Overview
- TickerFLNA on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersAustin, Texas1
- Incorporated inDE2
- Business address6801 N Capital Of Texas Highway, Building 1; Suite 300, Austin, Tx 787312
- Filer categoryNon-accelerated filer, Smaller reporting company2
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Filana Therapeutics, Inc. (formerly Cassava Sciences, Inc.) is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to develop transformative medicines to improve the lives of patients with central nervous system (CNS) disorders, such as Tuberous Sclerosis Complex (TSC)-related epilepsy and other diseases associated with dysregulation or overexpression of filamin A. Our science is based on modulating the activity of a critical protein in the brain for patients with certain CNS disorders, such as TSC. Our lead therapeutic drug candidate, simufilam, was under clinical evaluation for the proposed treatment of Alzheimer’s disease in two Phase 3 clinical studies through 2024, when all ongoing clinical trials for simufilam in Alzheimer’s disease were discontinued. The phase out of the Company’s Alzheimer's disease development program was completed in the second quarter…4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Financial statements
Every line of the income statement as filed: the last 3 fiscal years, latest first.9
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Research and development | $26.6M | $69.6M | $89.4M |
| General and administrative | $68.8M | $71.8M | $16.5M |
| Total operating expenses | $95.4M | $141.4M | $106.0M |
| Operating loss | -$95.4M | -$141.4M | -$106.0M |
| Interest income | $4.6M | $8.5M | $7.8M |
| Other income (loss), net | -$203.0K | $411.0K | $907.0K |
| Gain from change in fair value of warrant liabilities | $0 | $108.2M | $0 |
| Shares used in computing net loss per share, basic (in shares) | 48.3M shares | 46.3M shares | 41.9M shares |
| Net loss per share, basic (in dollars per share) | -$1.88 | -$0.53 | -$2.32 |
| Net loss | -$91.0M | -$24.3M | -$97.2M |
| Adjustment for change in fair value of warrant liabilities | $0 | -$43.8M | $0 |
| Adjusted numerator, diluted | -$91.0M | -$68.1M | -$97.2M |
| Shares used in computing net loss per share, diluted (in shares) | 48.3M shares | 46.6M shares | 41.9M shares |
| Net loss per share, diluted (in dollars per share) | -$1.88 | -$1.46 | -$2.32 |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.9
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 | 2022-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $95.5M | $128.6M | ||
| Prepaid expenses and other current assets | $2.2M | $8.0M | ||
| Total current assets | $97.7M | $136.5M | ||
| Property and equipment, net | $20.6M | $21.0M | ||
| Total assets | $118.4M | $157.5M | ||
| Accounts payable and other accrued expenses | $41.6M | $7.7M | ||
| Accrued development expense | $364.0K | $2.4M | ||
| Accrued compensation and benefits | $1.6M | $1.4M | ||
| Other current liabilities | $198.0K | $299.0K | ||
| Total current liabilities | $43.8M | $11.8M | ||
| Other non-current liabilities | $118.0K | $79.0K | ||
| Total liabilities | $44.0M | $11.8M | ||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized, none issued and outstanding | $0 | $0 | ||
| Common stock, $0.001 par value; 120,000,000 shares authorized; 48,307,896 and 48,203,179 shares issued and outstanding at December 31, 2025 and 2024, respectively | $48.0K | $48.0K | ||
| Additional paid-in capital | $570.4M | $550.8M | ||
| Accumulated deficit | -$496.1M | -$405.1M | ||
| Total stockholders' equity | $74.4M | $145.7M | $137.5M | $227.5M |
| Total liabilities and stockholders' equity | $118.4M | $157.5M | ||
| Preferred stock, par value (in dollars per share) | $0.00 | $0.00 | ||
| Preferred stock, shares authorized (in shares) | 10.0M shares | 10.0M shares | ||
| Preferred stock, shares issued (in shares) | 0 shares | 0 shares | ||
