava Sciences are up 10.37% afterhours at $30.11.

Shareholder Returns

FLNAUS PharmaceuticalsUS Market
7D-13.0%-1.0%1.5%
1Y-35.5%36.0%25.5%

Return vs Industry: FLNA underperformed the US Pharmaceuticals industry which returned 30.4% over the past year.

Return vs Market: FLNA underperformed the US Market which returned 26.2% over the past year.

Price Volatility

Is FLNA's price volatile compared to industry and market?
FLNA volatility
FLNA Average Weekly Movement10.2%
Pharmaceuticals Industry Average Movement9.9%
Market Average Movement7.2%
10% most volatile stocks in US Market16.0%
10% least volatile stocks in US Market3.2%

Stable Share Price: FLNA has not had significant price volatility in the past 3 months compared to the US market.

Volatility Over Time: FLNA's weekly volatility (10%) has been stable over the past year.

About the Company

FoundedEmployeesCEOWebsite
199819Rick Barrywww.filanatx.com

Filana Therapeutics, Inc., a clinical stage biotechnology company, develops drugs for neurodegenerative diseases. Its lead therapeutic product candidate is simufilam, a small molecule drug, which is in Phase 3 clinical trial to treat Alzheimer’s disease; and investigational diagnostic product candidate is SavaDx, an early-stage program focused on detecting the presence of Alzheimer’s disease from a small sample of blood. The company was formerly known as Cassava Sciences, Inc. and changed its name to Filana Therapeutics, Inc. in March 2026.

Filana Therapeutics, Inc. Fundamentals Summary

How do Filana Therapeutics's earnings and revenue compare to its market cap?
FLNA fundamental statistics
Market capUS$61.83m
Earnings (TTM)-US$77.90m
Revenue (TTM)n/a
0.0x
P/S Ratio
-0.7x
P/E Ratio

Earnings & Revenue

Key profitability statistics from the latest earnings report (TTM)
FLNA income statement (TTM)
RevenueUS$0
Cost of RevenueUS$26.59m
Gross Profit-US$26.59m
Other ExpensesUS$51.31m
Earnings-US$77.90m

Last Reported Earnings

Mar 31, 2026

Next Earnings Date

n/a

Earnings per share (EPS)-1.61
Gross Margin0.00%
Net Profit Margin0.00%
Debt/Equity Ratio0%

How did FLNA perform over the long term?

See historical performance and comparison

Company Analysis and Financial Data Status

DataLast Updated (UTC time)
Company Analysis2026/05/12 14:46
End of Day Share Price 2026/05/12 00:00
Earnings2026/03/31
Annual Earnings2025/12/31

Data Sources

The data used in our company analysis is from S&P Global Market Intelligence LLC. The following data is used in our analysis model to generate this report. Data is normalised which can introduce a delay from the source being available.

PackageDataTimeframeExample US Source *
Company Financials10 years
  • Income statement
  • Cash flow statement
  • Balance sheet
Analyst Consensus Estimates+3 years
  • Forecast financials
  • Analyst price targets
Market Prices30 years
  • Stock prices
  • Dividends, Splits and Actions
Ownership10 years
  • Top shareholders
  • Insider trading
Management10 years
  • Leadership team
  • Board of directors
Key Developments10 years
  • Company announcements

* Example for US securities, for non-US equivalent regulatory forms and sources are used.

Unless specified all financial data is based on a yearly period but updated quarterly. This is known as Trailing Twelve Month (TTM) or Last Twelve Month (LTM) Data. Learn more.

Analysis Model and Snowflake

Details of the analysis model used to generate this report is available on our Github page, we also have guides on how to use our reports and tutorials on Youtube.

Learn about the world class team who designed and built the Simply Wall St analysis model.

Industry and Sector Metrics

Our industry and section metrics are calculated every 6 hours by Simply Wall St, details of our process are available on Github.

Analyst Sources

Filana Therapeutics, Inc. is covered by 4 analysts. 1 of those analysts submitted the estimates of revenue or earnings used as inputs to our report. Analysts submissions are updated throughout the day.

AnalystInstitution
Gregory FraserBofA Global Research
Mayank MamtaniB. Riley Securities, Inc.
Elemer PirosLucid Capital Markets