| Preferred stock, shares outstanding (in shares) | 0 shares | 0 shares | ||
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | ||
| Common stock, shares authorized (in shares) | 120.0M shares | 120.0M shares | ||
| Common stock, shares issued (in shares) | 48.3M shares | 48.2M shares | ||
| Common stock, shares outstanding (in shares) | 48.3M shares | 48.2M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 | 2022-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $95.5M | $128.6M | ||
| Prepaid expenses and other current assets | $2.2M | $8.0M | ||
| Total current assets | $97.7M | $136.5M | ||
| Property and equipment, net | $20.6M | $21.0M | ||
| Total assets | $118.4M | $157.5M | ||
| Accounts payable and other accrued expenses | $41.6M | $7.7M | ||
| Accrued development expense | $364.0K | $2.4M | ||
| Accrued compensation and benefits | $1.6M | $1.4M | ||
| Other current liabilities | $198.0K | $299.0K | ||
| Total current liabilities | $43.8M | $11.8M | ||
| Other non-current liabilities | $118.0K | $79.0K | ||
| Total liabilities | $44.0M | $11.8M | ||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized, none issued and outstanding | $0 | $0 | ||
| Common stock, $0.001 par value; 120,000,000 shares authorized; 48,307,896 and 48,203,179 shares issued and outstanding at December 31, 2025 and 2024, respectively | $48.0K | $48.0K | ||
| Additional paid-in capital | $570.4M | $550.8M | ||
| Accumulated deficit | -$496.1M | -$405.1M | ||
| Total stockholders' equity | $74.4M | $145.7M | $137.5M | $227.5M |
| Total liabilities and stockholders' equity | $118.4M | $157.5M | ||
| Preferred stock, par value (in dollars per share) | $0.00 | $0.00 | ||
| Preferred stock, shares authorized (in shares) | 10.0M shares | 10.0M shares | ||
| Preferred stock, shares issued (in shares) | 0 shares | 0 shares | ||
| Preferred stock, shares outstanding (in shares) | 0 shares | 0 shares | ||
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | ||
| Common stock, shares authorized (in shares) | 120.0M shares | 120.0M shares | ||
| Common stock, shares issued (in shares) | 48.3M shares | 48.2M shares | ||
| Common stock, shares outstanding (in shares) | 48.3M shares | 48.2M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 3 fiscal years, latest first.9
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Net loss | -$91.0M | -$24.3M | -$97.2M |
| Stock-based compensation | $19.6M | $16.3M | $4.6M |
| Gain from change in fair value of warrant liabilities | $0 | -$108.2M | $0 |
| Depreciation | $903.0K | $952.0K | $1.1M |
| Amortization of intangible assets | $33.0K | $180.0K | $446.0K |
| Prepaid expenses and other current assets | $6.1M | $539.0K | $1.7M |
| Operating lease right-of-use assets and liabilities | $0 | $0 | -$17.0K |
| Accounts payable and other accrued expenses | $34.0M | -$2.9M | $6.9M |
| Accrued development expense | -$2.1M | -$597.0K | $757.0K |
| Accrued compensation and benefits | $268.0K | $1.2M | $30.0K |
| Other liabilities | -$62.0K | -$7.0K | -$304.0K |
| Net cash used in operating activities | -$32.3M | -$116.9M | -$82.0M |
| Purchases of property and equipment | -$581.0K | -$103.0K | -$414.0K |
| Net cash used in investing activities | -$581.0K | -$103.0K | -$414.0K |
| Proceeds from issuance of common stock upon exercise of stock options | $90.0K | $918.0K | $2.6M |
| Proceeds from exercise of common stock warrants, net of exercise costs | $0 | $123.6M | $0 |
| Net cash (used in) / provided by financing activities | -$239.0K | $124.5M | $2.6M |
| Net increase (decrease) in cash and cash equivalents | -$33.1M | $7.4M | -$79.9M |
| Issuance of warrants resulting in recognition of warrant liabilities | $0 | $113.4M | $0 |
| Derecognition of warrant liabilities upon exercise of warrants | $0 | -$5.2M | $0 |
No quarter-by-quarter statement was filed.
Corporate structure
FILANA THERAPEUTICS, INC. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of FILANA THERAPEUTICS, INC.
- VANGUARD GROUP INC Filed SCHEDULE 13G/A on FILANA THERAPEUTICS, INC., latest Jul 29, 2025 (4 filings since Feb 9, 2022)
- BlackRock Filed SCHEDULE 13G/A on FILANA THERAPEUTICS, INC., latest Jul 16, 2025 (4 filings since Feb 3, 2022)
- Matthew Nachtrab Filed SCHEDULE 13G/A on FILANA THERAPEUTICS, INC., latest Nov 26, 2024 (2 filings since Aug 21, 2024)
- Remi Barbier Filed SC 13G/A on FILANA THERAPEUTICS, INC., latest Nov 4, 2024 (3 filings since Feb 3, 2022)
- FILANA THERAPEUTICS, INC. Austin, Texas
- Austin Innovation Park, LLC Subsidiary · Texas, United States
Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What FILANA THERAPEUTICS, INC. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $24.8M9 Dec 31, 2025 | $24.2M9 Dec 31, 2024 | +2.3% |
| Accumulated depreciation | $4.1M9 Dec 31, 2025 | $3.2M9 Dec 31, 2024 | +27.9% |
| Property and equipment, net | $20.6M9 Dec 31, 2025 | $21.0M9 Dec 31, 2024 | −1.7% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $95.5M9 Dec 31, 2025 | $128.6M9 Dec 31, 2024 | −25.7% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Intangible assets, net (excluding goodwill) | $37.0K8 Dec 31, 2024 | $176.0K8 Dec 31, 2023 | −79.0% |
| Finite-lived intangibles, gross | $1.6M9 Dec 31, 2025 | $1.4M9 Dec 31, 2024 | +13.7% |
| Accumulated amortization | $1.4M9 Dec 31, 2025 | $1.4M9 Dec 31, 2024 | +2.5% |
| Finite-lived intangibles, net | $193.0K9 Dec 31, 2025 | $37.0K9 Dec 31, 2024 | +421.6% |
Properties, in its own words
We own an office complex in Austin, Texas, a portion of which serves as our corporate headquarters. Maintenance, physical facilities, leasing, property management and other key responsibilities related to property ownership are outsourced to professional real-estate managers. The office complex measures approximately 90,000 rentable square feet. We occupied approximately 25% of the property as of December 31, 2025.
Item 2 of the 10-K filed Mar 12, 2026.4
Leadership
Who has led FILANA THERAPEUTICS, INC., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
2010201520202025
- Chief executive officerRemi Barbier Feb 7, 2006 to May 22, 202414
- ChairRemi Barbier Sep 16, 2009 to Oct 9, 201815
- PresidentRemi Barbier Feb 23, 2006 to May 22, 202416
- Chief financial officerEric Schoen Oct 31, 2018 to now17
- Chief financial officerPeter S. Roddy Feb 10, 2006 to Apr 15, 201618
- Chief operating officerRobert Christopher Cook Apr 21, 2025 to now19
- Chief operating officerNadav Friedmann Mar 16, 2006 to Apr 15, 201620
Board members and other officers (20)
- Chief Commercial OfficerFreda Nassif Nov 20, 2024 to now21
- Chief Clinical Dev. OfficerJaren Landen Nov 20, 2024 to Nov 20, 202422
- Chief Clinical Dev. OfficerJames William Kupiec Jan 11, 2021 to Dec 3, 202423
- Chief Fnancial OfficerPeter S. Roddy Oct 17, 2012 to Jul 15, 201424
- Chief Scientific OfficerGrant Schoenhard Jun 12, 2006 to Jul 15, 201425
- Operating & Med. OfficerNadav Friedmann Nov 1, 2006 to Jan 3, 202326
- Board memberDawn Carter Bir Oct 22, 2025 to now27
- Board memberPierre Gravier Dec 7, 2023 to now28
- Board memberClaude Nicaise Dec 8, 2023 to now29
- Board memberSaira Ramasastry Feb 12, 2013 to Dec 16, 201930
- Board memberPeter S. Roddy Jan 22, 2010 to Sep 10, 201031
- Board memberGrant Schoenhard Sep 10, 2010 to Mar 15, 201132
- Board memberPatrick J. Scannon Md. Phd. Dec 11, 2007 to now33
- Board memberRemi Barbier Feb 7, 2006 to May 22, 202414
- Board memberDonnell Michael J. O. Mar 6, 2006 to now34
- Board memberNadav Friedmann Mar 16, 2006 to Jan 3, 202320
- Board memberRobert Z. Gussin Jun 5, 2006 to now35
- Board memberSanford Robertson Jun 5, 2006 to May 16, 202436
- Board memberVernon R. Loucks Jr. Jun 5, 2006 to Sep 24, 200737
- General counselRobert Christopher Cook Oct 31, 2022 to Sep 9, 202438
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- Austin Innovation Park, LLC Texas3
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Former names
Timeline
- Sep 22, 20268-K Regulation FD disclosure; Other events39
- Sep 18, 20268-K Listing notice or transfer40
- Jul 29, 20268-K Results of operations41
- Jun 15, 20268-K Executive or director change; Shareholder vote42
- May 7, 20268-K Results of operations43
- Apr 28, 20268-K Executive or director change44
- Mar 12, 20268-K Results of operations45
- Mar 10, 20268-K Bylaws or fiscal year changed; Regulation FD disclosure46
- Feb 19, 20268-K Regulation FD disclosure; Other events47
- Dec 23, 20258-K Entered a material agreement48
- Dec 22, 20258-K Executive or director change49
- Dec 18, 20258-K Other events50
- Feb 7, 2006New chief executive Remi Barbier becomes CEO14
Calendar
Coming up
- Nov 11, 2026Reports results for the quarter ending Sep/202651
When it reported results
- Jul 29, 2026Reported quarterly or annual results41
- May 7, 2026Reported quarterly or annual results43
- Mar 12, 2026Reported quarterly or annual results45
- Nov 12, 2025Reported quarterly or annual results52
- Aug 14, 2025Reported quarterly or annual results53
- May 8, 2025Reported quarterly or annual results54
- Mar 3, 2025Reported quarterly or annual results55
- Jan 7, 2025Reported quarterly or annual results56
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
228 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 77 major events, 87 insider forms, 14 large holders, 30 other. The latest 20:
- Oct 1, 20264 EDGAR
- Sep 30, 20264 EDGAR
- Sep 22, 20268-K EDGAR
- Sep 18, 20268-K EDGAR
- Jul 29, 202610-Q EDGAR
- Jul 29, 20268-K EDGAR
- Jun 15, 20268-K EDGAR
- May 7, 202610-Q EDGAR
- May 7, 20268-K EDGAR
- Apr 28, 2026ARS EDGAR
- Apr 28, 2026DEF 14A EDGAR
- Apr 28, 20268-K EDGAR
- Mar 12, 202610-K EDGAR
- Mar 12, 20268-K EDGAR
- Mar 10, 20268-K EDGAR
- Feb 19, 20268-K EDGAR
- Dec 23, 20258-K EDGAR
- Dec 22, 20258-K/A EDGAR
- Dec 18, 20258-K EDGAR
- Dec 17, 20258-K EDGAR
The 228 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
19 open-market trades by officers, directors and large owners since October 2021: 17 buys and 2 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Sep 28, 2026 | Barry RichardPresident & CEO | Buy | 93,091 | $0.84 | $78.2K | Form 4 |
| Nov 24, 2025 | Anderson Robert Eugene JrDirector | Buy | 8,600 | $2.90 | $24.9K | Form 4 |
| Nov 20, 2025 | Barry RichardPresident & CEO | Buy | 150,000 | $2.76 | $414.0K | Form 4 |
| Nov 19, 2025 | Barry RichardPresident & CEO | Buy | 73,385 | $2.75 | $201.8K | Form 4 |
| Sep 30, 2025 | Cook Robert ChristopherChief Operating & Legal Office | Buy | 13,725 | $2.91 | $39.9K | Form 4 |
| Sep 22, 2025 | Barry RichardPresident & CEO | Buy | 7,172 | $2.28 | $16.4K | Form 4 |
| Sep 19, 2025 | Barry RichardPresident & CEO | Buy | 47,308 | $2.29 | $108.3K | Form 4 |
| Sep 18, 2025 | Barry RichardPresident & CEO | Buy | 190,633 | $2.24 | $426.4K | Form 4 |
| Nov 29, 2024 | Kupiec James WilliamChief Medical Officer | Sale | 4,000 | $3.87 | $15.5K | Form 4 |
| Nov 29, 2024 | Schoen EricChief Financial Officer | Sale | 61,800 | $3.86 | $238.5K | Form 4 |
| Aug 23, 2023 | ROBERTSON SANFORDDirector | Buy | 30,000 | $17.45 | $523.5K | Form 4 |
| Aug 22, 2023 | Barry RichardPresident & CEO | Buy | 16,571 | $16.65 | $275.9K | Form 4 |
| Aug 21, 2023 | Barry RichardPresident & CEO | Buy | 1,906 | $16.80 | $32.0K | Form 4 |
| Mar 7, 2023 | Barry RichardPresident & CEO | Buy | 77,276 | $25.76 | $2.0M | Form 4 |
| Mar 6, 2023 | Barry RichardPresident & CEO | Buy | 11,565 | $26.13 | $302.2K | Form 4 |
| Aug 23, 2022 | Barry RichardPresident & CEO | Buy | 36,159 | $23.79 | $860.2K | Form 4 |
| Aug 23, 2022 | Kupiec James WilliamChief Medical Officer | Buy | 2,500 | $24.44 | $61.1K | Form 4 |
| Aug 12, 2022 | Schoen EricChief Financial Officer | Buy | 2,500 | $19.95 | $49.9K | Form 4 |
| Aug 12, 2022 | ROBERTSON SANFORDDirector | Buy | 100,000 | $20.69 | $2.1M | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- VANGUARD GROUP INCSCHEDULE 13G/A, 4 filings Feb 9, 2022 to Jul 29, 202557
- BlackRockSCHEDULE 13G/A, 4 filings Feb 3, 2022 to Jul 16, 202558
- Matthew NachtrabSCHEDULE 13G/A, 2 filings Aug 21, 2024 to Nov 26, 202459
- Remi BarbierSC 13G/A, 3 filings Feb 3, 2022 to Nov 4, 202460
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 84. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Vanguard Capital Management LLC | 1,974,981 | $2.4M | 0.0% | +44,038 |
| Two Sigma Investments, LP | 1,711,358 | $2.0M | 0.0% | −277,456 |
| Marshall Wace, Llp | 1,597,548 | $1.9M | 0.0% | −414,995 |
| BlackRock, Inc. | 1,453,561 | $1.7M | 0.0% | +39,047 |
| Goldman Sachs Group Inc | 668,792 | $795.9K | 0.0% | +627,468 |
| Geode Capital Management, LLC | 615,510 | $732.7K | 0.0% | +19,268 |
| D. E. Shaw & Co., Inc. | 485,025 | $577.2K | 0.0% | −74,180 |
| GMT Capital Corp | 450,100 | $535.6K | 0.0% | No change |
| Renaissance Technologies LLC | 389,601 | $463.6K | 0.0% | +62,842 |
| Squarepoint Ops LLC | 318,380 | $378.9K | 0.0% | New |
| Vanguard Fiduciary Trust Co | 315,889 | $375.9K | 0.0% | +41,958 |
| Susquehanna International Group, Llp | 292,017 | $347.5K | 0.0% | −155,261 |
| Group One Trading LLC | 244,008 | $290.4K | 0.0% | −58,616 |
| State Street Corp | 209,105 | $248.8K | 0.0% | −30,882 |
| Vanguard Portfolio Management LLC | 132,597 | $157.8K | 0.0% | −96 |
| Connor, Clark & Lunn Investment Management Ltd. | 132,298 | $157.4K | 0.0% | −4,633 |
| Federated Hermes, Inc. | 119,952 | $142.7K | 0.0% | +4,855 |
| Northern Trust Corp | 114,322 | $136.0K | 0.0% | −34,872 |
| Simplex Trading, LLC | 99,879 | $118.9K | 0.0% | −40,116 |
| Stifel Financial Corp | 75,000 | $89.2K | 0.0% | New |
| XTX Topco Ltd | 64,614 | $76.9K | 0.0% | +31,311 |
| Jane Street Group, LLC | 58,981 | $70.2K | 0.0% | −166,183 |
| Verition Fund Management LLC | 46,870 | $55.8K | 0.0% | +8,726 |
| LPL Financial LLC | 40,172 | $47.8K | 0.0% | −821 |
| UBS Group AG | 39,062 | $46.5K | 0.0% | +27,459 |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How FILANA THERAPEUTICS, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARFILANA THERAPEUTICS, INC.1
- CIK0001069530
- Employer ID (EIN)91-19113364
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address6801 N Capital Of Texas Highway, Building 1; Suite 300, Austin, TX 787311
- Phone512-501-24441
- Shares outstanding48,307,896 as of May 4, 202612
- Public float$87.0M as of Jun 30, 20254
- AuditorErnst & Young LLP, Austin, Texas PCAOB ID 42; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceMar 14, 20001
- Filings1,219 in all: 4 (550), 8-K (244), SC 13G/A (103), 10-Q (79), SC 13G (38), DEF 14A (26), 10-K (25), 3 (17)1
All 41 form types
4/A (11), 424B5 (11), CORRESP (11), UPLOAD (11), S-8 (10), S-3 (9), S-3/A (7), ARS (6), EFFECT (6), 5 (5), CT ORDER (5), 8-K/A (4), PRE 14A (4), 10-K/A (3), 424B2 (3), 8-A12G (3), 8-A12G/A (3), S-1/A (3), SCHEDULE 13G/A (3), 144 (2), 424B1 (2), DEFA14A (2), S-1 (2), S-3ASR (2), 10-K405 (1), 25-NSE (1), 424B3 (1), 8-A12B (1), CERT (1), D (1), FWP (1), RW (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Mar 12, 2026
Quarterly report (10-Q) Jul 29, 2026
Proxy statement (DEF 14A) Apr 28, 2026
Latest 8-K (8-K) Sep 22, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.001 par value | FLNA | NASDAQ |
From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks FILANA THERAPEUTICS, INC. names in Item 1A of its 10-K filed Mar 12, 2026: 75 risks under these headings, as written.4
- Risks Related to the Discovery, Development, and Commercialization of Our Product Candidates
- Risks Related to Government Regulation and Other Legal Compliance Matters
- Risks Related to Our Intellectual Property
- Risks Related to Our Business and Operations
- Risks Related to Financial Condition and Capital Requirements
- Risks Related to the Ownership of Our Common Stock
- We have no approved products. Our product candidates are subject to significant development risk, and we may never achieve regulatory approval or commercial success
- The FDA has placed a full clinical hold on our planned clinical studies, which may cause our business to suffer.
- Our product candidates are based on new scientific approaches and novel technology, which makes it difficult to predict the time and cost of product candidate development and likelihood of success.
- The drug development process, the clinical trial process and the enrollment and retention of patients in clinical trials could be challenging, expensive and time-consuming for the indications that we are targeting.
- We are heavily dependent on the success of simufilam, our lead product candidate, which is under development. If this product candidate is unsuccessful in clinical development or does not receive regulatory approval, we will be unable to generate product revenue and our business will be harmed.
- We have a limited operating history in our business targeting TSC-related epilepsy and no history of product approvals for commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability.
The other 68 risks
- We may not be able to obtain orphan drug exclusivity for our product candidates in the United States or the European Union.
- Our inability to develop formulations of simufilam appropriate for pediatric patients under the age of 12 could delay or prevent clinical trials of simufilam in that population.
- We cannot give any assurance that we will file for regulatory approval for any of our product candidates or that, if we file for approval, our product candidates will receive regulatory approval, which is necessary before they can be commercialized.
- There can be no assurance that promising results of preclinical studies or Phase 1 or Phase 2 clinical trials with simufilam will be reproduced in later stage studies, including Phase 3 studies.
- Results observed in preclinical studies and early stage clinical trials for simufilam are not sufficient evidence of drug safety or efficacy for purposes of regulatory approval.
- We may encounter substantial delays in the clinical studies that we conduct or may not be able to conduct or complete our clinical studies on the timelines we expect, if at all.
- Governmental actions with respect to U.S. drug prices could negatively impact our business.
- If physicians and patients do not accept and use our drugs, we will not achieve sufficient product revenues and our business will suffer.
- We may not be successful in developing our product candidates in neurodegeneration or other forms of central nervous system disorders .
- Interim, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time are likely to change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final dataset.
- We currently do not have the in-house capabilities to manufacture or commercialize our product candidates, and we rely on a third-party commercial drug manufacturing organization for supplies of simufilam. If we are unable to develop our own manufacturing, sales, marketing and distribution capabilities, or if we are not successful in contracting with third parties for these services on favorable terms, or at all, our product revenues could be adversely impacted.
- We rely on third parties to conduct our studies and some aspects of our research, and such third parties may not perform satisfactorily, which could delay or harm our studies, research, and testing.
- We may not be successful in our efforts to expand our technology or product candidates in other indications.
- If we fail to successfully identify and develop additional product candidates, our commercial opportunity will be limited.
- Our clinical studies may fail to demonstrate substantial evidence of the safety and efficacy of our product candidates and may suffer from improper or inadequate study design or enrollment criteria, which would prevent, delay, or limit the scope of regulatory approval and commercialization.
- The market opportunities for simufilam, if approved, may be smaller than we anticipate.
- We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that additional competitors may achieve regulatory approval before us or develop therapies that are safer, more advanced, or more effective than ours, any of which may harm our business operations.
- Our financial condition and operating results could be adversely impacted by unfavorable results of legal proceedings, government investigations or allegations and other claims.
- Additional future litigation involving us could be costly and time-consuming to defend.
- If we are ultimately unable to file for and obtain regulatory approval for our product candidates, we will be unable to generate product revenue, and our business will be substantially harmed.
- Our application to register our new corporate name as a trademark may be denied, which could adversely affect our business.
- Our ability to market and promote our product candidates will be determined and limited by FDA-approved labeling.
- The FDA may change the statutory requirements for drug approval.
- Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- If we fail to comply or stay in compliance with the complex set of federal, state, local and foreign laws and regulations that apply to our business, we could suffer severe consequences that could materially and adversely affect our operating results and financial condition.
- Government agencies may establish and promulgate usage guidelines that could limit the use of our product candidates.
- Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences.
- We may be subject to legal liability associated with clinical trials.
- Our insurance policies may be inadequate and potentially expose us to unrecoverable risks.
- If our product candidates receive regulatory approval, we and our collaborators will be subject to ongoing FDA obligations and continued regulatory review, such as continued safety reporting requirements, and we and our collaborators may also be subject to additional FDA post-marketing obligations or new regulations, all of which may result in significant expense and limit our and our collaborators’ ability to commercialize our potential drugs.
- Enacted and future legislation may increase the difficulty and cost for us to commercialize our product candidates and may reduce the prices we are able to obtain for our product candidates.
- Our relationships with customers and payors will be subject to applicable anti-kickback, fraud and abuse, transparency, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.
- If we are unable to obtain and maintain sufficient patent protection for any product candidates, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop may be adversely affected.
- Issued patents covering our product candidates and other technologies could be found invalid or unenforceable if challenged in court or before administrative bodies in the U.S. or abroad.
- If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- If any of our patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively.
- If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical technology and product candidates would be adversely affected.
- We may not be able to protect our intellectual property and proprietary rights throughout the world.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- We may not be successful in obtaining necessary rights to our product candidates or other technologies.
- Our expansion into additional indications may face challenges if we are unable to obtain additional intellectual property rights that may be necessary or desirable.
- We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property which may prevent or delay the development of our product candidates.
- We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming, and unsuccessful.
- Intellectual property rights do not necessarily address all potential threats.
- We have been and may in the future be subject to lawsuits and governmental investigations and inquiries.
- Our current dependence on single source suppliers for our drug substance and drug product could materially adversely affect our ability to manufacture our product candidates and materially increase our costs.
- Inadequate Congressional funding for the FDA, the SEC and other U.S. government agencies or comparable foreign regulatory authorities, including from government shut downs, or other disruptions to these agencies’ operations, could hinder these agencies’ ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent government agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Our reliance on third parties for both the supply and manufacture of materials for our product candidates carries the risk that we will not have sufficient quality or quantities of such materials or product candidates, or that such supply will not be available to us at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts.
- Our employees, principal investigators, consultants and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
- Failure to comply with laws regarding data privacy could expose us to risk of enforcement actions and penalties under such laws.
- Ownership of our corporate headquarters and property leasing are subject to numerous risks and uncertainties.
- Our internal computer systems, or those used by third parties on whom we rely, may fail or suffer other breakdowns, cyberattacks, or information security breaches that could compromise the confidentiality, integrity, and availability of such systems and data, result in material disruptions of our development programs and business operations, risk disclosure of confidential, financial, or proprietary information, and affect our reputation.
- Our reliance on third parties requires us to share our proprietary information, which increases the possibility that a competitor will discover this information or that our proprietary information will be misappropriated or inadvertently disclosed.
- Our business involves environmental risks that may result in liability for us.
- Business disruptions and lack of appropriate levels of commercial insurance could seriously harm our future revenue and financial condition and increase our costs and expenses.
- Social media platforms have significantly altered the dynamics of corporate communications and present risks and challenges, some of which are and may continue to be unknown to us.
- We are a small company with a limited number of employees. We are highly dependent on our key personnel, and if we are not successful in attracting, motivating, and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- We may need to cease our operations if we are unable to attract and retain key personnel.
- If our current research collaborators or scientific advisors terminate their relationships with us or develop relationships with a competitor, our ability to continue our business operations could be adversely affected.
- Our business may be impacted by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties beyond our control.
- Our efforts to minimize the likelihood and impact of a cybersecurity incident may not be successful and our business could be negatively affected by a data breach or other cybersecurity threat or other disruption to our operations, which could result in legal claims against us or could give rise to substantial financial costs to redress any such cybersecurity incident and could harm our relationship with vendors, clinical study participants or regulators.
- We have incurred significant net losses in each period since our inception and anticipate that we will continue to incur net losses for the foreseeable future.
- We have broad discretion in the use of our capital resources, including the net proceeds from any of our financing transactions, and we may not use them effectively.
- We have no product revenues and may never achieve revenues or profitability based on product revenues.
Legal proceedings
We are, and from time to time, we may become involved in litigation or other legal proceedings and claims, including U.S. government inquiries, investigations and Citizen Petitions submitted to FDA. In addition, we have received and from time to time may receive inquiries from government authorities relating to matters arising from the ordinary course of business. The outcome of these proceedings is inherently uncertain. Regardless of outcome, legal proceedings can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. At this time, no assessment can be made as to their likely outcome or whether the outcome will be material to us except as disclosed in this Annual Report on Form 10-K in Note 11 to our consolidated financial statements entitled, “Contingencies.” We believe that our total provisions for legal matters are adequate based upon currently available information. Additional information regarding our legal proceedings is included in the “Contingencies” note.
The opening of Item 3, Legal Proceedings.4
Sources
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- 15SEC EDGARRemi Barbier, Chair
- 16SEC EDGARRemi Barbier, President
- 17SEC EDGAREric Schoen, Chief financial officer
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- 27SEC EDGARDawn Carter Bir, Board member
- 28SEC EDGARPierre Gravier, Board member
- 29SEC EDGARClaude Nicaise, Board member
- 30SEC EDGARSaira Ramasastry, Board member
- 31SEC EDGARPeter S. Roddy, Board member
- 32SEC EDGARGrant Schoenhard, Board member
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- 34SEC EDGARDonnell Michael J. O., Board member
- 35SEC EDGARRobert Z. Gussin, Board member
- 36SEC EDGARSanford Robertson, Board member
- 37SEC EDGARVernon R. Loucks Jr., Board member
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- 40SEC EDGARListing notice or transfer
- 41SEC EDGARResults of operations
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- 43SEC EDGARResults of operations
- 44SEC EDGARExecutive or director change
- 45SEC EDGARResults of operations
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- 48SEC EDGAREntered a material agreement
- 49SEC EDGARExecutive or director change
- 50SEC EDGAROther events
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